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1. 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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2. Stilgenbauer S, Sander S, Bullinger L, Benner A, Leupolt E, Winkler D, Kröber A, Kienle D, Lichter P, Döhner H: Clonal evolution in chronic lymphocytic leukemia: acquisition of high-risk genomic aberrations associated with unmutated VH, resistance to therapy, and short survival. Haematologica; 2007 Sep;92(9):1242-5
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  • [Title] Clonal evolution in chronic lymphocytic leukemia: acquisition of high-risk genomic aberrations associated with unmutated VH, resistance to therapy, and short survival.
  • In chronic lymphocytic leukemia (CLL), the acquisition of new genomic aberrations during the disease course (clonal evolution) is thought to be an infrequent phenomenon but comprehensive analyses are limited.
  • Genomic aberrations were analyzed by fluorescence in situ hybridization (FISH) at various time points during the disease course of 64 CLL patients.
  • Following a median observation time of 42.3 months (range 23.2-73) after first genetic study, 11 out of the 64 (17%) patients showed clonal evolution with the following newly acquired aberrations: del(17p13) (n=4), del(6q21) (n=3), del(11q23) (n=2), +(8q24) (n=1), and evolution from monoallelic to biallelic del(13q14) (n=3).
  • The group with clonal evolution showed a higher rate of progression in Binet stage (82% vs. 28%), a possibly greater need for treatment (91% vs. 62% previously untreated patients received their first therapy), and a higher hazard risk of death (HR = 2.97, 95% CI 1.40-6.27, p=0.004) in multivariable analysis.
  • The estimated median survival time after the occurrence of clonal evolution was 21.7 months.
  • Expansion of the clone with del(17p13) was observed in all patients during treatment, indicating in vivo resistance to therapy.
  • Clonal evolution only occurred in CLL with unmutated VH indicating to karyotypic instability as a pathomechanism.
  • In vivo resistance to chemotherapy of CLL clones with del(17p13) emphasizes the need for alternative treatment approaches in these patients.
  • [MeSH-major] Chromosome Aberrations. Drug Resistance, Neoplasm / genetics. Immunoglobulin Heavy Chains / genetics. Leukemia, Lymphocytic, Chronic, B-Cell / genetics. Leukemia, Lymphocytic, Chronic, B-Cell / pathology. Mutation
  • [MeSH-minor] Cytogenetic Analysis. Disease Progression. Disease-Free Survival. Genome, Human. Humans. In Situ Hybridization, Fluorescence. Neoplasm Staging. Survival Rate. Treatment Outcome

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  • (PMID = 17666364.001).
  • [ISSN] 1592-8721
  • [Journal-full-title] Haematologica
  • [ISO-abbreviation] Haematologica
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] Italy
  • [Chemical-registry-number] 0 / Immunoglobulin Heavy Chains
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3. Zenz T, Kröber A, Scherer K, Häbe S, Bühler A, Benner A, Denzel T, Winkler D, Edelmann J, Schwänen C, Döhner H, Stilgenbauer S: Monoallelic TP53 inactivation is associated with poor prognosis in chronic lymphocytic leukemia: results from a detailed genetic characterization with long-term follow-up. Blood; 2008 Oct 15;112(8):3322-9
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  • [Title] Monoallelic TP53 inactivation is associated with poor prognosis in chronic lymphocytic leukemia: results from a detailed genetic characterization with long-term follow-up.
  • The exact prognostic role of TP53 mutations (without 17p deletion) and any impact of the deletion without TP53 mutation in CLL are unclear.
  • We studied 126 well-characterized CLL patients by direct sequencing and DHPLC to detect TP53 mutations (exons 2-11).
  • We found a shorter survival for patients with TP53 mutation (n = 18; P = .002), which was more pronounced when analyzed from the time point of mutation detection (6.8 vs 69 months, P < .001).
  • The prognostic impact of TP53 mutation (HR 3.71) was shown to be independent of stage, VH status, and 11q and 17p deletion in multivariate analysis.
  • Serial samples showed evidence of clonal evolution and increasing clone size during chemotherapy, suggesting that there may be patients where this treatment is potentially harmful.
  • TP53 mutations are associated with poor sur-vival once they occur in CLL.
  • The de-monstration of clonal evolution under selective pressure supports the biologic significance of TP53 mutations in CLL.
  • [MeSH-major] Genes, p53. Leukemia, Lymphocytic, Chronic, B-Cell / diagnosis. Leukemia, Lymphocytic, Chronic, B-Cell / genetics. Mutation
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Chromosomes, Human, Pair 17. Cohort Studies. Follow-Up Studies. Gene Deletion. Humans. Middle Aged. Prognosis. Time Factors. Treatment Outcome

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  • (PMID = 18689542.001).
  • [ISSN] 1528-0020
  • [Journal-full-title] Blood
  • [ISO-abbreviation] Blood
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
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4. 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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5. Patriarca F, Gaidano G, Capello D, Zaja F, Fanin R, Baccarani M: Occurrence of multiple myeloma after fludarabine treatment of a chronic lymphocytic leukemia: evidence of a biclonal derivation and clinical response to autologous stem cell transplantation. Haematologica; 2000 Sep;85(9):982-5
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Occurrence of multiple myeloma after fludarabine treatment of a chronic lymphocytic leukemia: evidence of a biclonal derivation and clinical response to autologous stem cell transplantation.
  • BACKGROUND AND OBJECTIVES: The occurrence of chronic lymphocyte leukemia (CLL) and multiple myeloma (MM) in a single individual is rare and there is no consensus about the clonal relationship of the two disorders and no clinical data about the response to therapy.
  • DESIGN AND METHODS: We describe a 49-year old patient who developed a III stage IgD k MM after fludarabine treatment for a previous diagnosis of CLL and then was submitted to an high-dose treatment with autologous CD34+ selected stem cell support.
  • An immunologic and molecular characterisation of peripheral blood and bone marrow was performed at the time of appearance of the two coexisting neoplasms.
  • RESULTS: By immunophenotyping, monoclonal B-lymphocytes stained with l chains, whereas marrow plasma cells were positive for k chains.
  • During an 18 months follow-up after autotransplantation, the CLL-related clone became undetectable, whereas MM persisted with a minimal amount of Bence Jones proteinuria and a 15-20% plasma cell marrow infiltration.
  • INTERPRETATION AND CONCLUSIONS: Our results suggest that in this patient CLL and MM originate from separate B-cell progenitors.
  • [MeSH-minor] Antineoplastic Agents / adverse effects. Antineoplastic Agents / therapeutic use. B-Lymphocytes / immunology. Clone Cells / immunology. Clone Cells / pathology. Gene Rearrangement. Hematopoietic Stem Cell Transplantation. Humans. Immunoglobulin Heavy Chains. Immunophenotyping. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy. Leukemia, Lymphocytic, Chronic, B-Cell / immunology. Male. Middle Aged. Neoplasms, Second Primary / etiology. Neoplasms, Second Primary / immunology. Transplantation, Autologous


6. 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
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  • [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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7. Lenz G, Hiddemann W, Dreyling M: The role of fludarabine in the treatment of follicular and mantle cell lymphoma. Cancer; 2004 Sep 1;101(5):883-93
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  • [Title] The role of fludarabine in the treatment of follicular and mantle cell lymphoma.
  • Advanced-stage follicular lymphoma (FL) and mantle cell lymphoma (MCL) cannot be cured using conventional chemotherapy.
  • Fludarabine, the most widely used purine analog, exhibits a particularly high level of activity against small lymphocytic lymphoma and chronic lymphocytic leukemia (CLL).
  • Numerous studies have investigated the efficacy of fludarabine as a single agent or in combination with other cytostatic compounds in the treatment of FL and MCL.
  • Fludarabine monotherapy has proven to be particularly effective in the treatment of FL; however, complete responses (CRs) are observed in only approximately 20-40% of all cases.
  • In summary, fludarabine has proven to be a safe and effective agent in the treatment of indolent lymphoma.
  • In particular, combinations containing fludarabine, anthracyclines and/or alkylating agents, and rituximab have yielded remarkable CR and PFS rates.
  • Consequently, current research efforts have focused on the use of fludarabine-containing combinations in the first-line treatment of FL and MCL.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Lymphoma, Follicular / drug therapy. Lymphoma, Mantle-Cell / drug therapy. Vidarabine / analogs & derivatives. Vidarabine / therapeutic use

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  • [Copyright] Copyright 2004 American Cancer Society.
  • (PMID = 15329894.001).
  • [ISSN] 0008-543X
  • [Journal-full-title] Cancer
  • [ISO-abbreviation] Cancer
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; EC 2.1.1.37 / DNA (Cytosine-5-)-Methyltransferase; FA2DM6879K / Vidarabine; P2K93U8740 / fludarabine
  • [Number-of-references] 74
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8. 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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9. 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
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  • [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).
  • 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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10. Hiddemann W, Dreyling M: Mantle cell lymphoma: therapeutic strategies are different from CLL. Curr Treat Options Oncol; 2003 Jun;4(3):219-26
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Mantle cell lymphoma: therapeutic strategies are different from CLL.
  • In contrast to the typical course of chronic lymphocytic lymphoma and despite an indolent lymphoma-like presentation, the clinical outcome of mantle cell lymphoma (MCL) is dismal, with a median survival time of 3 years and virtually no long-term survivors.
  • Most patients are diagnosed with advanced stage III/IV disease.
  • Although clinical studies did not prove a clear superiority of anthracyclin-containing combinations, CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone)-like regimens represent the standard therapeutic approach in MCL.
  • Recent randomized studies have shown a benefit of a combined immunochemotherapy strategy (chemotherapy plus rituximab) increasing the complete and overall response rates, whereas further follow-up is pending for evaluation of the progression-free and overall survival.
  • However, despite the benefits of this multimodal approach, most patients relapse even after high-dose therapy.
  • Prospective randomized trials remain critical to further improve the clinical course of MCL with the addition of newer treatment modalities, such as radioactively labeled antibodies and targeted therapies (eg, flavopiridol and PS-341).
  • [MeSH-major] Leukemia, Lymphocytic, Chronic, B-Cell / therapy. Lymphoma, Mantle-Cell / therapy
  • [MeSH-minor] Antineoplastic Agents / therapeutic use. Humans. Immunophenotyping. Immunotherapy. Stem Cell Transplantation / methods

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  • (PMID = 12718799.001).
  • [ISSN] 1527-2729
  • [Journal-full-title] Current treatment options in oncology
  • [ISO-abbreviation] Curr Treat Options Oncol
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article; Review
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents
  • [Number-of-references] 46
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11. Cvetković RS, Perry CM: Spotlight on rituximab in non-Hodgkin lymphoma and chronic lymphocytic leukemia. BioDrugs; 2006;20(4):253-7
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  • [Title] Spotlight on rituximab in non-Hodgkin lymphoma and chronic lymphocytic leukemia.
  • Rituximab (MabThera, Rituxan is an anti-CD20 monoclonal antibody that induces lysis and apoptosis of normal and malignant human B cells, and sensitizes malignant B cells to the cytotoxic effect of chemotherapy.
  • In phase III trials in patients with indolent or aggressive B-cell non-Hodgkin lymphoma (NHL), intravenous rituximab in combination with chemotherapy was more effective as first- or second-line therapy than chemotherapy alone in terms of tumor remission and patient survival.
  • Likewise, in patients with chronic lymphocytic leukemia (CLL), rituximab in combination with chemotherapy appeared more effective than chemotherapy alone as either first- or second-line treatment.
  • In addition, rituximab maintenance therapy was shown to significantly prolong tumor remission and patient survival in patients with indolent B-cell NHL or CLL.
  • The combination of rituximab with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) was cost effective as first-line therapy for advanced-stage diffuse large B-cell NHL compared with CHOP alone.
  • Rituximab, either alone or in combination with chemotherapy, was generally well tolerated in patients with NHL or CLL.
  • Overall, rituximab in combination with chemotherapy, is a valuable option for first- and second-line therapy in patients with advanced-stage indolent or aggressive B-cell NHL, and possibly those with B-cell CLL, and is included in current treatment guidelines for these indications.
  • The drug is also potentially useful as maintenance therapy in patients with indolent B-cell NHL or CLL.
  • [MeSH-major] Antibodies, Monoclonal / therapeutic use. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy. Lymphoma, Non-Hodgkin / drug therapy
  • [MeSH-minor] Antibodies, Monoclonal, Murine-Derived. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Humans. Rituximab. Treatment Outcome

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  • (PMID = 16831024.001).
  • [ISSN] 1173-8804
  • [Journal-full-title] BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy
  • [ISO-abbreviation] BioDrugs
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] New Zealand
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antibodies, Monoclonal, Murine-Derived; 4F4X42SYQ6 / Rituximab
  • [Number-of-references] 45
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12. Cvetković RS, Perry CM: Rituximab: a review of its use in non-Hodgkin's lymphoma and chronic lymphocytic leukaemia. Drugs; 2006;66(6):791-820
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Rituximab: a review of its use in non-Hodgkin's lymphoma and chronic lymphocytic leukaemia.
  • Rituximab (MabThera, Rituxan) is an anti-CD20 monoclonal antibody that induces lysis and apoptosis of normal and malignant human B cells, and sensitises malignant B cells to the cytotoxic effect of chemotherapy.
  • In phase III trials in patients with indolent or aggressive B-cell non-Hodgkin's lymphoma (NHL), intravenous rituximab in combination with chemotherapy was more effective as first- or second-line therapy than chemotherapy alone in providing tumour remission and patient survival.
  • Likewise, in patients with chronic lymphocytic leukaemia (CLL), rituximab in combination with chemotherapy appeared more effective than chemotherapy alone as either first- or second-line treatment.
  • In addition, rituximab maintenance therapy was shown to significantly prolong tumour remission and patient survival in patients with indolent B-cell NHL or CLL.
  • The combination of rituximab with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) was cost effective as first-line therapy for advanced-stage diffuse large B-cell NHL compared with CHOP alone.
  • Rituximab, either alone or in combination with chemotherapy, was generally well tolerated in patients with NHL or CLL.
  • Overall, rituximab in combination with chemotherapy, is a valuable option for first- and second-line therapy in patients with advanced-stage indolent or aggressive B-cell NHL, and possibly those with B-cell CLL, and is included in current treatment guidelines for these indications.
  • The drug is also potentially useful as maintenance therapy in patients with indolent B-cell NHL or CLL.
  • [MeSH-major] Antibodies, Monoclonal / therapeutic use. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy. Lymphoma, Non-Hodgkin / drug therapy
  • [MeSH-minor] Antibodies, Monoclonal, Murine-Derived. Antineoplastic Agents / economics. Antineoplastic Agents / therapeutic use. Clinical Trials as Topic. Drug Therapy, Combination. Humans. Meta-Analysis as Topic. Rituximab. Treatment Outcome

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  • (PMID = 16706552.001).
  • [ISSN] 0012-6667
  • [Journal-full-title] Drugs
  • [ISO-abbreviation] Drugs
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] New Zealand
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antibodies, Monoclonal, Murine-Derived; 0 / Antineoplastic Agents; 4F4X42SYQ6 / Rituximab
  • [Number-of-references] 108
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13. Valgañón M, Giraldo P, Agirre X, Larráyoz MJ, Rubio-Martinez A, Rubio-Felix D, Calasanz MJ, Odero MD: p53 Aberrations do not predict individual response to fludarabine in patients with B-cell chronic lymphocytic leukaemia in advanced stages Rai III/IV. Br J Haematol; 2005 Apr;129(1):53-9
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  • [Title] p53 Aberrations do not predict individual response to fludarabine in patients with B-cell chronic lymphocytic leukaemia in advanced stages Rai III/IV.
  • Abnormalities of p53 have been associated with short survival and non-response to therapy in chronic lymphocytic leukaemia (CLL).
  • We have evaluated the rate of response to fludarabine as first-line therapy in 54 patients with advanced stage CLL, analysing the cytogenetic profile, aberrations in p53, including the methylation status of its promoter, and the immunoglobulin heavy-chain variable-region (IGVH) mutation status.
  • According to the advanced stage of the disease in this series, 75% of patients presented genetic aberrations associated with poor prognosis: del(17p) and/or del(11q), and no-mutated IGVH genes.
  • Although we found a significant correlation between failures and the presence of p53 aberrations (P = 0.0065), either with methylation (P = 0.018) or deletion (P = 0.015), 64% of the patients with aberrations in this gene responded to treatment (11/17), suggesting that fludarabine induces high remission rates, even in these patients.
  • This is the first time that the significance of p53 promoter methylation status is described in this pathology, and our data support that this epigenetic phenomenon could be involved in the pathogenesis and clinical evolution of CLL.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Genes, p53. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy. Leukemia, Lymphocytic, Chronic, B-Cell / genetics. Vidarabine / analogs & derivatives
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Chromosome Aberrations. DNA Methylation. DNA Mutational Analysis. DNA, Neoplasm / genetics. Female. Humans. Immunoglobulin Heavy Chains / genetics. Immunoglobulin Variable Region / genetics. In Situ Hybridization, Fluorescence / methods. Male. Middle Aged. Neoplasm Staging. Prognosis. Promoter Regions, Genetic / genetics. Treatment Outcome

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  • (PMID = 15801955.001).
  • [ISSN] 0007-1048
  • [Journal-full-title] British journal of haematology
  • [ISO-abbreviation] Br. J. Haematol.
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / DNA, Neoplasm; 0 / Immunoglobulin Heavy Chains; 0 / Immunoglobulin Variable Region; FA2DM6879K / Vidarabine; P2K93U8740 / fludarabine
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14. 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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15. Robak T, Dmoszynska A, Solal-Céligny P, Warzocha K, Loscertales J, Catalano J, Afanasiev BV, Larratt L, Geisler CH, Montillo M, Zyuzgin I, Ganly PS, Dartigeas C, Rosta A, Maurer J, Mendila M, Saville MW, Valente N, Wenger MK, Moiseev SI: Rituximab plus fludarabine and cyclophosphamide prolongs progression-free survival compared with fludarabine and cyclophosphamide alone in previously treated chronic lymphocytic leukemia. J Clin Oncol; 2010 Apr 1;28(10):1756-65
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  • [Title] Rituximab plus fludarabine and cyclophosphamide prolongs progression-free survival compared with fludarabine and cyclophosphamide alone in previously treated chronic lymphocytic leukemia.
  • PURPOSE: Rituximab, a monoclonal antibody that targets the CD20 cell surface antigen, has clinical activity in patients with non-Hodgkin's lymphoma and other B-lymphocyte disorders when administered alone or in combination with chemotherapy.
  • Promising results have previously been reported in nonrandomized studies in patients with chronic lymphocytic leukemia (CLL).
  • This trial was designed to compare chemoimmunotherapy with chemotherapy alone in patients with previously treated CLL.
  • PATIENTS AND METHODS: This international, multicenter, randomized trial compared six cycles of rituximab plus fludarabine and cyclophosphamide (R-FC) with six cycles of fludarabine and cyclophosphamide alone (FC) in patients with previously treated CLL.
  • A total of 552 patients with Binet stage A (1%), B (59%), or C (31%) disease entered the study and were randomly assigned to receive R-FC (n = 276) or FC (n = 276).
  • RESULTS: After a median follow-up time of 25 months, rituximab significantly improved progression-free survival in patients with previously treated CLL (hazard ratio = 0.65; P < .001; median, 30.6 months for R-FC v 20.6 months for FC).
  • Event-free survival, response rate, complete response rate, duration of response, and time to new CLL treatment or death were also significantly improved.
  • CONCLUSION: R-FC significantly improved the outcome of patients with previously treated CLL.
  • [MeSH-major] Antibodies, Monoclonal / administration & dosage. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Cyclophosphamide / administration & dosage. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy. Vidarabine / analogs & derivatives

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  • (PMID = 20194844.001).
  • [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 III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antibodies, Monoclonal, Murine-Derived; 4F4X42SYQ6 / Rituximab; 8N3DW7272P / Cyclophosphamide; FA2DM6879K / Vidarabine; P2K93U8740 / fludarabine
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16. Knauf WU, Lissichkov T, Aldaoud A, Liberati A, Loscertales J, Herbrecht R, Juliusson G, Postner G, Gercheva L, Goranov S, Becker M, Fricke HJ, Huguet F, Del Giudice I, Klein P, Tremmel L, Merkle K, Montillo M: Phase III randomized study of bendamustine compared with chlorambucil in previously untreated patients with chronic lymphocytic leukemia. J Clin Oncol; 2009 Sep 10;27(26):4378-84
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  • [Title] Phase III randomized study of bendamustine compared with chlorambucil in previously untreated patients with chronic lymphocytic leukemia.
  • PURPOSE: This randomized, open-label, parallel-group, multicenter study was designed to compare the efficacy and safety of bendamustine and chlorambucil in previously untreated patients with advanced (Binet stage B or C) chronic lymphocytic leukemia (CLL).
  • PATIENTS AND METHODS: Patients (<or= 75 years of age) were randomly assigned to receive bendamustine 100 mg/m(2)/d intravenously on days 1 to 2, or chlorambucil 0.8 mg/kg (Broca's normal weight) orally on days 1 and 15; treatment cycles were repeated every 4 weeks for a maximum of six cycles.
  • The response to treatment was assessed according to National Cancer Institute Working Group criteria, and the final determination of response was made by a blinded independent review committee.
  • CONCLUSION: Bendamustine offers significantly greater efficacy than chlorambucil, and a manageable toxicity profile, when used as first-line therapy in patients with advanced CLL.
  • [MeSH-major] Chlorambucil / therapeutic use. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy. Nitrogen Mustard Compounds / therapeutic use
  • [MeSH-minor] Adult. Aged. Antineoplastic Agents / adverse effects. Antineoplastic Agents / therapeutic use. Bendamustine Hydrochloride. Disease-Free Survival. Female. Fever / chemically induced. Follow-Up Studies. Humans. Male. Middle Aged. Nausea / chemically induced. Neutropenia / chemically induced. Thrombocytopenia / chemically induced. Time Factors. Treatment Outcome

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  • (PMID = 19652068.001).
  • [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 III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Nitrogen Mustard Compounds; 18D0SL7309 / Chlorambucil; 981Y8SX18M / Bendamustine Hydrochloride
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17. Rao RA, Chin K, Pilichowska M, Foss F: Outcomes in peripheral T-cell lymphoma: Prognosis based on IPI staging. J Clin Oncol; 2004 Jul 15;22(14_suppl):6706

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  • : 6706 Background: The T cell non-Hodgkin's lymphomas comprise a heterogeneous group of diseases which, with the exception of anaplastic large cell lymphoma, are associated with short response durations and survival after conventional cytotoxic chemotherapy .
  • The histopathologic subtypes included: AILD (5), NK-T cell lymphoma (2), PTCLu (14), HTLV-1 associated ATL (3), T-CLL (6), T-ALL (5).
  • The majority of patients had advanced disease (31 stage IV, 3 Stage III) at presentation.
  • The majority of patients (68%) were treated with anthracycline based multi-agent chemotherapy.

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  • (PMID = 28014609.001).
  • [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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18. Mukiibi JM, Paul B, Nyirenda CM, Adewuyi JO, Gwanzura C, Mzulu E, Mbvundula EM, Magombo ED, Malata HN: Chronic lymphocytic leukaemia (CLL) in Central Africans. Cent Afr J Med; 2004 Nov-Dec;50(11-12):111-5

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  • [Title] Chronic lymphocytic leukaemia (CLL) in Central Africans.
  • OBJECTIVE: To document the clinical and haematological features of chronic lymphocytic leukaemia (CLL) in Central Africans.
  • The majority of patients (78.7%) had Rai stage III and IV and only seven (9.3%) patients were in stage 0.
  • Of the 32 patients treated with chemotherapy, 25.9% and 59.3% achieved complete or partial remissions respectively.
  • In the untreated group of 43 patients, two refused therapy, four died shortly after diagnosis and 37 were lost to follow up.
  • CONCLUSIONS AND RECOMMENDATIONS: Although the study has disclosed that CLL is not rare in central Africans and its presentations are similar to cases reported in the literature, the majority of patients seek medical treatment late.
  • Optimal therapy is impossible due to lack of chemotherapy and supportive services..Therefore, it is recommended that tertiary referral centers in African health systems should be equipped for better management of CLL patients.
  • [MeSH-major] Leukemia, Lymphocytic, Chronic, B-Cell / epidemiology

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  • (PMID = 16615660.001).
  • [ISSN] 0008-9176
  • [Journal-full-title] The Central African journal of medicine
  • [ISO-abbreviation] Cent Afr J Med
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] Zimbabwe
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19. 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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20. 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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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. Zenz T, Mertens D, Döhner H, Stilgenbauer S: Molecular diagnostics in chronic lymphocytic leukemia - pathogenetic and clinical implications. Leuk Lymphoma; 2008 May;49(5):864-73
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  • [Title] Molecular diagnostics in chronic lymphocytic leukemia - pathogenetic and clinical implications.
  • The clinical staging systems by Rai and Binet have remained the mainstay for clinical decision-making in patients with chronic lymphocytic leukemia (CLL).
  • However, there is substantial heterogeneity of the disease within the clinical stage groups.
  • In recent years, molecular and cellular markers have helped to predict the prognosis of CLL patients.
  • The mutation status of the variable region of the Ig heavy chain (VH status) and genomic aberrations subdivide CLL into distinct clinical subgroups.
  • Fluorescence in situ hybridization (FISH) can identify genomic aberrations in approximately 80% of CLL cases.
  • Apart from providing insights into the pathogenesis, genomic aberrations identify subgroups of patients with distinct clinical pictures (lymphadenopathy (11q-) or chemotherapy resistance (17p-)).
  • Deletions at 11q and particularly 17p are associated with rapid disease progression or inferior survival and patients with these genetic abnormalities are candidates for clinical trials investigating alternative treatments and stem cell transplantation.
  • Similarly, abnormalities associated with good prognosis may benefit from de-escalation of current treatment approaches.
  • [MeSH-major] Leukemia, Lymphocytic, Chronic, B-Cell / diagnosis. Molecular Diagnostic Techniques / methods

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  • (PMID = 18452094.001).
  • [ISSN] 1029-2403
  • [Journal-full-title] Leukemia & lymphoma
  • [ISO-abbreviation] Leuk. Lymphoma
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] England
  • [Number-of-references] 60
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23. 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
  • [MeSH-minor] Acute Disease. Adult. Aged. Bone Marrow / pathology. Chlorambucil / administration & dosage. Chlorambucil / adverse effects. Chromosome Aberrations. Clinical Trials, Phase III as Topic. Female. Follow-Up Studies. Humans. Male. Middle Aged. Remission Induction. Retrospective Studies. Vidarabine / administration & dosage. Vidarabine / adverse effects. Vidarabine / analogs & derivatives

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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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24. 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.
  • 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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25. Keating MJ, O'Brien S, Albitar M, Lerner S, Plunkett W, Giles F, Andreeff M, Cortes J, Faderl S, Thomas D, Koller C, Wierda W, Detry MA, Lynn A, Kantarjian H: Early results of a chemoimmunotherapy regimen of fludarabine, cyclophosphamide, and rituximab as initial therapy for chronic lymphocytic leukemia. J Clin Oncol; 2005 Jun 20;23(18):4079-88
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  • [Title] Early results of a chemoimmunotherapy regimen of fludarabine, cyclophosphamide, and rituximab as initial therapy for chronic lymphocytic leukemia.
  • PURPOSE: Fludarabine and cyclophosphamide (FC), which are active in treatment of chronic lymphocytic leukemia (CLL), are synergistic with the monoclonal antibody rituximab in vitro in lymphoma cell lines.
  • A chemoimmunotherapy program consisting of fludarabine, cyclophosphamide, and rituximab (FCR) was developed with the goal of increasing the complete remission (CR) rate in previously untreated CLL patients to >/= 50%.
  • PATIENTS AND METHODS: We conducted a single-arm study of FCR as initial therapy in 224 patients with progressive or advanced CLL.
  • RESULTS: The median age was 58 years; 75 patients (33%) had Rai stage III to IV disease.
  • The CR rate was 70% (95% CI, 63% to 76%), the nodular partial remission rate was 10%, and the partial remission rate was 15%, for an overall response rate of 95% (95% CI, 92% to 98%).
  • Two thirds of patients evaluated with flow cytometry had less than 1% CD5- and CD19-coexpressing cells in bone marrow after therapy.
  • CONCLUSION: FCR produced a high CR rate in previously untreated CLL.
  • Most patients had no detectable disease on flow cytometry at the end of therapy.
  • Time to treatment failure analysis showed that 69% of patients were projected to be failure free at 4 years (95% CI, 57% to 81%).
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy. Vidarabine / analogs & derivatives
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Antibodies, Monoclonal / administration & dosage. Antibodies, Monoclonal, Murine-Derived. Cyclophosphamide / administration & dosage. Female. Flow Cytometry. Humans. Male. Middle Aged. Remission Induction. Rituximab. Survival Analysis. Treatment Outcome

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  • [CommentIn] Curr Hematol Malig Rep. 2006 Mar;1(1):41-2 [20425330.001]
  • [CommentIn] J Clin Oncol. 2005 Jun 20;23(18):4009-12 [15767640.001]
  • (PMID = 15767648.001).
  • [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; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antibodies, Monoclonal, Murine-Derived; 4F4X42SYQ6 / Rituximab; 8N3DW7272P / Cyclophosphamide; FA2DM6879K / Vidarabine; P2K93U8740 / fludarabine
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26. 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
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  • [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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27. 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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  • 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

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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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28. Martell RE, Peterson BL, Cohen HJ, Petros WP, Rai KR, Morrison VA, Elias L, Shepherd L, Hines J, Larson RA, Schiffer CA, Hurwitz HI: Analysis of age, estimated creatinine clearance and pretreatment hematologic parameters as predictors of fludarabine toxicity in patients treated for chronic lymphocytic leukemia: a CALGB (9011) coordinated intergroup study. Cancer Chemother Pharmacol; 2002 Jul;50(1):37-45
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Analysis of age, estimated creatinine clearance and pretreatment hematologic parameters as predictors of fludarabine toxicity in patients treated for chronic lymphocytic leukemia: a CALGB (9011) coordinated intergroup study.
  • PURPOSE: Fludarabine is a renally excreted agent that is an effective treatment for chronic lymphocytic leukemia (CLL), a disease predominantly of the elderly.
  • We sought to determine whether age, renal function or pretreatment hematologic status predicted toxicity of fludarabine treatment for CLL.
  • METHODS: We evaluated 192 patients with previously untreated B-cell CLL who were entered onto the fludarabine treatment arm (25 mg/m(2) daily for 5 days every 28 days) of CALGB study 9011, an intergroup study with participation from SWOG, CTG/NCI-C and ECOG.
  • Patients were required to have serum creatinine within 1.5 times normal.
  • Hematologic indices and infections were recorded during the first 28-day cycle of treatment.
  • A time-to-toxicity endpoint was evaluated over the entire course of fludarabine treatment.
  • Creatinine clearance (CrCl(est)) was estimated using serum creatinine, age and body mass index.
  • RESULTS: The median age was 64 years (range 37-87 years) and median CrCl(est) was 62 ml/min (range 27-162 ml/min, interquartile range 52-79 ml/min).
  • We found no association between age and incidence of hematologic toxicity or infection during the first cycle of treatment.
  • There was a strong association between CrCl(est) and the time-to-toxicity endpoint.
  • Patients with CrCl(est) below 80 ml/min had increased incidence of toxicity during their treatment course ( P<0.0001).
  • Pretreatment anemia, thrombocytopenia and Rai stage were highly associated with the incidence of neutrophil toxicity and grade III/IV hematologic toxicities during the first cycle of treatment ( P<0.0001).
  • CONCLUSIONS: Patient age was not an independent risk factor for fludarabine-related toxicity, but CrCl(est) was associated with time to toxicity.
  • [MeSH-major] Antineoplastic Agents / adverse effects. Creatinine / blood. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy. Vidarabine / adverse effects
  • [MeSH-minor] Adult. Age Factors. Aged. Aged, 80 and over. Body Mass Index. Disease-Free Survival. Female. Hematologic Tests. Humans. Kidney Function Tests. Leukocyte Count. Male. Middle Aged. Neoplasm Staging. Neutrophils / drug effects

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  • (PMID = 12111110.001).
  • [ISSN] 0344-5704
  • [Journal-full-title] Cancer chemotherapy and pharmacology
  • [ISO-abbreviation] Cancer Chemother. Pharmacol.
  • [Language] eng
  • [Grant] United States / NIA NIH HHS / AG / T32AG00029
  • [Publication-type] Clinical Trial; Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] Germany
  • [Chemical-registry-number] 0 / Antineoplastic Agents; AYI8EX34EU / Creatinine; FA2DM6879K / Vidarabine; P2K93U8740 / fludarabine
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29. Dennie TW, Kolesar JM: Bendamustine for the treatment of chronic lymphocytic leukemia and rituximab-refractory, indolent B-cell non-Hodgkin lymphoma. Clin Ther; 2009;31 Pt 2:2290-311
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  • [Title] Bendamustine for the treatment of chronic lymphocytic leukemia and rituximab-refractory, indolent B-cell non-Hodgkin lymphoma.
  • Bendamustine was approved by the US Food and Drug Administration (FDA) for the treatment of chronic lymphocytic leukemia (CLL) in March 2008 and for the treatment of rituximab-refractory, indolent B-cell non-Hodgkin lymphoma (NHL) in October 2008.
  • OBJECTIVE: This article reviews the pharmacologic and pharmacodynamic properties of bendamustine, together with data on efficacy and toxicity from trials investigating the use of bendamustine for the treatment of various hematologic malignancies, including CLL, NHL, and multiple myeloma (MM).
  • RESULTS: Bendamustine is a mechlorethamine derivative with structural similarity to chlorambucil and other drugs from the nitrogen mustard class, as well as a benzimidazole ring, which may act as an antagonist to purines and amino acids.
  • While bendamustine has 2 moieties with possible antitumor effect, it is unclear to what extent the benzimidazole ring enhances the efficacy of the drug.
  • FDA approval for use in CLL was based on findings from a randomized, open-label, Phase III study comparing bendamustine with chlorambucil as single-agent therapy in treatmentnaive patients with CLL (Binet stage B or C).
  • FDA approval for rituximabrefractory, indolent B-cell NHL followed a Phase III, open-label, single-arm study evaluating bendamustine monotherapy in patients who did not respond to rituximab or had progressive disease within 6 months of rituximab therapy.
  • The efficacy of bendamustine has also been reported in the treatment of MM in clinical studies, and bendamustine has been approved in Europe for treating MM, NHL, CLL, breast cancer, and Hodgkin lymphoma.
  • Treatment-associated infections have been reported in some studies; however, nonhematologic adverse events have rarely been dose limiting.
  • It has been approved in the United States for the treatment of CLL and rituximab-refractory, indolent B-cell NHL.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy. Lymphoma, B-Cell / drug therapy. Nitrogen Mustard Compounds / therapeutic use
  • [MeSH-minor] Antibodies, Monoclonal / therapeutic use. Antibodies, Monoclonal, Murine-Derived. Bendamustine Hydrochloride. Drug Administration Schedule. Drug Resistance, Neoplasm / drug effects. Humans. Rituximab


30. 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


31. 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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32. 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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33. Hong M, Xu W, Qian SX, Miao KR, Fan L, Li JY: [High-dose methylprednisolone for the treatment of refractory chronic lymphocytic leukemia]. Zhongguo Shi Yan Xue Ye Xue Za Zhi; 2009 Aug;17(4):1052-5
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  • [Title] [High-dose methylprednisolone for the treatment of refractory chronic lymphocytic leukemia].
  • To investigate the curative effects of high-dose methylprednisolone (HDMP) in the treatment of refractory chronic lymphocytic leukemia (CLL), 5 patients with CLL who poorly reacted to several cycles of fludarabine based protocols with or without rituximab were treated with 1 to 6 cycles of HDMP with 1 g/(m(2)xd) for d1-5.
  • All the patients were at Binet stage C. 3 patients were at Rai stage IV and 2 were at Rai stage III.
  • All the patients developed with B group symptoms including fever, night sweat and/or weight loss and so on.
  • The results showed that B group symptoms disappeared in 4 patients at 2 - 4 weeks after therapy.
  • In 1 patient spleen was not palpable from 10 cm below costal margin at 2 weeks after therapy, and his hemafecia was alleviated.
  • The renal function in another patient with renal failure recovered to normal after two cycles of therapy.
  • Pancytopenia improved in 3 patients after therapy.
  • In conclusion, the therapeutic results preliminarily show that HDMP is an effective and safe protocol for the treatment of refractory CLL.

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  • (PMID = 19698258.001).
  • [ISSN] 1009-2137
  • [Journal-full-title] Zhongguo shi yan xue ye xue za zhi
  • [ISO-abbreviation] Zhongguo Shi Yan Xue Ye Xue Za Zhi
  • [Language] CHI
  • [Publication-type] Clinical Trial; English Abstract; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] China
  • [Chemical-registry-number] X4W7ZR7023 / Methylprednisolone
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34. Seipelt G, Böhme A, Koschmieder S, Hoelzer D: Effective treatment with rituximab in a patient with refractory prolymphocytoid transformed B-chronic lymphocytic leukemia and Evans syndrome. Ann Hematol; 2001 Mar;80(3):170-3
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  • [Title] Effective treatment with rituximab in a patient with refractory prolymphocytoid transformed B-chronic lymphocytic leukemia and Evans syndrome.
  • A 65-year-old male who had been diagnosed as having chronic lymphocytic leukemia (CLL) stage Rai 0 three years previously presented in October 1998 with progressive disease (splenomegaly, increasing lymphocytosis: 30/nl) and 50% prolymphocytes in his peripheral blood.
  • The patient was refractory to initial treatment with fludarabine and epirubicin, and 2-chlorodeoxyadenosine.
  • Additionally, the patient developed Evans syndrome.
  • Therapy with cyclophosphamide, vincristine, and prednisone lead to an improvement of hemolysis, but the patient remained thrombocytopenic.
  • At this stage, therapy with rituximab 375 mg/m2 four times weekly was initiated.
  • This case demonstrates that patients with prolymphocytoid transformed B-CLL refractory to purine analogs and alkylating agents and autoimmune-hemolytic disease can effectively and safely be treated with rituximab and indicates that an investigation of antibody therapy is warranted in this patient group.
  • [MeSH-major] Antibodies, Monoclonal / therapeutic use. Antineoplastic Agents / therapeutic use. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy
  • [MeSH-minor] Aged. Anemia, Hemolytic, Autoimmune / complications. Antibodies, Monoclonal, Murine-Derived. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Bendamustine Hydrochloride. Bone Marrow / pathology. Humans. Immunophenotyping. Male. Nitrogen Mustard Compounds / therapeutic use. Remission Induction. Rituximab. Treatment Failure

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  • (PMID = 11320903.001).
  • [ISSN] 0939-5555
  • [Journal-full-title] Annals of hematology
  • [ISO-abbreviation] Ann. Hematol.
  • [Language] eng
  • [Publication-type] Case Reports; Journal Article
  • [Publication-country] Germany
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antibodies, Monoclonal, Murine-Derived; 0 / Antineoplastic Agents; 0 / Nitrogen Mustard Compounds; 4F4X42SYQ6 / Rituximab; 981Y8SX18M / Bendamustine Hydrochloride
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35. Morrison VA, Rai KR, Peterson BL, Kolitz JE, Elias L, Appelbaum FR, Hines JD, Shepherd L, Martell RE, Larson RA, Schiffer CA: Impact of therapy With chlorambucil, fludarabine, or fludarabine plus chlorambucil on infections in patients with chronic lymphocytic leukemia: Intergroup Study Cancer and Leukemia Group B 9011. J Clin Oncol; 2001 Aug 15;19(16):3611-21
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  • [Title] Impact of therapy With chlorambucil, fludarabine, or fludarabine plus chlorambucil on infections in patients with chronic lymphocytic leukemia: Intergroup Study Cancer and Leukemia Group B 9011.
  • PURPOSE: We sought to determine whether therapy with single-agent fludarabine compared with chlorambucil alone or the combination of both agents had an impact on the incidence and spectrum of infections among a series of previously untreated patients with B-cell chronic lymphocytic leukemia (CLL).
  • PATIENTS AND METHODS: Five hundred fifty-four previously untreated CLL patients with intermediate/high-risk Rai-stage disease were enrolled onto an intergroup protocol.
  • Patients were randomized to therapy with chlorambucil, fludarabine, or fludarabine plus chlorambucil.
  • Differences in infections among treatment arms were tested with the Kruskal-Wallis, Wilcoxon, and chi(2) tests.
  • RESULTS: A total of 1,107 infections (241 major infections) occurred in 518 patients over the infection follow-up period (interval from study entry until either reinstitution of initial therapy, therapy with a second agent, or death).
  • Fludarabine therapy was associated with more major infections and more herpesvirus infections compared with chlorambucil (P =.008 and P =.004, respectively).
  • Rai stage and best response to therapy were not associated with infection.
  • CONCLUSION: Combination therapy with fludarabine plus chlorambucil resulted in significantly more infections than treatment with either single agent.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy. Respiratory Tract Infections / mortality. Skin Diseases, Infectious / mortality
  • [MeSH-minor] Administration, Oral. Adult. Aged. Aged, 80 and over. Chlorambucil / administration & dosage. Drug Administration Schedule. Female. Humans. Infusions, Intravenous. Male. Middle Aged. Ontario. Treatment Outcome. United States. Vidarabine / administration & dosage. Vidarabine / analogs & derivatives

  • Genetic Alliance. consumer health - Chronic Lymphocytic Leukemia.
  • MedlinePlus Health Information. consumer health - Skin Infections.
  • COS Scholar Universe. author profiles.
  • Hazardous Substances Data Bank. FLUDARABINE .
  • Hazardous Substances Data Bank. CHLORAMBUCIL .
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  • (PMID = 11504743.001).
  • [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 / CA11028; United States / NCI NIH HHS / CA / CA21115; United States / NCI NIH HHS / CA / CA31946; United States / NCI NIH HHS / CA / CA32102; United States / NCI NIH HHS / CA / CA33601; United States / NCI NIH HHS / CA / CA35279; United States / NCI NIH HHS / CA / CA41287
  • [Publication-type] Clinical Trial; Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; 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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