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1. Frankel AE, Fleming DR, Hall PD, Powell BL, Black JH, Leftwich C, Gartenhaus R: A phase II study of DT fusion protein denileukin diftitox in patients with fludarabine-refractory chronic lymphocytic leukemia. Clin Cancer Res; 2003 Sep 1;9(10 Pt 1):3555-61
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  • [Title] A phase II study of DT fusion protein denileukin diftitox in patients with fludarabine-refractory chronic lymphocytic leukemia.
  • PURPOSE: Patients with relapsed or refractory chronic lymphocytic leukemia (CLL) have a poor prognosis.
  • We tested the safety and efficacy in these patients of a diphtheria fusion protein DAB(389)IL2 (denileukin diftitox) directed against the interleukin 2 receptor that is expressed by CLL cells.
  • Two had Rai stage I, 6 had Rai stage II, and 10 had Rai stage IV.
  • The mean number of prior treatments was 4.5 (range, 1-11).
  • Responses were evaluated by peripheral CLL counts, computed tomography scans of all nodes and bone marrow biopsies.
  • Eleven of 12 patients showed reductions of peripheral CLL cells, with 6 of 11 showing >/==" BORDER="0">95% reductions.
  • Seven of 12 patients showed reductions of node diameters on exam and computed tomography scans, and 2 of 12 showed 60 and 80% shrinkage, respectively.
  • Pre and postbone marrow biopsies showed a reduction in CLL marrow index in 11 patients.
  • CONCLUSIONS: DAB(389)IL2 produced a rapid decrease of leukemic cells in the bone marrow and peripheral blood of most chemotherapy refractory CLL patients.
  • The results suggest DAB(389)IL2 has biological activity in patients with B-cell CLL.
  • [MeSH-major] Diphtheria Toxin / therapeutic use. Drug Resistance, Neoplasm. Interleukin-2 / therapeutic use. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy. Recombinant Fusion Proteins / therapeutic use. Vidarabine / analogs & derivatives. Vidarabine / therapeutic use
  • [MeSH-minor] Aged. Antineoplastic Agents / therapeutic use. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Bone Marrow / pathology. Bone Marrow Cells. Female. Humans. Male. Middle Aged. Prognosis. Time Factors. Tomography, Emission-Computed. Treatment Outcome

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  • [CommentIn] Clin Cancer Res. 2004 May 15;10(10):3572-5 [15161717.001]
  • (PMID = 14506141.001).
  • [ISSN] 1078-0432
  • [Journal-full-title] Clinical cancer research : an official journal of the American Association for Cancer Research
  • [ISO-abbreviation] Clin. Cancer Res.
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Diphtheria Toxin; 0 / Interleukin-2; 0 / Recombinant Fusion Proteins; 25E79B5CTM / denileukin diftitox; FA2DM6879K / Vidarabine; P2K93U8740 / fludarabine
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2. Shanafelt TD, Call TG, Zent CS, LaPlant B, Bowen DA, Roos M, Secreto CR, Ghosh AK, Kabat BF, Lee MJ, Yang CS, Jelinek DF, Erlichman C, Kay NE: Phase I trial of daily oral Polyphenon E in patients with asymptomatic Rai stage 0 to II chronic lymphocytic leukemia. J Clin Oncol; 2009 Aug 10;27(23):3808-14
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  • [Title] Phase I trial of daily oral Polyphenon E in patients with asymptomatic Rai stage 0 to II chronic lymphocytic leukemia.
  • PURPOSE: To define the optimal dose of Polyphenon E for chronic daily administration and tolerability in patients with chronic lymphocytic leukemia (CLL).
  • PATIENTS AND METHODS: Previously untreated patients with asymptomatic Rai stage 0 to II CLL were eligible for participation.
  • Trough plasma EGCG levels were measured 1 month after initiation of therapy.
  • Other signs of clinical activity were also observed, with 11 patients (33%) having a sustained > or = 20% reduction in absolute lymphocyte count (ALC) and 11 (92%) of 12 patients with palpable adenopathy experiencing at least a 50% reduction in the sum of the products of all nodal areas during treatment.
  • Trough plasma EGCG levels after 1 month of treatment ranged from 2.9 to 3,974 ng/mL (median, 40.4 ng/mL).
  • CONCLUSION: Daily oral EGCG in the Polyphenon E preparation was well tolerated by CLL patients in this phase I trial.
  • A phase II trial to evaluate efficacy using 2,000 mg twice a day began in November 2007.
  • [MeSH-major] Anticarcinogenic Agents / therapeutic use. Catechin / analogs & derivatives. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy. Leukemia, Lymphocytic, Chronic, B-Cell / pathology
  • [MeSH-minor] Administration, Oral. Adult. Aged. Female. Humans. Male. Middle Aged. Neoplasm Staging. Patient Selection. Tea. Treatment Outcome

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  • (PMID = 19470922.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / K23 CA113408; United States / NCI NIH HHS / CA / R01 CA136591; United States / NCI NIH HHS / CA / CA113408; United States / NCI NIH HHS / CA / CA6912
  • [Publication-type] Clinical Trial, Phase I; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Anticarcinogenic Agents; 0 / Tea; 0 / polyphenon E; 8R1V1STN48 / Catechin; BQM438CTEL / epigallocatechin gallate
  • [Other-IDs] NLM/ PMC2727287
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3. Pangalis GA, Siakantaris MP, Angelopoulou MK, Vassilakopoulos TP, Dimopoulou MN, Kyrtsonis MC, Konstantopoulos K, Tsaftaridis P, Vaiopoulos GA, Kontopidou FN: Downstaging Rai stage III B-chronic lymphocytic leukemia patients with the administration of recombinant human erythropoietin. Haematologica; 2002 May;87(5):500-6
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  • [Title] Downstaging Rai stage III B-chronic lymphocytic leukemia patients with the administration of recombinant human erythropoietin.
  • BACKGROUND AND OBJECTIVES: To investigate the effectiveness of recombinant human erythropoietin (r-HuEPO) on disease-related anemia in patients with B-chronic lymphocytic leukemia (B-CLL) and to explore whether improvement of anemia could delay the initiation of cytotoxic therapy.
  • DESIGN AND METHODS: Twenty five B-CLL patients (12 males and 13 females; median age 70 years) with disease-related anemia were treated with r-HuEPO.
  • Patients were either on no treatment or on a standard regimen, and had at least Rai stage III disease, with a hematocrit (Hct) <32%.
  • Eleven were newly diagnosed, whereas 14 developed anemia during follow-up.
  • Treatment induction lasted for a maximum of 3 months, during which patients were receiving 150 IU/kg of r-HuEPO s.c. t.i.w. with an escalation to 300 IU/kg t.i.w. if response was slow after one month.
  • Complete response (CR) was defined as an increase of Hct to 38% or more and partial response (PR) as an increase of >6% from pretreatment level.
  • RESULTS: CR was observed in 18/25 (72%) and PR in 2/25 (8%) of the patients.
  • Six patients were downstaged to stage Rai 0, 9 to Rai I and 4 to Rai II.
  • Response was sustained with maintenance therapy.
  • At a median follow-up of 32 months only 4 of the responders required antileukemic treatment.
  • INTERPRETATION AND CONCLUSIONS: r-HuEPO was efficient in downstaging Rai stage III B-CLL patients, and delayed the initiation of antileukemic therapy.
  • [MeSH-major] Erythropoietin / administration & dosage. Leukemia, Lymphocytic, Chronic, B-Cell / complications. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy. Neoplasm Staging
  • [MeSH-minor] Aged. Aged, 80 and over. Anemia / drug therapy. Anemia / etiology. Female. Humans. Male. Middle Aged. Recombinant Proteins. Remission Induction. Treatment Outcome

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  • (PMID = 12010663.001).
  • [ISSN] 0390-6078
  • [Journal-full-title] Haematologica
  • [ISO-abbreviation] Haematologica
  • [Language] eng
  • [Publication-type] Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] Italy
  • [Chemical-registry-number] 0 / Recombinant Proteins; 11096-26-7 / Erythropoietin
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4. Chen R, Keating MJ, Gandhi V, Plunkett W: Transcription inhibition by flavopiridol: mechanism of chronic lymphocytic leukemia cell death. Blood; 2005 Oct 1;106(7):2513-9
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  • [Title] Transcription inhibition by flavopiridol: mechanism of chronic lymphocytic leukemia cell death.
  • Flavopiridol is active against chronic lymphocytic leukemia (CLL) cells in vitro and in the treatment of advanced stage disease, but the mechanisms of these actions remain unclear.
  • Originally developed as a general cyclin-dependent kinase inhibitor, flavopiridol is a potent transcriptional suppressor through the inhibition of positive transcription elongation factor b (P-TEFb; CDK9/cyclin T).
  • P-TEFb phosphorylates the C-terminal domain (CTD) of RNA polymerase II to promote transcriptional elongation.
  • Because most CLL cells are not actively cycling, and their viability is dependent upon the continuous expression of antiapoptotic proteins, we hypothesized that flavopiridol induces apoptosis in CLL cells through the transcriptional down-regulation of such proteins.
  • This study demonstrated that flavopiridol inhibited the phosphorylation of the CTD of RNA polymerase II in primary CLL cells and reduced RNA synthesis.
  • This was associated with a decline of the transcripts and the levels of short-lived antiapoptotic proteins such as myeloid cell leukemia 1 (Mcl-1), and resulted in the induction of apoptosis.
  • The dependence of CLL-cell survival on short-lived oncoproteins may provide the biochemical basis for the therapeutic index in response to flavopiridol.

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  • (PMID = 15972445.001).
  • [ISSN] 0006-4971
  • [Journal-full-title] Blood
  • [ISO-abbreviation] Blood
  • [Language] ENG
  • [Grant] United States / NCI NIH HHS / CA / CA100632; United States / NCI NIH HHS / CA / CA81534
  • [Publication-type] Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Flavonoids; 0 / Myeloid Cell Leukemia Sequence 1 Protein; 0 / Neoplasm Proteins; 0 / Piperidines; 0 / Proto-Oncogene Proteins c-bcl-2; 0 / RNA, Messenger; 45AD6X575G / alvocidib; 63231-63-0 / RNA; EC 2.4.2.30 / Poly(ADP-ribose) Polymerases; EC 2.7.7.- / RNA Polymerase II
  • [Other-IDs] NLM/ PMC1895272
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5. Kim K, Visintin I, Alvero AB, Mor G: Development and validation of a protein-based signature for the detection of ovarian cancer. Clin Lab Med; 2009 Mar;29(1):47-55
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  • [Title] Development and validation of a protein-based signature for the detection of ovarian cancer.
  • CA-125 testing is used to monitor response to chemotherapy, detect recurrence, and detect late stage ovarian cancer.
  • However, CA-125 testing, alone or in combination with ultrasonography, has not been adequate for early detection of ovarian cancer.
  • This article discusses the authors' recent report of a novel multiplex assay that uses a panel of six serum biomarkers: leptin, prolactin, osteopontin, insulin-like growth factor II (IGF-II), macrophage inhibitory factor (MIF), and CA-125.

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  • (PMID = 19389550.001).
  • [ISSN] 1557-9832
  • [Journal-full-title] Clinics in laboratory medicine
  • [ISO-abbreviation] Clin. Lab. Med.
  • [Language] ENG
  • [Grant] United States / NCI NIH HHS / CA / R01 CA127913-01A2; United States / NCI NIH HHS / CA / R01 CA118678; United States / NCI NIH HHS / CA / R01 CA118678-02; United States / NCI NIH HHS / CA / CA127913-01A2; United States / NCI NIH HHS / CA / R01 CA127913; United States / NCI NIH HHS / CA / CA118678-02
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't; Review
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Biomarkers, Tumor
  • [Number-of-references] 35
  • [Other-IDs] NLM/ NIHMS119645; NLM/ PMC2720626
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6. Schulz H, Klein SK, Rehwald U, Reiser M, Hinke A, Knauf WU, Aulitzky WE, Hensel M, Herold M, Huhn D, Hallek M, Diehl V, Engert A, German CLL Study Group: Phase 2 study of a combined immunochemotherapy using rituximab and fludarabine in patients with chronic lymphocytic leukemia. Blood; 2002 Nov 1;100(9):3115-20
The Lens. Cited by Patents in .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase 2 study of a combined immunochemotherapy using rituximab and fludarabine in patients with chronic lymphocytic leukemia.
  • This multicenter phase 2 trial investigated safety and efficacy of a new immunochemotherapeutic regimen combining rituximab (R) and fludarabine (F) in patients with fludarabine- and anthracycline-naive chronic lymphocytic leukemia (CLL).
  • The rationale for using R + F includes single-agent efficacy of both drugs, in vitro synergism of R and F, and no apparent overlapping toxicity.
  • Of 31 eligible patients with B-CLL enrolled, 20 were previously untreated and 11 relapsed.
  • Treatment consisted of fludarabine administered at standard doses (25 mg/m(2)/d; days 1-5, 29-33, 57-61, and 85-89) and rituximab (375 mg/m(2)/d) given on days 57, 85, 113, and 151.
  • The overall response rate (complete remission [CR] and partial remission [PR]) was 87% (27 of 31 evaluable patients).
  • Ten of 31 patients achieved CR (5 of 20 untreated; 5 of 11 pretreated; 9 of 21 Binet stage B, 1 of 10 Binet stage C).
  • We conclude that the combination of rituximab and fludarabine is feasible and effective in patients with B-CLL.
  • [MeSH-major] Antibodies, Monoclonal / therapeutic use. Antimetabolites, Antineoplastic / therapeutic use. Immunotherapy. Leukemia, Lymphocytic, Chronic, B-Cell / therapy. Vidarabine / analogs & derivatives. Vidarabine / therapeutic use
  • [MeSH-minor] Adult. Aged. Antibodies, Monoclonal, Murine-Derived. Cerebral Hemorrhage / chemically induced. Chills / chemically induced. Combined Modality Therapy. Disease-Free Survival. Drug Administration Schedule. Female. Fever / chemically induced. Humans. Infection / epidemiology. Life Tables. Male. Middle Aged. Neutropenia / chemically induced. Prospective Studies. Remission Induction. Rituximab. Thrombocytopenia / chemically induced. Treatment Outcome

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  • (PMID = 12384407.001).
  • [ISSN] 0006-4971
  • [Journal-full-title] Blood
  • [ISO-abbreviation] Blood
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Multicenter Study
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antibodies, Monoclonal, Murine-Derived; 0 / Antimetabolites, Antineoplastic; 4F4X42SYQ6 / Rituximab; FA2DM6879K / Vidarabine; P2K93U8740 / fludarabine
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7. Kay NE, Shanafelt TD, Call TG, Wu W, Laplant BR: N9986: a phase II trial of thalidomide in patients with relapsed chronic lymphocytic leukemia. Leuk Lymphoma; 2009 Apr;50(4):588-92
Hazardous Substances Data Bank. THALIDOMIDE .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] N9986: a phase II trial of thalidomide in patients with relapsed chronic lymphocytic leukemia.
  • We enrolled 28 eligible patients with relapsed chronic lymphocytic leukemia (CLL) to a phase II study of single agent thalidomide (200 mg/d, with dose escalation up to 1000 mg/d over 60 days).
  • Study participants received a median of 2 (range 1-7) prior treatment regimens and 61% had Rai stage 3-4 disease at enrollment.
  • Median time to progression for all 28 patients was 7.3 months.
  • Although thalidomide appears to have modest clinical activity in pretreated/relapsed CLL primarily based on reduction of the absolute lymphocyte count, in our opinion the toxicity profile precludes it from more active investigation in CLL.

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  • (PMID = 19373657.001).
  • [ISSN] 1029-2403
  • [Journal-full-title] Leukemia & lymphoma
  • [ISO-abbreviation] Leuk. Lymphoma
  • [Language] ENG
  • [Grant] United States / NCI NIH HHS / CA / R21 CA087155; United States / NCI NIH HHS / CA / CA 113408; United States / NCI NIH HHS / CA / CA 87155; United States / NCI NIH HHS / CA / CA95241; United States / NCI NIH HHS / CA / CA 116237; United States / NCI NIH HHS / CA / K23 CA113408; United States / NCI NIH HHS / CA / R01 CA116237; United States / NCI NIH HHS / CA / R01 CA095241
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Immunosuppressive Agents; 4Z8R6ORS6L / Thalidomide
  • [Other-IDs] NLM/ NIHMS549702; NLM/ PMC3928100
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8. Kaiser U: Cerebral involvement as the initial manifestation of chronic lymphocytic leukaemia. Acta Haematol; 2003;109(4):193-5

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Cerebral involvement as the initial manifestation of chronic lymphocytic leukaemia.
  • Stereotactic biopsy revealed infiltration by lymphocytes compatible with the diagnosis of chronic lymphocytic leukaemia (CLL).
  • Simultaneously, Binet stage II CLL with bone marrow infiltration was diagnosed.
  • Cranial radiotherapy with 36 Gy was performed.
  • Cerebral involvement is rare but may occur in early CLL.
  • In case of spinal fluid involvement intrathecal chemotherapy is recommended.
  • [MeSH-major] Basal Ganglia / pathology. Leukemia, Lymphocytic, Chronic, B-Cell / diagnosis. Leukemic Infiltration / pathology

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  • [Copyright] Copyright 2003 S. Karger AG, Basel
  • (PMID = 12853692.001).
  • [ISSN] 0001-5792
  • [Journal-full-title] Acta haematologica
  • [ISO-abbreviation] Acta Haematol.
  • [Language] eng
  • [Publication-type] Case Reports; Journal Article
  • [Publication-country] Switzerland
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9. Sieklucka M, Pozarowski P, Bojarska-Junak A, Hus I, Dmoszynska A, Rolinski J: Apoptosis in B-CLL: the relationship between higher ex vivo spontaneous apoptosis before treatment in III-IV Rai stage patients and poor outcome. Oncol Rep; 2008 Jun;19(6):1611-20

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Apoptosis in B-CLL: the relationship between higher ex vivo spontaneous apoptosis before treatment in III-IV Rai stage patients and poor outcome.
  • B-cell chronic lymphocytic leukaemia (B-CLL) has been described as the progressive accumulation of mature-appearing B cells in peripheral blood and bone marrow, resulting from failed apoptosis rather than from alterations in cell cycle regulation.
  • In this study, we aimed to examine the process of apoptosis in B-CLL patients before and during anti-cancer therapy, to answer the question of whether this parameter would presage the response to treatment and the clinical course of the disease.
  • We found that ex vivo spontaneous apoptosis was higher in advanced-stage (III-IV acc.
  • Rai) than in early-stage (I-II acc.
  • In I-II Rai stage patients the percentage of ex vivo apoptotic cells after chemotherapy was higher than that of apoptotic cells prior to treatment, whereas in III-IV Rai stage patients the percentage of ex vivo apoptotic cells after chemotherapy was lower than that of apoptotic cells before the anti-cancer therapy.
  • The results of our study, in the context of the cited literature, suggest a relationship between higher ex vivo spontaneous apoptosis before treatment in advanced-stage patients with a higher proliferation of leukaemic cells and poor outcome.
  • [MeSH-major] Apoptosis. Leukemia, Lymphocytic, Chronic, B-Cell / pathology

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  • (PMID = 18497973.001).
  • [ISSN] 1021-335X
  • [Journal-full-title] Oncology reports
  • [ISO-abbreviation] Oncol. Rep.
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article
  • [Publication-country] Greece
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10. Hallek M, Schmitt B, Wilhelm M, Busch R, Kröber A, Fostitsch HP, Sezer O, Herold M, Knauf W, Wendtner CM, Kuse R, Freund M, Franke A, Schriever F, Nerl C, Döhner H, Thiel E, Hiddemann W, Brittinger G, Emmerich B, German Chronic Lymphocytic Leukaemia Study Group: Fludarabine plus cyclophosphamide is an efficient treatment for advanced chronic lymphocytic leukaemia (CLL): results of a phase II study of the German CLL Study Group. Br J Haematol; 2001 Aug;114(2):342-8
Hazardous Substances Data Bank. VIDARABINE .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Fludarabine plus cyclophosphamide is an efficient treatment for advanced chronic lymphocytic leukaemia (CLL): results of a phase II study of the German CLL Study Group.
  • The efficacy and toxicity of a combination of fludarabine and cyclophosphamide (FC) was evaluated in patients with B-cell chronic lymphocytic leukaemia (CLL).
  • Between April 1997 and July 1998, 36 patients with CLL (median age 59 years) received a regimen that consisted of fludarabine 30 mg/m(2) in a 30-min IV infusion, d 1-3, and cyclophosphamide 250 mg/m(2) in a 30-min IV infusion on d 1-3.
  • Twenty-one patients had received between one and three different treatment regimens prior to the study, while 15 patients had received no prior therapy.
  • One patient was at Binet stage A, 18 were stage B and 17 patients were stage C.
  • No treatment-related deaths and no grade 3 or 4 infections occurred.
  • We conclude that the combination of fludarabine and cyclophosphamide showed significant activity in patients with CLL.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy
  • [MeSH-minor] Adult. Aged. Cyclophosphamide / administration & dosage. Cyclophosphamide / adverse effects. Female. Humans. Leukopenia / chemically induced. Male. Middle Aged. Neutropenia / chemically induced. Thrombocytopenia / chemically induced. Treatment Outcome. Vidarabine / administration & dosage. Vidarabine / adverse effects. Vidarabine / analogs & derivatives

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  • (PMID = 11529853.001).
  • [ISSN] 0007-1048
  • [Journal-full-title] British journal of haematology
  • [ISO-abbreviation] Br. J. Haematol.
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 8N3DW7272P / Cyclophosphamide; FA2DM6879K / Vidarabine; P2K93U8740 / fludarabine
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11. Khouri IF, Keating MJ, Saliba RM, Champlin RE: Long-term follow-up of patients with CLL treated with allogeneic hematopoietic transplantation. Cytotherapy; 2002;4(3):217-21
Hazardous Substances Data Bank. VIDARABINE .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Long-term follow-up of patients with CLL treated with allogeneic hematopoietic transplantation.
  • BACKGROUND: We investigated the long-term outcome of allogeneic stem-cell transplantation after myeloablative conditioning regimen as treatment for patients with chronic lymphocytic leukemia.
  • The median number of prior chemotherapy regimens per patient was 3.
  • The median follow-up time for the surviving patients was 66 months.
  • Progression-free survival at 5 years was 78% for the chemosensitive and 26% for those who were refractory to conventional chemotherapy at the time of transplantation (P = 0.03).
  • The actuarial risk of acute Grade II-IV GvHD was 49%.
  • Only one patient developed acute Grade III GvHD.
  • CONCLUSION: Allogeneic transplantation is probably curative for a subset of patients with chronic lymphocytic leukemia.
  • Patients should be considered for clinical trials involving allogeneic transplantation at an earlier stage prior acquiring chemorefractoriness.
  • [MeSH-major] Hematopoietic Stem Cell Transplantation. Leukemia, Lymphocytic, Chronic, B-Cell / therapy. Transplantation Conditioning. Vidarabine / analogs & derivatives
  • [MeSH-minor] Adult. Antineoplastic Agents / therapeutic use. Disease Progression. Disease-Free Survival. Female. Follow-Up Studies. Graft vs Host Disease / mortality. Humans. Male. Middle Aged. Recurrence. Survival Rate. Transplantation, Homologous. Treatment Outcome

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  • (PMID = 12194718.001).
  • [ISSN] 1465-3249
  • [Journal-full-title] Cytotherapy
  • [ISO-abbreviation] Cytotherapy
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antineoplastic Agents; FA2DM6879K / Vidarabine; P2K93U8740 / fludarabine
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12. Karlsson C, Lundin J, Kimby E, Kennedy B, Moreton P, Hillmen P, Osterborg A: Phase II study of subcutaneous alemtuzumab without dose escalation in patients with advanced-stage, relapsed chronic lymphocytic leukaemia. Br J Haematol; 2009 Jan;144(1):78-85

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase II study of subcutaneous alemtuzumab without dose escalation in patients with advanced-stage, relapsed chronic lymphocytic leukaemia.
  • This phase II study (n = 20) aimed to evaluate type, severity and duration of side-effects and efficacy following subcutaneous (SC) alemtuzumab, without dose-escalation, in advanced-stage relapsed chronic lymphocytic leukaemia (CLL) patients.
  • Alemtuzumab 30 and 3 mg was administered SC simultaneously day 1, followed by 30 mg three times per week.
  • 15/20 patients (75%) responded (12 partial responses, three complete responses) with a median time-to-treatment-failure of 20 months.
  • Optimized alemtuzumab therapy in properly selected patients may result in high efficacy even in advanced CLL.
  • [MeSH-major] Antibodies, Monoclonal / administration & dosage. Antibodies, Neoplasm / administration & dosage. Antineoplastic Agents / administration & dosage. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy
  • [MeSH-minor] Antibodies, Monoclonal, Humanized. Contusions. Drug Administration Schedule. Erythema. Female. Follow-Up Studies. Humans. Injections, Subcutaneous. Male. Middle Aged. Recurrence. Remission Induction. Thigh. Treatment Outcome

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  • (PMID = 19016731.001).
  • [ISSN] 1365-2141
  • [Journal-full-title] British journal of haematology
  • [ISO-abbreviation] Br. J. Haematol.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antibodies, Monoclonal, Humanized; 0 / Antibodies, Neoplasm; 0 / Antineoplastic Agents; 3A189DH42V / alemtuzumab
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13. Gahn B, Brittinger G, Dölken G, Döhner H, Emmerich B, Franke A, Freund M, Huber C, Kuse R, Scholten T, Hiddemann W: Multicenter phase II study of oral idarubicin in treated and untreated patients with B-chronic lymphocytic leukemia. Leuk Lymphoma; 2000 Mar;37(1-2):169-73
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  • [Title] Multicenter phase II study of oral idarubicin in treated and untreated patients with B-chronic lymphocytic leukemia.
  • Idarubicin is the first anthracycline that can be administered orally facilitating antineoplastic chemotherapy at an improved quality of life.
  • We performed a phase II study in 19 patients with untreated and pretreated B-CLL of Binet stage A-C.
  • Of 19 evaluable patients (m:f, 16:3, median age 64 years, range 41-80 years) 7 were previously untreated while 12 patients had received prior therapy with fludarabine, chlorambucil or similar non-anthracycline containing regimens.
  • 12 pts had Binet stage C, 5 Binet stage B and 2 Binet stage A.
  • There was no correlation of response rate with Binet stages or previous treatment regimens.
  • Treatment associated side effects consisted predominantly of mild nausea and vomiting (26%) as well as minor infections (21%) and diarrhoea (16%).
  • These data demonstrate that oral idarubicin as a single agent is well tolerated but of limited effectiveness in B-CLL.
  • [MeSH-major] Antibiotics, Antineoplastic / therapeutic use. Idarubicin / therapeutic use. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy

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  • (PMID = 10721782.001).
  • [ISSN] 1042-8194
  • [Journal-full-title] Leukemia & lymphoma
  • [ISO-abbreviation] Leuk. Lymphoma
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Multicenter Study
  • [Publication-country] SWITZERLAND
  • [Chemical-registry-number] 0 / Antibiotics, Antineoplastic; ZRP63D75JW / Idarubicin
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14. Dillman RO, Schreeder MT, Hon JK, Connelly EF, DePriest C, Cutter K: Community-based phase II trial of pentostatin, cyclophosphamide, and rituximab (PCR) biochemotherapy in chronic lymphocytic leukemia and small lymphocytic lymphoma. Cancer Biother Radiopharm; 2007 Apr;22(2):185-93
Hazardous Substances Data Bank. PENTOSTATIN .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Community-based phase II trial of pentostatin, cyclophosphamide, and rituximab (PCR) biochemotherapy in chronic lymphocytic leukemia and small lymphocytic lymphoma.
  • We conducted a multicenter, community-based phase II trial of PCR biochemotherapy (pentostatin 4 mg/m2, cyclophosphamide 600 mg/m2, and rituximab 375 mg/m2) every 3 weeks for up to 6 cycles in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
  • The study was stopped after enrolling 24 patients because of diminished investigator interest after 8 patients discontinued treatment because of adverse events, and 5 others died during treatment.
  • The median age of patients was 69 years; 11 patients were over age 70, and 71% had Rai stage III or IV disease.
  • The response rate among the 17 evaluable patients who completed 3 cycles of therapy was 58% (35%-81%, 95% confidence interval), with 2 complete responders (both greater than 70 years of age) and 7 partial responders.
  • No patients developed progressive disease while receiving PCR.
  • This is the first report of a trial in CLL utilizing a combination of purine analog, alkylator, and rituximab, in which most patients were older than 65 years and had high-risk disease.
  • PCR is active in CLL/SLL, but appears to be less active and associated with more complications in the community setting, compared to trials with younger, lower risk patients who travel to academic referral centers for treatment.
  • [MeSH-major] Antibodies, Monoclonal / immunology. Antibodies, Monoclonal / therapeutic use. Cyclophosphamide / therapeutic use. Delivery of Health Care. Leukemia, Lymphocytic, Chronic, B-Cell / therapy. Pentostatin / therapeutic use
  • [MeSH-minor] Adult. Aged. Antibodies, Monoclonal, Murine-Derived. Drug Therapy, Combination. Female. Humans. Immunotherapy / adverse effects. Male. Membrane Glycoproteins. Middle Aged. Rituximab. Survival Rate. Treatment Outcome

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  • [CommentIn] Cancer Biother Radiopharm. 2007 Oct;22(5):713-4; author reply 715-7 [17979574.001]
  • (PMID = 17600465.001).
  • [ISSN] 1084-9785
  • [Journal-full-title] Cancer biotherapy & radiopharmaceuticals
  • [ISO-abbreviation] Cancer Biother. Radiopharm.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antibodies, Monoclonal, Murine-Derived; 0 / Membrane Glycoproteins; 143891-49-0 / TI 1 protein, Mustela vison; 395575MZO7 / Pentostatin; 4F4X42SYQ6 / Rituximab; 8N3DW7272P / Cyclophosphamide
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15. Cotter F, Smith DA, Boyd TE, Richards DA, Alemany C, Loesch D, Salogub G, Tidmarsh GF, Gammon GM, Gribben J: Single-agent activity of GCS-100, a first-in-class galectin-3 antagonist, in elderly patients with relapsed chronic lymphocytic leukemia. J Clin Oncol; 2009 May 20;27(15_suppl):7006

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Single-agent activity of GCS-100, a first-in-class galectin-3 antagonist, in elderly patients with relapsed chronic lymphocytic leukemia.
  • GCS-100 has been shown to induce apoptosis of patient CLL cells ex vivo.
  • In addition, GCS-100 potentiates the in vitro activity of other agents commonly used to treat CLL, including rituximab.
  • This phase II clinical trial evaluated the potential of GCS-100 as a novel single-agent therapeutic for relapsed CLL.
  • METHODS: Patients with Rai Stage II or higher CLL who had relapsed after one or two prior therapies were eligible.
  • Prior therapies included a range of chemotherapy combinations including FCR, cyclophosphamide/vincristine/rituximab, and chlorambucil/prednisone.
  • There were no cases of drug-related grade 3 or 4 hematological toxicity or other serious AE.
  • Two patients discontinued treatment due to rash, which resolved with cessation of treatment and which has been shown to be responsive to steroids.
  • CONCLUSIONS: GCS-100 has significant single-agent activity in relapsed CLL.
  • Its lack of myelosuppression and potential synergy with other agents makes GCS-100 a strong candidate for further development in CLL, particularly for elderly patients for whom there is a major need for less toxic agents.

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  • (PMID = 27961378.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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16. Call TG, Constantinou CL, Kahanic SP, Rowland KM, Dakil SR, Hoering A, Li CY, Dewald GW, Kay NE, Witzig TE: NCCTG trial of gemcitabine for relapsed B-cell chronic lymphocytic leukemia. J Clin Oncol; 2004 Jul 15;22(14_suppl):6726

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] NCCTG trial of gemcitabine for relapsed B-cell chronic lymphocytic leukemia.
  • This study was performed to determine the efficacy and toxicity of gemcitabine in B-CLL patients with relapsed disease.
  • METHODS: Patients with relapsed B-CLL and prior treatment with both a purine nucleoside (fludarabine or cladribine) and an alkylating agent were enrolled.
  • Treatment was with gemcitabine (1,000mg/m2) on days 1 and 8 of a 28-day cycle.
  • A two-stage phase II trial design was used to assess the proportion of confirmed responses and toxicities.
  • One patient withdrew prior to treatment and two were deemed ineligible, leaving 19 eligible patients.
  • The median age was 63 years and median prior treatments were 3.
  • Only 6 patients completed the protocol due to: disease progression (8), adverse reaction (3), alternative treatment (2), refusal (1), and death on study (1).
  • The median time to progression was 72 days.
  • Correlative laboratory studies indicated a high risk group of CLL patients entered this protocol.
  • CONCLUSIONS: As a single agent gemcitabine did not show sufficient efficacy in a fludarabine or cladribine pretreated patient cohort of relapsed B cell CLL patients, who also expressed both adverse FISH anomalies and IgVH status.
  • Whether it has a role in more chemotherapy naïve CLL patients, or in combination with other agents, remains to be determined.

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  • (PMID = 28014661.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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17. Köppler H, Heymanns J, Pandorf A, Weide R: Bendamustine plus mitoxantrone--a new effective treatment for advanced chronic lymphocytic leukaemia: results of a phase I/II study. Leuk Lymphoma; 2004 May;45(5):911-3
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  • [Title] Bendamustine plus mitoxantrone--a new effective treatment for advanced chronic lymphocytic leukaemia: results of a phase I/II study.
  • The toxicity arid efficacy of the combination bendamustine plus mitoxantrone (BM) was evaluated in 22 patients with advanced chronic lymphocytic leukaemia (CLL).
  • Six out of twenty-two patients were Binet stage B and 16/22 Binet stage C.
  • The number of courses was limited to six and chemotherapy stopped when a complete remission (CR) or partial remission (PR) according to NCI-Criteria was achieved.
  • Six out of twenty-two patients achieved a CR and 13/22 patients a PR resulting in an overall response rate of 86% (19/22 patients).
  • Median time to progression was 10 months (range 4-22) and median survival 39 months (range 6-50).
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy
  • [MeSH-minor] Aged. Aged, 80 and over. Bendamustine Hydrochloride. Dose-Response Relationship, Drug. Female. Hematologic Diseases / chemically induced. Humans. Male. Middle Aged. Mitoxantrone / administration & dosage. Nitrogen Mustard Compounds / administration & dosage. Opportunistic Infections / chemically induced. Remission Induction. Survival Analysis

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  • (PMID = 15291348.001).
  • [ISSN] 1042-8194
  • [Journal-full-title] Leukemia & lymphoma
  • [ISO-abbreviation] Leuk. Lymphoma
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Nitrogen Mustard Compounds; 981Y8SX18M / Bendamustine Hydrochloride; BZ114NVM5P / Mitoxantrone
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18. Elter T, Borchmann P, Schulz H, Reiser M, Trelle S, Schnell R, Jensen M, Staib P, Schinköthe T, Stützer H, Rech J, Gramatzki M, Aulitzky W, Hasan I, Josting A, Hallek M, Engert A: Fludarabine in combination with alemtuzumab is effective and feasible in patients with relapsed or refractory B-cell chronic lymphocytic leukemia: results of a phase II trial. J Clin Oncol; 2005 Oct 1;23(28):7024-31
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  • [Title] Fludarabine in combination with alemtuzumab is effective and feasible in patients with relapsed or refractory B-cell chronic lymphocytic leukemia: results of a phase II trial.
  • PURPOSE: To determine the efficacy and safety of a newly developed concomitant administration of fludarabine and alemtuzumab (FluCam) in patients with relapsed or refractory B-cell chronic lymphocytic leukemia (B-CLL).
  • PATIENTS AND METHODS: A total of 36 patients were treated in this phase II study (median age, 61.47 years; mean number of prior chemotherapies, 2.6; Binet stage C, n = 28).
  • Treatment was repeated after 28 days for up to six cycles.
  • Restaging (following National Cancer Institute criteria) was carried out after cycles 2 and 4 and 1 month after the end of treatment.
  • Two patients with progressive disease developed fungal pneumonias, and one patient died as a result of Escherichia coli sepsis.
  • CONCLUSION: The new FluCam regimen is effective and feasible in patients with relapsed and refractory B-CLL.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Antibodies, Monoclonal / administration & dosage. Antibodies, Monoclonal, Humanized. Antibodies, Neoplasm / administration & dosage. Drug Resistance, Neoplasm. Female. Humans. Male. Middle Aged. Recurrence. Treatment Outcome. Vidarabine / administration & dosage. Vidarabine / analogs & derivatives

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  • (PMID = 16145065.001).
  • [ISSN] 0732-183X
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antibodies, Monoclonal, Humanized; 0 / Antibodies, Neoplasm; 3A189DH42V / alemtuzumab; FA2DM6879K / Vidarabine; P2K93U8740 / fludarabine
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19. Leporrier M: Role of fludarabine as monotherapy in the treatment of chronic lymphocytic leukemia. Hematol J; 2004;5 Suppl 1:S10-9
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  • [Title] Role of fludarabine as monotherapy in the treatment of chronic lymphocytic leukemia.
  • Fludarabine is a synthetic adenine nucleoside analog that is indicated for first- and second-line treatment of chronic lymphocytic leukemia (CLL).
  • The recommended intravenous (i.v.) dosage regimen is 25 mg/m2 daily for 5 consecutive days, with treatment cycles repeated every 28 days.
  • In treatment-naïve patients with Binet stage B and C CLL, i.v. fludarabine produces superior responses to established first-line chemotherapies.
  • Fludarabine produces a higher overall remission rate (60-70%) and longer progression-free survival (median approximately 20-30 months) than standard therapy with chlorambucil+/-prednisone and CAP (cyclophosphamide/doxorubicin/prednisone), and a comparable overall remission rate to CHOP (cyclophosphamide/vincristine/prednisone/doxorubicin).
  • Fludarabine demonstrates high efficacy in both intermediate-risk (Rai stage I or II) and high-risk (Rai stage III or IV) patients.
  • Fludarabine has significant activity as monotherapy in previously treated CLL, producing objective response rates of up to 94% in typically small-scale, noncomparative studies, with the majority of studies yielding rates of 30-60%.
  • In a phase III multicenter study, the overall remission rate was significantly higher with fludarabine than with CAP (48 versus 27%) among the subset of treatment-refractory patients (n=96).
  • For those patients who are refractory to or have relapsed following conventional chemotherapy (chlorambucil, CAP and CHOP), fludarabine can be considered the treatment of choice for second-line therapy.
  • Moreover, patients with relapsed CLL may benefit from retreatment with fludarabine if they have previously demonstrated sensitivity to the drug.

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  • (PMID = 15079149.001).
  • [ISSN] 1466-4860
  • [Journal-full-title] The hematology journal : the official journal of the European Haematology Association
  • [ISO-abbreviation] Hematol. J.
  • [Language] ENG
  • [Publication-type] Comparative Study; Journal Article; Review
  • [Publication-country] England
  • [Chemical-registry-number] FA2DM6879K / Vidarabine; P2K93U8740 / fludarabine
  • [Number-of-references] 68
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20. Virchis A, Ganeshaguru K, Hart S, Jones D, Fletcher L, Wright F, Wickremasinghe R, Man A, Csermak K, Meyer T, Fabbro D, Champain K, Yap A, Prentice HG, Mehta A: A novel treatment approach for low grade lymphoproliferative disorders using PKC412 (CGP41251), an inhibitor of protein kinase C. Hematol J; 2002;3(3):131-6
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  • [Title] A novel treatment approach for low grade lymphoproliferative disorders using PKC412 (CGP41251), an inhibitor of protein kinase C.
  • We have undertaken a single centre, open-label, multi-dose, exploratory Phase II clinical trial of PKC412 in patients with CLL and low grade NHL.
  • METHODS: Thirteen CLL patients and eight stage IV NHL patients were treated at three oral dose levels of 25, 150 and 225 mg/day for 14 days.
  • RESULTS: There was a median decrease of 29.4% in the lymphocyte count in 11 out of 18 patients with circulating disease following treatment.
  • All returned to normal following cessation of treatment.
  • In 14 out of 20 patients total PKC activity measured in peripheral blood and/or bone marrow lymphocytes was reduced during treatment to a mean of 54% of pre-treatment level.
  • CONCLUSION: PKC412 is safe, well tolerated and reduces the tumor load in chronic B-cell malignancies.
  • Inhibition of PKC offers a novel approach to the chemotherapy of B-cell malignancies.

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  • (PMID = 12111648.001).
  • [ISSN] 1466-4860
  • [Journal-full-title] The hematology journal : the official journal of the European Haematology Association
  • [ISO-abbreviation] Hematol. J.
  • [Language] ENG
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 120685-11-2 / 4'-N-benzoylstaurosporine; EC 2.7.11.13 / Protein Kinase C; H88EPA0A3N / Staurosporine
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21. Kath R, Blumenstengel K, Fricke HJ, Höffken K: Bendamustine monotherapy in advanced and refractory chronic lymphocytic leukemia. J Cancer Res Clin Oncol; 2001 Jan;127(1):48-54
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  • [Title] Bendamustine monotherapy in advanced and refractory chronic lymphocytic leukemia.
  • In an open phase-II study we treated 23 patients with a median age of 62 years at study entry (43-86 years) with advanced, refractory or relapsed (Rai stage III n = 9, Rai stage IV n = 14) chronic lymphocytic leukemia (CLL) with bendamustine.
  • At study entry, only 13 patients were chemotherapy-naive.
  • The treatment schedule with bendamustine was as follows: for patients up to 70 years 60 mg/m2 for 5 days, for patients over 70 years 50 mg/m2 for 5 days, repetition at day 29.
  • An objective remission was achieved in 15/20 patients (75%), including six patients with complete remission (CR).
  • Three of the complete responders had no chemotherapy prior to bendamustine.
  • Median overall survival after bendamustine treatment is 13.6 months (1-46 months) and 16.6 months (1-46 months) in patients responding to bendamustine.
  • Therapy-related anemia and thrombocytopenia were rare.
  • However, WHO grade III/IV leukocytopenia occurred in 38/74 cycles (51%), resulting in treatment-related mortality in 3/23 patients (13%).
  • As a corollary of the study, a general prophylactic antibiotic treatment (trimethoprim/ sulfamerazine) was instituted.
  • A general feature was the decline of the CD4/CD8 ratio: mean before therapy: 1.36; after two courses: 0.98; after four courses: 0.6, as documented in all patients who received at least two courses of bendamustine (n = 12).
  • We observed mainly cutaneous allergic reactions (three WHO grade I; one WHO grade II) leading to a cessation of bendamustine treatment in 4/23 patients (18%).
  • Bendamustine is highly effective in advanced or refractory CLL.
  • [MeSH-major] Alkylating Agents / therapeutic use. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy. Nitrogen Mustard Compounds / therapeutic use
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Antineoplastic Agents, Alkylating / therapeutic use. Bendamustine Hydrochloride. CD4-Positive T-Lymphocytes / drug effects. CD8-Positive T-Lymphocytes / drug effects. Cyclophosphamide / therapeutic use. Female. Humans. Immunophenotyping. Male. Middle Aged. Random Allocation. Time Factors

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  • (PMID = 11206271.001).
  • [ISSN] 0171-5216
  • [Journal-full-title] Journal of cancer research and clinical oncology
  • [ISO-abbreviation] J. Cancer Res. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article
  • [Publication-country] Germany
  • [Chemical-registry-number] 0 / Alkylating Agents; 0 / Antineoplastic Agents, Alkylating; 0 / Nitrogen Mustard Compounds; 8N3DW7272P / Cyclophosphamide; 981Y8SX18M / Bendamustine Hydrochloride
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22. Bosch F, Abrisqueta P, Villamor N, Terol MJ, González-Barca E, Ferra C, González Diaz M, Abella E, Delgado J, Carbonell F, García Marco JA, Escoda L, Ferrer S, Monzó E, González Y, Estany C, Jarque I, Salamero O, Muntañola A, Montserrat E: Rituximab, fludarabine, cyclophosphamide, and mitoxantrone: a new, highly active chemoimmunotherapy regimen for chronic lymphocytic leukemia. J Clin Oncol; 2009 Sep 20;27(27):4578-84
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  • [Title] Rituximab, fludarabine, cyclophosphamide, and mitoxantrone: a new, highly active chemoimmunotherapy regimen for chronic lymphocytic leukemia.
  • PURPOSE: The addition of monoclonal antibodies to chemotherapy has significantly improved treatment of chronic lymphocytic leukemia (CLL).
  • Based on excellent results with the chemotherapy-only regimen fludarabine, cyclophosphamide, and mitoxantrone (FCM), we built a new chemoimmunotherapy combination--rituximab plus FCM (R-FCM).
  • We report a phase II clinical trial consisting of an initial treatment with R-FCM followed by rituximab maintenance.
  • PATIENTS AND METHODS: Seventy-two untreated CLL patients age 70 years or younger received rituximab 500 mg/m(2) on day 1 (375 mg/m(2) the first cycle), fludarabine 25 mg/m(2) IV on days 1 to 3, cyclophosphamide 200 mg/m(2) on days 1 to 3, and mitoxantrone 6 mg/m(2) IV on day 1, given at 4-week intervals with up to six cycles supported with colony-stimulating factor.
  • RESULTS: The overall response, minimal residual disease (MRD) -negative complete response (CR), MRD-positive CR, and partial response rates were 93%, 46%, 36%, and 11%, respectively.
  • Severe neutropenia developed in 13% of patients.
  • Advanced clinical stage, del(17p), or increased serum beta2-microglobulin levels correlated with a lower CR rate.
  • CONCLUSION: R-FCM is highly effective in previously untreated CLL, with an 82% CR rate and a high proportion of MRD-negative CRs (46%).
  • Treatment toxicity is acceptable.
  • Parameters correlating with a lower response rate were advanced clinical stage, high serum beta2-microglobulin levels, and del(17p).
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / administration & dosage. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy

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  • (PMID = 19704063.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Comparative Study; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antibodies, Monoclonal, Murine-Derived; 8N3DW7272P / Cyclophosphamide; BZ114NVM5P / Mitoxantrone; FA2DM6879K / Vidarabine; R-FCM protocol
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23. Chanan-Khan A, Miller KC, Musial L, Lawrence D, Padmanabhan S, Takeshita K, Porter CW, Goodrich DW, Bernstein ZP, Wallace P, Spaner D, Mohr A, Byrne C, Hernandez-Ilizaliturri F, Chrystal C, Starostik P, Czuczman MS: Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase II study. J Clin Oncol; 2006 Dec 1;24(34):5343-9
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  • [Title] Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase II study.
  • PURPOSE: Patients with relapsed or refractory chronic lymphocytic leukemia (CLL) have profound immune defects and limited treatment options.
  • Given the dramatic activity of lenalidomide in other B-cell malignancies and its pleotropic immunomodulatory effects, we conducted a phase II trial of this agent in CLL.
  • PATIENTS AND METHODS: Patients with relapsed or refractory B-cell CLL (B-CLL) were eligible if they required treatment as per the National Cancer Institute Working Group 1996 guidelines.
  • Patients were to continue treatment until disease progression, unacceptable toxicity, or complete remission.
  • Sixty-four percent of the patients had Rai stage III or IV disease, and 51% were refractory to fludarabine.
  • CONCLUSION: Lenalidomide is clinically active in patients with relapsed or refractory B-CLL.
  • These findings are encouraging and warrant further investigation of this agent in the treatment of this disorder.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Immunologic Factors / therapeutic use. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy. Thalidomide / analogs & derivatives
  • [MeSH-minor] Adult. Aged. Fatigue / chemically induced. Female. Humans. Male. Middle Aged. Neoplasm Recurrence, Local / drug therapy. Neutropenia / chemically induced. Remission Induction. Thrombocytopenia / chemically induced


24. Byrd JC, Peterson B, Piro L, Saven A, Vardiman JW, Larson RA, Schiffer C: A phase II study of cladribine treatment for fludarabine refractory B cell chronic lymphocytic leukemia: results from CALGB Study 9211. Leukemia; 2003 Feb;17(2):323-7
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  • [Title] A phase II study of cladribine treatment for fludarabine refractory B cell chronic lymphocytic leukemia: results from CALGB Study 9211.
  • Cladribine has been reported to have little activity in fludarabine- refractory chronic lymphocytic leukemia (CLL).
  • We sought to determine whether resistance to therapy with cladribine in fludarabine-refractory CLL patients represented primary drug resistance or the inability to tolerate the myelosuppression associated with this therapy.
  • Patients with fludarabine refractory CLL patients without severe thrombocytopenia (platelets >/=50 x 10(9)/l) or granulocytopenia (neutrophils >1.5 x 10(9)/l) were enrolled.
  • Patients received up to six cycles of therapy.
  • Twenty-eight patients enrolled; 13 had intermediate (Rai stage I or II) and 15 high (Rai stage III and IV) risk stages.
  • The median time to relapse for responders was 12 months, while median progression-free survival for the entire group was 9 months (95% confidence interval, 4-14 months).
  • Response was predicted by pre-treatment Rai status with seven of 13 (54%) intermediate risk vs two of 15 (13%) high-risk patients responding (P = 0.04).
  • Cladribine has modest clinical activity and considerable toxicity in a very selected group of patients with fludarabine-refractory CLL lacking pre-treatment neutropenia and thrombocytopenia.
  • [MeSH-major] Cladribine / therapeutic use. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy. Vidarabine / adverse effects. Vidarabine / analogs & derivatives
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Antineoplastic Agents / administration & dosage. Antineoplastic Agents / adverse effects. Antineoplastic Agents / therapeutic use. Confidence Intervals. Disease-Free Survival. Drug Administration Schedule. Drug Resistance, Neoplasm. Humans. Infusions, Intravenous. Middle Aged. Neoplasm Staging. Patient Selection. Survival Rate. Time Factors

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  • (PMID = 12592330.001).
  • [ISSN] 0887-6924
  • [Journal-full-title] Leukemia
  • [ISO-abbreviation] Leukemia
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / CA03927; United States / NCI NIH HHS / CA / CA04457; United States / NCI NIH HHS / CA / CA07968; United States / NCI NIH HHS / CA / CA11789; United States / NCI NIH HHS / CA / CA16450; United States / NCI NIH HHS / CA / CA21060; United States / NCI NIH HHS / CA / CA31946; United States / NCI NIH HHS / CA / CA31983; United States / NCI NIH HHS / CA / CA32291; United States / NCI NIH HHS / CA / CA33601; United States / NCI NIH HHS / CA / CA35279; United States / NCI NIH HHS / CA / CA41287; United States / NCI NIH HHS / CA / CA45389; United States / NCI NIH HHS / CA / CA45808; United States / NCI NIH HHS / CA / CA47555; United States / NCI NIH HHS / CA / CA47559; United States / NCI NIH HHS / CA / CA47577; United States / NCI NIH HHS / CA / CA47642; United States / NCI NIH HHS / CA / CA77440
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 47M74X9YT5 / Cladribine; FA2DM6879K / Vidarabine; P2K93U8740 / fludarabine
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25. Biswas G, Parikh PM, Nair R, Bhagwat R, Bakshi A, Prabhash K, Vora A, Gupta S, Pai VR, Menon H, Sastry PS: Rituximab (anti-CD20 monoclonal antibody) in lymphoproliferative malignancies: Tata Memorial experience. J Assoc Physicians India; 2006 Jan;54:29-33
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  • The histology was aggressive NHL in 35, indolent NHL in 22 and 7 cases were diagnosed as CLL.
  • Among NHL, sixteen were in early stage (I/II) and the remaining forty-one were in advanced stage (III/IV) of disease.
  • A total of 33 were de novo cases and 31 were previously treated.
  • Rituximab was used in combination with chemotherapy in the other 47 cases.
  • The patient who developed anaphylaxis required discontinuation of further Rituximab.
  • The overall RR (CR + PR) was 72%.
  • A total of seven patients died, three due to progressive disease, three due to chemotherapy related toxicity and one due to an unrelated cause.
  • We conclude that Rituximab is a valuable addition to the treatment armamentarium of lymphoproliferative disorders.
  • [MeSH-major] Antibodies, Monoclonal / therapeutic use. Antigens, CD20 / drug effects. Antineoplastic Agents / therapeutic use. Lymphoma, Non-Hodgkin / drug therapy
  • [MeSH-minor] Adolescent. Adult. Aged. Aged, 80 and over. Antibodies, Monoclonal, Murine-Derived. Disease Progression. Female. Humans. India. Male. Middle Aged. Proto-Oncogene Proteins c-bcl-2 / drug effects. Retrospective Studies. Rituximab. Survival Rate

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  • (PMID = 16649735.001).
  • [ISSN] 0004-5772
  • [Journal-full-title] The Journal of the Association of Physicians of India
  • [ISO-abbreviation] J Assoc Physicians India
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] India
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antibodies, Monoclonal, Murine-Derived; 0 / Antigens, CD20; 0 / Antineoplastic Agents; 0 / Proto-Oncogene Proteins c-bcl-2; 4F4X42SYQ6 / Rituximab
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26. Paydas S, Tanriverdi K, Yavuz S, Seydaoglu G: PRAME mRNA levels in cases with chronic leukemia: Clinical importance and review of the literature. Leuk Res; 2007 Mar;31(3):365-9
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  • [Title] PRAME mRNA levels in cases with chronic leukemia: Clinical importance and review of the literature.
  • Preferentially expressed antigen of melanoma (PRAME) is a tumor antigen expressed in various malignant tumors including solid tumors and hemopoietic neoplasias but no or weak expression in normal tissues.
  • The aim of this study is to determine the frequency and the clinical importance of PRAME expression in chronic myeloid leukemia (CML)/chronic myeloproliferative disorders (CMPD) and chronic lymphocytic leukemia (CLL).
  • PRAME mRNA was measured by real time RT-PCR in 88 cases with chronic leukemia (CL) and 42 controls.
  • Seventy cases had CML/CMPD (56 had chronic phase (CP)-14 had accelerated/blastic phase disease (AP/BP) and 18 cases had CLL (11 had early stage (Rai 0-I-II) and 7 had late stage (Rai III-IV).
  • Twenty-four of 70 (34%) cases with CML/CMPD and 5 of 18 (28%) cases with CLL showed PRAME expression.
  • PRAME (+) and PRAME (-) cases were not different for age, Hb, Hct, WBC count, platelet count, stage of the disease and response to therapy.
  • PRAME was monitorised in eight cases during follow-up: in three cases PRAME was negative at CP and expression developed at the AP/BP disease.
  • PRAME was positive at the beginning in five cases (4 CML-1CLL) and expression disappeared after chemotherapy.
  • PRAME mRNA changes may be detected during the progression of these disorders and/or after therapy.
  • PRAME mRNA may be a useful marker to detect the minimal residual disease (MRD) and to determine the response to therapy in CLs.
  • [MeSH-major] Antigens, Neoplasm / genetics. Biomarkers, Tumor / genetics. Leukemia, Lymphocytic, Chronic, B-Cell / genetics. Leukemia, Myelogenous, Chronic, BCR-ABL Positive / genetics. Myeloproliferative Disorders / genetics. RNA, Messenger / genetics
  • [MeSH-minor] Adolescent. Adult. Aged. Aged, 80 and over. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Chronic Disease. Disease Progression. Female. Follow-Up Studies. Gene Expression Profiling. Humans. Male. Middle Aged. Neoplasm Staging. Reverse Transcriptase Polymerase Chain Reaction / methods. Treatment Outcome

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  • (PMID = 16914202.001).
  • [ISSN] 0145-2126
  • [Journal-full-title] Leukemia research
  • [ISO-abbreviation] Leuk. Res.
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antigens, Neoplasm; 0 / Biomarkers, Tumor; 0 / PRAME protein, human; 0 / RNA, Messenger
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27. Morrison VA, Rai KR, Peterson BL, Kolitz JE, Elias L, Appelbaum FR, Hines JD, Shepherd L, Larson RA, Schiffer CA: Therapy-related myeloid leukemias are observed in patients with chronic lymphocytic leukemia after treatment with fludarabine and chlorambucil: results of an intergroup study, cancer and leukemia group B 9011. J Clin Oncol; 2002 Sep 15;20(18):3878-84
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  • [Title] Therapy-related myeloid leukemias are observed in patients with chronic lymphocytic leukemia after treatment with fludarabine and chlorambucil: results of an intergroup study, cancer and leukemia group B 9011.
  • PURPOSE: Patients with chronic lymphocytic leukemia (CLL) may have disease transformation to non-Hodgkin's lymphoma or prolymphocytic leukemia; however, development of therapy-related acute myeloid leukemia (t-AML) is unusual.
  • A series of patients enrolled onto an intergroup CLL trial were examined for this complication.
  • PATIENTS AND METHODS: A total of 544 previously untreated B-cell CLL patients were enrolled onto a randomized intergroup study comparing treatment with chlorambucil, fludarabine, or fludarabine plus chlorambucil.
  • RESULTS: With a median follow-up of 4.2 years, six patients (1.2%) to date have developed therapy-related myelodysplastic syndrome (t-MDS; n = 3), t-AML (n = 2), or t-MDS evolving to t-AML (n = 1), from 27 to 53 months (median, 34 months) after study entry.
  • This included five (3.5%) of 142 patients treated with fludarabine plus chlorambucil and one (0.5%) of 188 receiving fludarabine; no chlorambucil-treated patients developed t-MDS or t-AML (P =.007).
  • At study entry, the median age among these six patients was 56 years (range, 44 to 72 years); three were male; the CLL Rai stage was I/II (n = 4) or III/IV (n = 2).
  • Response to CLL therapy was complete (n = 4) or partial remission (n = 1) and stable disease (n = 1).
  • CONCLUSION: Our findings raise the possibility that alkylator-purine analog combination therapy may increase the risk of therapy-related myeloid malignancies, which is of particular relevance with regard to ongoing trials using these combination therapies.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / adverse effects. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy. Leukemia, Myeloid / chemically induced. Myelodysplastic Syndromes / chemically induced. Neoplasms, Second Primary / chemically induced

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  • [CommentIn] J Clin Oncol. 2003 Oct 1;21(19):3709; author reply 3709-10 [14512411.001]
  • (PMID = 12228208.001).
  • [ISSN] 0732-183X
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / CA21115; United States / NCI NIH HHS / CA / CA31946; United States / NCI NIH HHS / CA / CA32102
  • [Publication-type] Clinical Trial; Controlled Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 18D0SL7309 / Chlorambucil; FA2DM6879K / Vidarabine; P2K93U8740 / fludarabine
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28. Rieger K, Von Grünhagen U, Fietz T, Thiel E, Knauf W: Efficacy and tolerability of alemtuzumab (CAMPATH-1H) in the salvage treatment of B-cell chronic lymphocytic leukemia--change of regimen needed? Leuk Lymphoma; 2004 Feb;45(2):345-9
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  • [Title] Efficacy and tolerability of alemtuzumab (CAMPATH-1H) in the salvage treatment of B-cell chronic lymphocytic leukemia--change of regimen needed?
  • We report on the response rate and tolerability of Alemtuzumab (Campath-1H) in a series of heavily pretreated patients with B-CLL with a special focus on treatment-related problems.
  • Thirteen patients with B-chronic lymphocytic leukemia (B-CLL), 1 prolymphocytic leukemia (PLL), 1 mantle cell lymphoma (MCL) and 1 leukemic immunocytoma (IC) transformed into a high-grade NHL were included.
  • All patients received 3, 10 and 30 mg of Campath-1H on sequential days, and then were subsequently scheduled for 30 mg 3 times weekly.
  • One patient attained complete remission (CR), 8 patients achieved partial remission (PR), while 4 patients had stable disease (SD).
  • Beginning with initiation of treatment recurrent profound leukopenia became evident in 13 out of 16 patients leading to treatment discontinuation.
  • Therefore, we developed a steroid co-medication regimen for the first 4 Campath-1H applications with quick tapering thereafter.
  • Following this regimen, no infusion associated side effects WHO grade > II were observed.
  • Infectious complications leading to treatment discontinuation consisted of pulmonary aspergillosis in one and bacterial pneumonia in another case.
  • One patient with refractory B-CLL and Pneumocystis carinii pneumonia plus CMV reactivation died.
  • In summary, Campath-1H appears to be effective against leukemic low-grade B-NHL, also in advanced stage.
  • In our series, application 3 times weekly was not possible due to hematotoxicity.
  • We recommend, therefore, flexible time intervals depending on the leukocyte counts.
  • [MeSH-major] Antibodies, Monoclonal / therapeutic use. Antibodies, Neoplasm / therapeutic use. Antineoplastic Agents / therapeutic use. Leukemia, B-Cell / drug therapy. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy. Salvage Therapy
  • [MeSH-minor] Adult. Aged. Antibodies, Monoclonal, Humanized. Antigens, CD / biosynthesis. Antigens, Neoplasm / biosynthesis. Female. Glycoproteins / biosynthesis. Humans. Male. Middle Aged. Remission Induction. Steroids / therapeutic use. Time Factors. Treatment Outcome

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  • (PMID = 15101722.001).
  • [ISSN] 1042-8194
  • [Journal-full-title] Leukemia & lymphoma
  • [ISO-abbreviation] Leuk. Lymphoma
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antibodies, Monoclonal, Humanized; 0 / Antibodies, Neoplasm; 0 / Antigens, CD; 0 / Antigens, Neoplasm; 0 / Antineoplastic Agents; 0 / CD52 antigen; 0 / Glycoproteins; 0 / Steroids; 3A189DH42V / alemtuzumab
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29. Nemets A, Ben Dor D, Barry T, Ducach A, Blumental R, Ben Alon D, Lugassy G: Variant Richter's syndrome: a rare case of classical Hodgkin's lymphoma developing in a patient with chronic lymphocytic leukemia treated with fludarabine. Leuk Lymphoma; 2003 Dec;44(12):2151-4
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  • [Title] Variant Richter's syndrome: a rare case of classical Hodgkin's lymphoma developing in a patient with chronic lymphocytic leukemia treated with fludarabine.
  • We report a case of a 52-year-old male who developed classical Hodgkin's lymphoma (HL) four years after diagnosis of stage Rai II (Binet B) chronic lymphocytic leukemia (CLL).
  • An inguinal lymph node biopsy revealed both classical Hodgkin's lymphoma, nodular sclerosing type grade 2 and CLL.
  • A bone marrow biopsy showed no Reed-Steinberg cells and an infiltrate composed of only scattered small lymphocytes consistent with CLL.
  • Immuno-histochemical studies of the lymph node were consistent with both CLL and HL phenotypes.
  • Treatment with MOPP/ABVD was started and fever subsided within 3 days.
  • Our case is one of the very few descriptions of a rare Richter's variant of CLL with progression to HL in a CLL patient treated with fludarabine.
  • Since fludarabine has become standard therapy in CLL such Richter's variant could be the result of therapy, an induced prolonged and severe immunosuppression.
  • Clinicians should be aware of such association, which could become more frequent among CLL patients treated with purine analogs.
  • [MeSH-major] Hodgkin Disease / diagnosis. Hodgkin Disease / pathology. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy. Neoplasms, Second Primary / diagnosis. Neoplasms, Second Primary / pathology. Vidarabine / analogs & derivatives. Vidarabine / therapeutic use
  • [MeSH-minor] Antineoplastic Agents / therapeutic use. Antineoplastic Agents, Alkylating / therapeutic use. Biopsy. Bone Marrow / pathology. Cyclophosphamide / therapeutic use. Disease Progression. Humans. Lymph Nodes / pathology. Lymphatic Metastasis. Male. Middle Aged. Syndrome. Time Factors

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  • (PMID = 14959863.001).
  • [ISSN] 1042-8194
  • [Journal-full-title] Leukemia & lymphoma
  • [ISO-abbreviation] Leuk. Lymphoma
  • [Language] eng
  • [Publication-type] Case Reports; Journal Article
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Antineoplastic Agents, Alkylating; 8N3DW7272P / Cyclophosphamide; FA2DM6879K / Vidarabine; P2K93U8740 / fludarabine
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30. Coiffier B, Lepretre S, Pedersen LM, Gadeberg O, Fredriksen H, van Oers MH, Wooldridge J, Kloczko J, Holowiecki J, Hellmann A, Walewski J, Flensburg M, Petersen J, Robak T: Safety and efficacy of ofatumumab, a fully human monoclonal anti-CD20 antibody, in patients with relapsed or refractory B-cell chronic lymphocytic leukemia: a phase 1-2 study. Blood; 2008 Feb 1;111(3):1094-100
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Safety and efficacy of ofatumumab, a fully human monoclonal anti-CD20 antibody, in patients with relapsed or refractory B-cell chronic lymphocytic leukemia: a phase 1-2 study.
  • Safety and efficacy of the fully human anti-CD20 monoclonal antibody, ofatumumab, was analyzed in a multicenter dose-escalating study including 33 patients with relapsed or refractory chronic lymphocytic leukemia.
  • Sixty-seven percent of the patients were Binet stage B, and the median number of previous treatments was 3.
  • In conclusion, ofatumumab was found to be well tolerated in patients with chronic lymphocytic leukemia (CLL) in doses up to 2000 mg.
  • Preliminary data on safety and objective response are encouraging and support further studies on the role of ofatumumab in CLL patients.
  • [MeSH-major] Antibodies, Monoclonal / adverse effects. Antibodies, Monoclonal / therapeutic use. Antigens, CD20 / immunology. Drug-Related Side Effects and Adverse Reactions. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy. Leukemia, Lymphocytic, Chronic, B-Cell / immunology
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Cohort Studies. Female. Humans. Immunotherapy. Male. Middle Aged. Recurrence. Time Factors


31. Shanafelt TD, Lee YK, Call TG, Nowakowski GS, Dingli D, Zent CS, Kay NE: Clinical effects of oral green tea extracts in four patients with low grade B-cell malignancies. Leuk Res; 2006 Jun;30(6):707-12
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  • We previously reported the in vitro ability of one tea polyphenol, epigallocatechin gallate (EGCG), to induce apoptotic cell death in the leukemic B-cells from a majority of patients with chronic lymphocytic leukemia (CLL).
  • After the publication of our findings many patients with CLL and other low grade lymphomas began using over-the-counter products containing tea polyphenols despite the absence of evidence to suggest clinical benefit, definition of possible toxicities, or information on optimal dose and schedule.
  • Several patients presented here had documented steady clinical, laboratory, and/or radiographic evidence of progression immediately prior to initiation of over-the-counter green tea products and then developed objective responses shortly after self-initiating this therapy.
  • An NCI sponsored phase I/II trial of de-caffeinated green tea extracts for patients with asymptomatic, early stage CLL opened at Mayo Clinic in August 2005.
  • [MeSH-major] Anticarcinogenic Agents / therapeutic use. Camellia sinensis. Catechin / analogs & derivatives. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy. Phytotherapy

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  • [CommentIn] Leuk Res. 2006 Jun;30(6):649-50 [16337269.001]
  • (PMID = 16325256.001).
  • [ISSN] 0145-2126
  • [Journal-full-title] Leukemia research
  • [ISO-abbreviation] Leuk. Res.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / CA95241; United States / NCI NIH HHS / CA / CA95241-S; United States / NCI NIH HHS / CA / CA97274
  • [Publication-type] Case Reports; Journal Article; Research Support, N.I.H., Extramural
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Anticarcinogenic Agents; 0 / Plant Extracts; 0 / Tea; 8R1V1STN48 / Catechin; BQM438CTEL / epigallocatechin gallate
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32. McBride NC, Cavenagh JD, Ward MC, Grant I, Schey S, Gray A, Hughes A, Mills MJ, Cervi P, Newland AC, Kelsey SM: Liposomal daunorubicin (DaunoXome) in combination with cyclophosphamide, vincristine and prednisolone (COP-X) as salvage therapy in poor-prognosis non-Hodgkins lymphoma. Leuk Lymphoma; 2001 Jun;42(1-2):89-98
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  • [Title] Liposomal daunorubicin (DaunoXome) in combination with cyclophosphamide, vincristine and prednisolone (COP-X) as salvage therapy in poor-prognosis non-Hodgkins lymphoma.
  • Eighteen subjects had relapsed/refractory aggressive NHL and 15 had indolent NHL/CLL.
  • 88% of patients with aggressive NHL responded; three (18%) patients achieved complete remission (CR), 12 (70%) achieved partial remission (PR), 1 (6%) patient had stable disease (SD) and 1 (6%) patient progressed through treatment.
  • The response rate in indolent NHL/CLL was 73%.
  • Four (27%) patients achieved CR, 7 (46%) PR and 4 (27%) SD.
  • At two years post treatment, 55% of the patients with indolent NHL/CLL remain progression-free, although 4 patients have proceeded to consolidation therapy.
  • Twenty-seven out of 28 (96%) patients developed neutropenia of short duration following one or more of their treatments.
  • Twenty-three patients developed an infection at some stage during therapy (all associated with neutropenia) and required hospitalisation.
  • Platelet toxicity was mild in patients with normal platelet counts at the commencement of therapy.
  • [MeSH-major] Antibiotics, Antineoplastic / administration & dosage. Antineoplastic Combined Chemotherapy Protocols / administration & dosage. Daunorubicin / administration & dosage. Lymphoma, Non-Hodgkin / drug therapy. Salvage Therapy / methods
  • [MeSH-minor] Aged. Cyclophosphamide / administration & dosage. Female. Humans. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy. Liposomes / administration & dosage. Male. Middle Aged. Prednisolone / administration & dosage. Prognosis. Remission Induction. Survival Analysis. Therapeutic Equivalency. Treatment Outcome. Vincristine / administration & dosage

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  • (PMID = 11699226.001).
  • [ISSN] 1042-8194
  • [Journal-full-title] Leukemia & lymphoma
  • [ISO-abbreviation] Leuk. Lymphoma
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] Switzerland
  • [Chemical-registry-number] 0 / Antibiotics, Antineoplastic; 0 / Liposomes; 5J49Q6B70F / Vincristine; 8N3DW7272P / Cyclophosphamide; 9PHQ9Y1OLM / Prednisolone; ZS7284E0ZP / Daunorubicin
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33. Byrd JC, Peterson BL, Gabrilove J, Odenike OM, Grever MR, Rai K, Larson RA, Cancer and Leukemia Group B: Treatment of relapsed chronic lymphocytic leukemia by 72-hour continuous infusion or 1-hour bolus infusion of flavopiridol: results from Cancer and Leukemia Group B study 19805. Clin Cancer Res; 2005 Jun 1;11(11):4176-81
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  • [Title] Treatment of relapsed chronic lymphocytic leukemia by 72-hour continuous infusion or 1-hour bolus infusion of flavopiridol: results from Cancer and Leukemia Group B study 19805.
  • PURPOSE: Flavopiridol has in vitro activity in chronic lymphocytic leukemia (CLL) and promotes apoptosis independent of p53 function or prior fludarabine exposure.
  • We sought to determine if flavopiridol has activity in previously treated CLL using two schedules of administration.
  • PATIENTS AND METHODS: Patients with previously treated CLL were enrolled in two sequentially done phase II studies.
  • Patients received up to 12 (CI cohort) or 8 (IVB cohort) cycles of therapy.
  • RESULTS: Fifteen patients were enrolled in the 72-hour CI phase II trial; 6 (40%) had intermediate-risk (Rai stage I or II) and 9 (60%) had high-risk (Rai stage III and IV) stages.
  • CONCLUSIONS: Flavopiridol has modest, schedule-dependent clinical activity in relapsed CLL and warrants future investigation utilizing alternative schedules of administration.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Flavonoids / therapeutic use. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy. Piperidines / therapeutic use
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Drug Administration Schedule. Female. Humans. Infusion Pumps. Male. Middle Aged. Neoplasm Recurrence, Local. Neoplasm Staging. Neutropenia / chemically induced. Survival Analysis. Thrombocytopenia / chemically induced. Treatment Outcome

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  • [CommentIn] Clin Cancer Res. 2005 Jun 1;11(11):3971-3 [15930331.001]
  • (PMID = 15930354.001).
  • [ISSN] 1078-0432
  • [Journal-full-title] Clinical cancer research : an official journal of the American Association for Cancer Research
  • [ISO-abbreviation] Clin. Cancer Res.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / CA31946
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Comparative Study; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Flavonoids; 0 / Piperidines; 45AD6X575G / alvocidib
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34. Balakrishnan K, Verma D, O'Brien S, Kilpatrick JM, Chen Y, Tyler BF, Bickel S, Bantia S, Keating MJ, Kantarjian H, Gandhi V, Ravandi F: Phase 2 and pharmacodynamic study of oral forodesine in patients with advanced, fludarabine-treated chronic lymphocytic leukemia. Blood; 2010 Aug 12;116(6):886-92
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  • [Title] Phase 2 and pharmacodynamic study of oral forodesine in patients with advanced, fludarabine-treated chronic lymphocytic leukemia.
  • Patients with chronic lymphocytic leukemia (CLL) with primary resistance to fludarabine-based therapy or with progressive disease were eligible for oral forodesine (200 mg/d) for up to 24 weeks.
  • Six had Rai stage III to IV and were previously heavily treated (median prior therapy = 5).
  • Compared with in vivo, in vitro incubations of CLL lymphocytes with 10 or 20 microM dGuo and forodesine (2 microM) resulted in accumulation of higher levels of dGTP (40-250 microM) which resulted in increase in apoptosis.
  • Forodesine has biologic activity in CLL; pharmacodynamic parameters suggest that an alternate dosing schedule and/or higher doses to achieve greater intracellular dGTP may be beneficial in this patient population.
  • [MeSH-major] Enzyme Inhibitors / administration & dosage. Enzyme Inhibitors / pharmacokinetics. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy. Purine Nucleosides / administration & dosage. Purine Nucleosides / pharmacokinetics. Pyrimidinones / administration & dosage. Pyrimidinones / pharmacokinetics. Vidarabine / analogs & derivatives
  • [MeSH-minor] Administration, Oral. Aged. Antineoplastic Agents / administration & dosage. Apoptosis / drug effects. Drug Administration Schedule. Drug Therapy, Combination. Female. Follow-Up Studies. Humans. Lymphocyte Count. Lymphocytes / cytology. Lymphocytes / drug effects. Male. Middle Aged. Phosphoric Monoester Hydrolases / metabolism. Purine-Nucleoside Phosphorylase / antagonists & inhibitors. Purine-Nucleoside Phosphorylase / metabolism. Severity of Illness Index

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  • (PMID = 20427701.001).
  • [ISSN] 1528-0020
  • [Journal-full-title] Blood
  • [ISO-abbreviation] Blood
  • [Language] eng
  • [Databank-accession-numbers] ClinicalTrials.gov/ NCT00289549
  • [Grant] United States / NCI NIH HHS / CA / P01 CA081534; United States / NCI NIH HHS / CA / P30 CA016672; United States / NCI NIH HHS / CA / CA81534; United States / PHS HHS / / P30-16672
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Enzyme Inhibitors; 0 / Purine Nucleosides; 0 / Pyrimidinones; 426X066ELK / forodesine; EC 2.4.2.1 / Purine-Nucleoside Phosphorylase; EC 3.1.3.2 / Phosphoric Monoester Hydrolases; FA2DM6879K / Vidarabine; P2K93U8740 / fludarabine
  • [Other-IDs] NLM/ PMC2924226
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35. Vener C, Gianelli U, Cortelezzi A, Fracchiolla NS, Somalvico F, Savi F, Pasquini MC, Bosari S, Deliliers GL: ZAP-70 immunoreactivity is a prognostic marker of disease progression in chronic lymphocytic leukemia. Leuk Lymphoma; 2006 Feb;47(2):245-51
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] ZAP-70 immunoreactivity is a prognostic marker of disease progression in chronic lymphocytic leukemia.
  • The expression of zeta-associated protein 70 (ZAP-70) in chronic lymphocytic leukemia (CLL) seems to correlate with the mutational status of the immunoglobulin heavy-chain variable-region genes, clinical course and patient prognosis.
  • The aim was to determine the prognostic significance of the immunohistochemical expression of ZAP-70 protein in CLL by means of the long-term follow-up of 108 patients.
  • Overall, ZAP-70 immunoreactivity correlated with an abnormal karyotype ( p = 0.017), a lymphocyte doubling time (LDT) of <6 months ( p = 0.001) and <12 months ( p = 0.01), Rai II - IV and Binet B - C stage ( p = 0.013), the clinical need for chemotherapy ( p < 0.001) and the need for more than 1 chemotherapy line ( p < 0.001).
  • Kaplan-Meier analysis demonstrated that ZAP-70 immunoreactivity closely correlated with a shorter LDT ( p < 0.0001) and time from diagnosis to initial therapy ( p = 0.0001).
  • This study shows that ZAP-70 immunoreactivity can be a reliable prognostic marker in CLL and proposes a system for evaluating the results.
  • The observations support the inclusion of the immunohistochemical expression of ZAP-70 in clinical trials involving CLL patients.
  • [MeSH-major] Leukemia, Lymphocytic, Chronic, B-Cell / metabolism. ZAP-70 Protein-Tyrosine Kinase / metabolism

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  • (PMID = 16321853.001).
  • [ISSN] 1042-8194
  • [Journal-full-title] Leukemia & lymphoma
  • [ISO-abbreviation] Leuk. Lymphoma
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article
  • [Publication-country] England
  • [Chemical-registry-number] EC 2.7.10.2 / ZAP-70 Protein-Tyrosine Kinase; EC 2.7.10.2 / ZAP70 protein, human
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36. Wang ML, Shih LY, Dunn P, Kuo MC: Meningeal involvement in B-cell chronic lymphocytic leukemia: report of two cases. J Formos Med Assoc; 2000 Oct;99(10):775-8
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Meningeal involvement in B-cell chronic lymphocytic leukemia: report of two cases.
  • Symptomatic central nervous system (CNS) involvement in chronic lymphocytic leukemia (CLL) or its variants is rare.
  • We report two cases of CLL with leptomeningeal involvement.
  • Patient one was an 81-year-old male who had CLL stage C (IV) at diagnosis and developed meningeal disease 29 months later.
  • Patient 2 was a 42-year-old male with a diagnosis of CLL stage A (II) that evolved into mixed-cell CLL/prolymphocytic leukemia (PLL) 1.5 years later, with leptomeningeal infiltration of prolymphocytes developing 26 months after initial diagnosis.
  • Meningeal leukemia was diagnosed by cerebrospinal fluid examination, with flow cytometry showing the same immunophenotypic findings of lambda-light chain restriction as the lymphocytes in bone marrow in one patient, and with morphologic characteristics exhibiting exclusively prolymphocytes in the other patient.
  • The CNS disease of both patients responded effectively to intrathecal chemotherapy and cranial irradiation.
  • However, both patients died of infection, a major cause of morbidity and mortality in patients with CLL.
  • The clinicopathologic features of these two patients indicate that, despite the rarity of CNS involvement in CLL patients, any neurologic manifestation in CLL patients should arouse suspicion of meningeal leukemia and patients should be examined and managed accordingly.

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  • (PMID = 11061073.001).
  • [ISSN] 0929-6646
  • [Journal-full-title] Journal of the Formosan Medical Association = Taiwan yi zhi
  • [ISO-abbreviation] J. Formos. Med. Assoc.
  • [Language] ENG
  • [Publication-type] Case Reports; Journal Article
  • [Publication-country] Singapore
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37. Weide R, Heymanns J, Gores A, Köppler H: Bendamustine mitoxantrone and rituximab (BMR): a new effective regimen for refractory or relapsed indolent lymphomas. Leuk Lymphoma; 2002 Feb;43(2):327-31
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • Bendamustine (B) and mitoxantrone (M) have been shown to be potent cytotoxic drugs for the treatment of relapsed or refractory indolent lymphomas.
  • This study was an open label, single center pilot study for patients with relapsed or refractory, CD20-positive (indolent) lymphoma or chronic lymphocytic leukaemia.
  • The therapy consisted of bendamustine (80 mg/m2, day 1-3), mitoxantrone (10 mg/m2, day 1), rituximab (375 mg/m2, week 2-5).
  • The maximum therapy consisted of one BMR-cycle, followed by five BM courses.
  • Treatment was stopped when the disease responded with PR/CR.
  • During March 1999 and December 2000, 20 patients received the BMR-regimen (four secondary high grade lymphoma, 12 indolent lymphoma, four B-CLL).
  • Median number of previous treatment regimens was two (1-6).
  • Of the lymphoma patients, 14 had stage IV disease, 1 stage III and 1 stage II.
  • B-CLL patients were all Rai stage IV (Binet C).
  • Overall response rate was 95% (19/20) with seven patients achieving a CR (35%) and 12 patients achieving a PR (60%).
  • Median time to progression is 7 months (1-21) with a median observation time of 7 months (1-21).
  • Response is still durable in 15/20 patients (75%) (1+ to 21+ months after therapy).
  • In conclusion, BMR is a well tolerated, very effective outpatient regimen of treatment for relapsed and refractory indolent lymphoid malignancies.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / administration & dosage. Lymphoma, B-Cell / drug therapy
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Antibodies, Monoclonal / administration & dosage. Antibodies, Monoclonal, Murine-Derived. Bendamustine Hydrochloride. Disease-Free Survival. Humans. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy. Middle Aged. Mitoxantrone / administration & dosage. Nitrogen Mustard Compounds / administration & dosage. Remission Induction. Rituximab. Salvage Therapy

  • Hazardous Substances Data Bank. Bendamustine .
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  • (PMID = 11999564.001).
  • [ISSN] 1042-8194
  • [Journal-full-title] Leukemia & lymphoma
  • [ISO-abbreviation] Leuk. Lymphoma
  • [Language] eng
  • [Publication-type] Clinical Trial; Journal Article
  • [Publication-country] Switzerland
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antibodies, Monoclonal, Murine-Derived; 0 / Nitrogen Mustard Compounds; 4F4X42SYQ6 / Rituximab; 981Y8SX18M / Bendamustine Hydrochloride; BZ114NVM5P / Mitoxantrone
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38. Kay NE, Wu W, Kabat B, LaPlant B, Lin TS, Byrd JC, Jelinek DF, Grever MR, Zent CS, Call TG, Shanafelt TD: Pentostatin and rituximab therapy for previously untreated patients with B-cell chronic lymphocytic leukemia. Cancer; 2010 May 1;116(9):2180-7
Hazardous Substances Data Bank. PENTOSTATIN .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Pentostatin and rituximab therapy for previously untreated patients with B-cell chronic lymphocytic leukemia.
  • BACKGROUND: The combination of pentostatin (P), cyclophosphamide (C), and rituximab (R) achieved an overall response (OR) rate >90%, with >40% complete responses (CRs) in patients with untreated chronic lymphocytic leukemia (CLL).
  • Among the 33 patients enrolled, 82% were male, the median age was 65 years (9 patients were aged >or=70 years), and 64% were classified as having Rai stage III to IV disease.
  • At the time of last follow-up, 29 of 33 patients were still alive at a median follow-up of 14 months (range, 1-34.8 months).
  • Comparison of this trial with the previous PCR trial demonstrated that patients treated with PCR had a higher OR rate (91% vs 76%) and CR rate (41% vs 27%) compared with patients treated with PR.
  • The median treatment-free survival for all accrued patients was notably longer in patients treated with PCR compared with PR (30 months vs 16 months).
  • CONCLUSIONS: The findings of the current study suggest that increasing the dose of the purine nucleoside analogue does not eliminate the need for cyclophosphamide in chemoimmunotherapy for the treatment of CLL.

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  • [Copyright] (c) 2010 American Cancer Society.
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  • (PMID = 20187101.001).
  • [ISSN] 0008-543X
  • [Journal-full-title] Cancer
  • [ISO-abbreviation] Cancer
  • [Language] ENG
  • [Grant] United States / NCRR NIH HHS / RR / M01 RR000585; United States / NCRR NIH HHS / RR / M01 RR000585-332094; United States / NCI NIH HHS / CA / CA095241-09; United States / NCI NIH HHS / CA / CA95241; United States / NCI NIH HHS / CA / CA113408; United States / NCI NIH HHS / CA / R01 CA095241-09; United States / NCI NIH HHS / CA / R01 CA136591; United States / NCRR NIH HHS / RR / RR000585-332094; United States / NCI NIH HHS / CA / K23 CA113408; United States / NCI NIH HHS / CA / R01 CA095241
  • [Publication-type] Clinical Trial, Phase II; Comparative Study; Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antibodies, Monoclonal, Murine-Derived; 395575MZO7 / Pentostatin; 4F4X42SYQ6 / Rituximab; 8N3DW7272P / Cyclophosphamide
  • [Other-IDs] NLM/ NIHMS219527; NLM/ PMC2919331
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