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1. Ruan J, Martin P, Coleman M, Furman RR, Cheung K, Faye A, Elstrom R, Lachs M, Hajjar KA, Leonard JP: Durable responses with the metronomic rituximab and thalidomide plus prednisone, etoposide, procarbazine, and cyclophosphamide regimen in elderly patients with recurrent mantle cell lymphoma. Cancer; 2010 Jun 1;116(11):2655-64
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Durable responses with the metronomic rituximab and thalidomide plus prednisone, etoposide, procarbazine, and cyclophosphamide regimen in elderly patients with recurrent mantle cell lymphoma.
  • BACKGROUND: Targeting the tumor microenvironment and angiogenesis is a novel lymphoma therapeutic strategy.
  • The authors report safety, activity, and angiogenic profiling results with the rituximab and thalidomide plus prednisone, etoposide, procarbazine, and cyclophosphamide (RT-PEPC) regimen in patients with recurrent mantle cell lymphoma (MCL).
  • METHODS: RT-PEPC included induction (Months 1-3) of rituximab 4 times weekly, daily thalidomide (50 mg), and PEPC followed by maintenance thalidomide (100 mg), oral PEPC titrated to the neutrophil count, and rituximab every 4 months.
  • The median age was 68 years (range, 52-81 years), 24 patients (96%) had stage III or IV disease, 18 patients (72%) had an International Prognostic Index (IPI) score of 3 to 5, and 20 patients (80%) had high-risk Mantle Cell International Prognostic Index (MIPI) scores.
  • Patients had received a median of 2 previous therapies (range, 1-7 previous therapies), and 15 patients (60%) had progressed on bortezomib.
  • Plasma VEGF levels and circulating endothelial cells trended down with treatment.
  • Novel, low-intensity approaches warrant further evaluation, potentially as initial therapy in elderly patients.

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  • [Copyright] (c) 2010 American Cancer Society.
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  • (PMID = 20235190.001).
  • [ISSN] 0008-543X
  • [Journal-full-title] Cancer
  • [ISO-abbreviation] Cancer
  • [Language] ENG
  • [Grant] United States / NHLBI NIH HHS / HL / P01 HL046403; United States / NHLBI NIH HHS / HL / K08 HL091517; United States / NHLBI NIH HHS / HL / R01 HL042493-18; United States / NHLBI NIH HHS / HL / R01 HL090895-03; United States / NHLBI NIH HHS / HL / R01 HL090895; United States / NHLBI NIH HHS / HL / HL042493-18; United States / NHLBI NIH HHS / HL / K08HL091517; United States / NHLBI NIH HHS / HL / R01 HL042493; United States / NHLBI NIH HHS / HL / P01 HL046403-19
  • [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 / Antibodies, Monoclonal; 0 / Antibodies, Monoclonal, Murine-Derived; 35S93Y190K / Procarbazine; 4F4X42SYQ6 / Rituximab; 4Z8R6ORS6L / Thalidomide; 6PLQ3CP4P3 / Etoposide; 8N3DW7272P / Cyclophosphamide; VB0R961HZT / Prednisone
  • [Other-IDs] NLM/ NIHMS257257; NLM/ PMC3004744
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2. Morris GJ, Millenson MM, Padavic-Shaller K, Wang H, Rogatko A, Clyde J, Boyd RL, Yeslow G, Halbherr T, Schilder RJ, Smith MR: Phase II study of fludarabine and alpha-interferon in patients with low-grade non-Hodgkin's lymphoma. Haematologica; 2004 Dec;89(12):1484-91
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  • [Title] Phase II study of fludarabine and alpha-interferon in patients with low-grade non-Hodgkin's lymphoma.
  • BACKGROUND AND OBJECTIVES: Low-grade non-Hodgkin's lymphoma (NHL) remains incurable with standard dose chemotherapy.
  • Nucleoside analogs such as fludarabine are effective, but even when used as initial therapy, the median duration of remission ranges from only 16 to 24 months.
  • Interferon (IFN) is also active and has been investigated both by incorporating it into the chemotherapy regimen and/or as maintenance therapy, where it may prolong remission.
  • We designed a phase II trial of alternating fludarabine and IFNalpha2a to determine response rate, time to progression and toxicity of this regimen in patients with advanced stage low-grade NHL or mantle cell lymphoma.
  • Fludarabine was administered intravenously at 25 mg/m2/day for 5 days once every 6 weeks with IFN in weeks 4 and 5 at 3x10(6) U/m2 subcutaneously three times weekly for 6 doses.
  • Treatment continued in responders for 2 cycles past maximal response (minimum 6 cycles).
  • With a median follow-up of 35.6 months, the median overall survival was 60.8 months, and the median time to disease progression (TTP) was 12.6 months.
  • Of the 15 responding patients, treatment-naive patients had a median response duration of 39.6 months with a median TTP of 42.1 months, while the median response duration was 5.2 months with a median TTP of 14.5 months in patients who had received prior treatment (p=0.0065 and 0.0374, respectively).
  • Given the non-overlapping toxicities of IFN with those of chemotherapy and antibody-based therapeutics, there may be a role for combination therapies, especially if the biological basis of response to IFN can be elucidated.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Lymphoma, Non-Hodgkin / drug therapy
  • [MeSH-minor] Adult. Aged. Disease Progression. Drug Administration Schedule. Fatigue / chemically induced. Female. Follow-Up Studies. Gastrointestinal Diseases / chemically induced. Hematologic Diseases / chemically induced. Humans. Interferon-alpha / administration & dosage. Interferon-alpha / adverse effects. Life Tables. Male. Middle Aged. Proportional Hazards Models. Recombinant Proteins. Survival Analysis. Treatment Outcome. Vidarabine / administration & dosage. Vidarabine / adverse effects. Vidarabine / analogs & derivatives

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  • (PMID = 15590399.001).
  • [ISSN] 1592-8721
  • [Journal-full-title] Haematologica
  • [ISO-abbreviation] Haematologica
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / P30 CA006927.
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] Italy
  • [Chemical-registry-number] 0 / Interferon-alpha; 0 / Recombinant Proteins; 76543-88-9 / interferon alfa-2a; FA2DM6879K / Vidarabine; P2K93U8740 / fludarabine
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3. Ansell SM, Inwards DJ, Rowland KM Jr, Flynn PJ, Morton RF, Moore DF Jr, Kaufmann SH, Ghobrial I, Kurtin PJ, Maurer M, Allmer C, Witzig TE: Low-dose, single-agent temsirolimus for relapsed mantle cell lymphoma: a phase 2 trial in the North Central Cancer Treatment Group. Cancer; 2008 Aug 1;113(3):508-14
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Low-dose, single-agent temsirolimus for relapsed mantle cell lymphoma: a phase 2 trial in the North Central Cancer Treatment Group.
  • BACKGROUND: The objective of this study was to test a low dose of (25 mg weekly) of the mammalian target of rapamycin kinase inhibitor temsirolimus for patients with relapsed mantle cell lymphoma (MCL).
  • Patients who had a tumor response after 6 cycles were eligible to continue drug for a total of 12 cycles or 2 cycles after complete remission and then were observed without maintenance.
  • The median age was 69 years (range, 51-85 years), 86% of patients had stage IV disease, and 71% had > or = 2 extranodal sites.
  • Patients had received a median of 4 prior therapies (range, 1-9 prior therapies), and 50% were refractory to the last treatment.
  • The median time to progression in all eligible patients was 6 months (95% CI, 3-11 months), and the median duration of response for the 11 responders was 6 months (range, 1-26 months).
  • CONCLUSIONS: Single-agent temsirolimus at a dose of 25 mg weekly is an effective new agent for the treatment of MCL.
  • Further studies of temsirolimus in combination with other active drugs for MCL and other lymphoid malignancies are warranted.

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  • [Copyright] (c) 2008 American Cancer Society
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  • (PMID = 18543327.001).
  • [ISSN] 0008-543X
  • [Journal-full-title] Cancer
  • [ISO-abbreviation] Cancer
  • [Language] ENG
  • [Grant] United States / NCI NIH HHS / CA / U10 CA035267; United States / NCI NIH HHS / CA / CA112904; United States / NCI NIH HHS / CA / CA97274; United States / NCI NIH HHS / CA / CA-35090; United States / NCI NIH HHS / CA / U10 CA060276; United States / NCI NIH HHS / CA / CA-35195; United States / NCI NIH HHS / CA / U10 CA037404; United States / NCI NIH HHS / CA / U10 CA035448; United States / NCI NIH HHS / CA / U10 CA063848; United States / NCI NIH HHS / CA / U10 CA035195; United States / NCI NIH HHS / CA / CA-25224; United States / NCI NIH HHS / CA / CA-37403; United States / PHS HHS / / CS-35431; United States / NCI NIH HHS / CA / CA-60276; United States / NCI NIH HHS / CA / CA-35113; United States / NCI NIH HHS / CA / U10 CA035101; United States / NCI NIH HHS / CA / U10 CA035113; United States / NCI NIH HHS / CA / P30 CA015083; United States / NCI NIH HHS / CA / CA-63848; United States / NCI NIH HHS / CA / U10 CA035415; United States / NCI NIH HHS / CA / CA-63826; United States / NCI NIH HHS / CA / R21 CA112904; United States / NCI NIH HHS / CA / CA-35415; United States / NCI NIH HHS / CA / P50 CA097274; United States / NCI NIH HHS / CA / CA-35448; United States / NCI NIH HHS / CA / CA-35101; United States / NCI NIH HHS / CA / U10 CA025224; United States / NCI NIH HHS / CA / U10 CA035090; United States / NCI NIH HHS / CA / CA-15083; United States / NCI NIH HHS / CA / CA-35267; United States / NCI NIH HHS / CA / N01 CA015083
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 624KN6GM2T / temsirolimus; W36ZG6FT64 / Sirolimus
  • [Other-IDs] NLM/ NIHMS454018; NLM/ PMC3627208
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4. Rizzieri DA, Sand GJ, McGaughey D, Moore JO, DeCastro C, Chao NJ, Vredenburgh JJ, Gasparetto C, Long GD, Anderson E, Foster T, Toaso B, Adams D, Niedzwiecki D, Gockerman JP: Low-dose weekly paclitaxel for recurrent or refractory aggressive non-Hodgkin lymphoma. Cancer; 2004 Jun 1;100(11):2408-14
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  • [Title] Low-dose weekly paclitaxel for recurrent or refractory aggressive non-Hodgkin lymphoma.
  • BACKGROUND: Many patients with recurrent, intermediate or high-grade non-Hodgkin lymphoma (NHL) may not respond to or are not candidates for aggressive salvage chemotherapy.
  • Although high-dose taxanes have not been reported to be very effective for the treatment of lymphoma, different delivery rates may allow for different mechanisms of action to be manifest and result in a different toxicity profile and response rate.
  • METHODS: Adults age > 18 years with refractory or recurrent, aggressive NHL who were not considered curable with standard high-dose therapy received paclitaxel at a dose of 80 mg/m2 weekly for 5 weeks for 2 cycles.
  • The median number of prior regimens received was 3, 74% of the patients had an International Prognostic Index of > or = 3 at the time of study entry, and 29% had failed high-dose therapy with autologous hematopoietic support.
  • CONCLUSIONS: In the current study, low-dose, weekly paclitaxel therapy was found to provide a well tolerated and less toxic approach to the treatment of refractory NHL, with encouraging responses noted in heavily pretreated patients.
  • However, evaluation in patients with an earlier stage of disease is warranted.
  • [MeSH-major] Antineoplastic Agents, Phytogenic / administration & dosage. Lymphoma, Non-Hodgkin / drug therapy. Neoplasm Recurrence, Local / drug therapy. Paclitaxel / administration & dosage. Salvage Therapy
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Antineoplastic Combined Chemotherapy Protocols / adverse effects. Carcinoma / drug therapy. Carcinoma / pathology. Female. Humans. Lymphoma, Mantle-Cell / drug therapy. Lymphoma, Mantle-Cell / pathology. Male. Maximum Tolerated Dose. Microcirculation. Middle Aged. Remission Induction

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  • [Copyright] Copyright 2004 American Cancer Society.
  • (PMID = 15160345.001).
  • [ISSN] 0008-543X
  • [Journal-full-title] Cancer
  • [ISO-abbreviation] Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents, Phytogenic; P88XT4IS4D / Paclitaxel
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5. Mangel J, Leitch HA, Connors JM, Buckstein R, Imrie K, Spaner D, Crump M, Pennell N, Boudreau A, Berinstein NL: Intensive chemotherapy and autologous stem-cell transplantation plus rituximab is superior to conventional chemotherapy for newly diagnosed advanced stage mantle-cell lymphoma: a matched pair analysis. Ann Oncol; 2004 Feb;15(2):283-90
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  • [Title] Intensive chemotherapy and autologous stem-cell transplantation plus rituximab is superior to conventional chemotherapy for newly diagnosed advanced stage mantle-cell lymphoma: a matched pair analysis.
  • BACKGROUND: The outcome of 20 patients with newly diagnosed mantle-cell lymphoma (MCL) treated on a prospective trial of autologous stem-cell transplantation (ASCT) and rituximab immunotherapy was compared with the outcome of 40 matched historical control patients treated with standard combination chemotherapy.
  • PATIENTS AND METHODS: Control patients with MCL were identified from a lymphoma database, and pairs were matched with patients receiving ASCT-rituximab for stage of disease, gender and age (+/-5 years).
  • RESULTS: Seventeen of 20 patients who received ASCT-rituximab remain alive in remission at a median of 30 months from diagnosis; one patient relapsed 2 years post-ASCT, and two died at 7 and 11 months post-ASCT without evidence of lymphoma.
  • Of 40 patients treated with conventional chemotherapy, with a median follow-up of 80 months, 33 have relapsed or progressed and 29 have died.
  • Overall (OS) and progression-free (PFS) survival were superior in patients treated with ASCT-rituximab compared with those treated with conventional chemotherapy (PFS at 3 years, 89% versus 29%, P <0.00001; OS at 3 years, 88% versus 65%, P = 0.052).
  • CONCLUSIONS: This matched-pair analysis suggests that patients with advanced-stage MCL treated with ASCT-rituximab had statistically significantly better PFS and a trend toward better OS than patients treated with conventional chemotherapy.
  • Longer follow-up will determine response duration and the true impact of this treatment strategy on PFS and OS.

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  • (PMID = 14760123.001).
  • [ISSN] 0923-7534
  • [Journal-full-title] Annals of oncology : official journal of the European Society for Medical Oncology
  • [ISO-abbreviation] Ann. Oncol.
  • [Language] ENG
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Comparative Study; Journal Article
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antibodies, Monoclonal, Murine-Derived; 0 / Antineoplastic Agents; 4F4X42SYQ6 / Rituximab
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6. Mangel J, Buckstein R, Imrie K, Spaner D, Crump M, Tompkins K, Reis M, Perez-Ordonez B, Deodhare S, Romans R, Pennell N, Robinson JB, Hewitt K, Richardson P, Lima A, Pavlin P, Berinstein NL: Immunotherapy with rituximab following high-dose therapy and autologous stem-cell transplantation for mantle cell lymphoma. Semin Oncol; 2002 Feb;29(1S2):56-69
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Immunotherapy with rituximab following high-dose therapy and autologous stem-cell transplantation for mantle cell lymphoma.
  • Advanced-stage mantle cell lymphoma (MCL) is a disease for which no curative treatment strategy exists.
  • Results with standard combination chemotherapy, with or without an anthracycline, are disappointing, and new and better therapies are needed.
  • High-dose therapy and autologous stem-cell transplantation (ASCT) have been performed in patients with MCL both up front and at relapse with varying degrees of success.
  • It has also been used safely and effectively as an in vivo purge during ASCT for patients with lymphoma.
  • We are currently investigating an aggressive protocol in patients with newly diagnosed, untreated MCL using a combination of two promising therapeutic modalities, high-dose therapy-ASCT and rituximab.
  • Since 1999, 13 patients with newly diagnosed MCL have been enrolled in this phase II clinical trial.
  • CHOP (cyclophosphamide/prednisone/vincristine/doxorubicin) is used as debulking chemotherapy.
  • Stem cells are mobilized with 5 days of granulocyte colony-stimulating factor 10 μg/kg/d, with a single infusion of rituximab 375 mg/m<sup>2</sup> used as an in vivo purge before stem-cell collection by large-volume leukapheresis.
  • So far, 12 patients (7 men/5 women) with a median age of 55 years (range, 41 to 65 years) have been transplanted.
  • Patients engrafted quickly, with a median of 11.5 days to neutrophil engraftment and 10 days to platelet independence.
  • Eight patients have received all eight maintenance rituximab treatments, and four have received only their first cycle.
  • With a median follow-up of 239 days from transplant (range, 61 to 727 days), all patients remain alive and well with no documented relapses.
  • Samples for molecular monitoring have been drawn from the stem-cell graft, and serially from the peripheral blood and bone marrow of patients at baseline, preapheresis, pretransplant, and post-transplant at 3-month intervals.
  • Although patient numbers are low and follow-up time is short, preliminary results are encouraging.

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  • [Copyright] Copyright © 2002 W.B. Saunders Company. All rights reserved.
  • (PMID = 28140093.001).
  • [ISSN] 1532-8708
  • [Journal-full-title] Seminars in oncology
  • [ISO-abbreviation] Semin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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7. Méhes L, Telek B, Udvardy M, Schlammadinger A, és Rejto L: [Mantle cell lymphoma: case report]. Orv Hetil; 2008 Aug 3;149(31):1471-4
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  • [Title] [Mantle cell lymphoma: case report].
  • [Transliterated title] Köpenysejtes lymphoma: esetismertetés.
  • Mantle cell lymphoma (MCL) is a moderately aggressive disease, which is not curable with chemo-immunotherapy.
  • Most of the patients have advanced stage disease at the time of diagnosis.
  • The tumor cells express pan-B-cell markers and the T-cell marker CD5.
  • The overexpression of cyclin D1 was found as another marker for mantle cell lymphoma.
  • Combined chemotherapy, chemo-immunotherapy, autologous peripheral stem cell (and allogenous) transplantation is the treatment of choice.
  • Our two patients had prolonged survival, in spite of missing the best first line therapy.
  • The survival time after the complex treatment (chemo-immunotherapy, irradiation, surgical intervention, autologous stem cell transplantation) was 80 and 90 months, respectively.
  • In addition to the history of two patients, authors review the current treatment options in mantle cell lymphoma.
  • [MeSH-major] Lymphoma, Mantle-Cell / diagnosis. Lymphoma, Mantle-Cell / therapy
  • [MeSH-minor] Aged. Combined Modality Therapy. Female. Humans. Male. Middle Aged. Treatment Outcome

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  • (PMID = 18632508.001).
  • [ISSN] 0030-6002
  • [Journal-full-title] Orvosi hetilap
  • [ISO-abbreviation] Orv Hetil
  • [Language] hun
  • [Publication-type] Case Reports; English Abstract; Journal Article
  • [Publication-country] Hungary
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8. Chang JE, Voorhees PM, Kolesar JM, Ahuja HG, Sanchez FA, Rodriguez GA, Kim K, Werndli J, Bailey HH, Kahl BS: Phase II study of arsenic trioxide and ascorbic acid for relapsed or refractory lymphoid malignancies: a Wisconsin Oncology Network study. Hematol Oncol; 2009 Mar;27(1):11-6
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  • [Title] Phase II study of arsenic trioxide and ascorbic acid for relapsed or refractory lymphoid malignancies: a Wisconsin Oncology Network study.
  • Cell death from As(2)O(3) may be the result of oxidative stress.
  • This multi-institution phase II study investigated a novel dosing schedule of As(2)O(3) and AA in patients with relapsed or refractory lymphoid malignancies.
  • In a subset of patients, sequential levels of intracellular glutathione and measures of Bcl-2 and Bax gene expression were evaluated in peripheral blood mononuclear cells during treatment.
  • The median age was 71, and the majority of enrolled patients had non-Hodgkin's lymphoma (12/17).
  • Sixteen patients were evaluable, and one patient with mantle cell lymphoma achieved an unconfirmed complete response after five cycles of therapy for an overall response rate of 6%.
  • The trial, which had been designed as a two-stage study, was closed after the first stage analysis due to lack of activity.
  • Intracellular depletion of glutathione was not consistently observed during treatment.

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  • [Copyright] Copyright 2009 John Wiley & Sons, Ltd.
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  • (PMID = 18668698.001).
  • [ISSN] 1099-1069
  • [Journal-full-title] Hematological oncology
  • [ISO-abbreviation] Hematol Oncol
  • [Language] ENG
  • [Grant] United States / NCI NIH HHS / CA / K12 CA087718-09; United States / NCI NIH HHS / CA / CA087718-08; United States / NCI NIH HHS / CA / K12 CA087718-07; United States / NCI NIH HHS / CA / K12 CA087718; United States / NCI NIH HHS / CA / CA087718-09; United States / NCI NIH HHS / CA / CA087718-10; United States / NCI NIH HHS / CA / K12 CA087718-10; United States / NCI NIH HHS / CA / K12 CA087718-08
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Arsenicals; 0 / Oxides; GAN16C9B8O / Glutathione; PQ6CK8PD0R / Ascorbic Acid; S7V92P67HO / arsenic trioxide
  • [Other-IDs] NLM/ NIHMS212975; NLM/ PMC2897137
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9. Hitz F, Martinelli G, Zucca E, von Moos R, Mingrone W, Simcock M, Peterson J, Cogliatti SB, Bertoni F, Zimmermann DR, Ghielmini M, Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland: A multicentre phase II trial of gemcitabine for the treatment of patients with newly diagnosed, relapsed or chemotherapy resistant mantle cell lymphoma: SAKK 36/03. Hematol Oncol; 2009 Sep;27(3):154-9
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  • [Title] A multicentre phase II trial of gemcitabine for the treatment of patients with newly diagnosed, relapsed or chemotherapy resistant mantle cell lymphoma: SAKK 36/03.
  • Mantle cell lymphoma (MCL) has a poor prognosis with often short and incomplete remissions.
  • Eighteen patients with a median age of 70 years were recruited.
  • Fifteen patients had Ann Arbor stage IV.
  • The patient achieving a CR had stage IV disease.
  • Most haematological adverse events occurred during the first chemotherapy cycle.
  • Three patients developed non-haematological serious adverse events: dyspnea, glomerular microangiopathy with haemolytic uremic syndrome (HUS) and hyperglycaemia.
  • The median time-to-progression and treatment response duration (TRD) was 8.0 (95% confidence interval: 5.5, 9.3) and 10.6 (95% confidence interval: 5.5, 10.9) months, respectively.
  • [MeSH-major] Antimetabolites, Antineoplastic / adverse effects. Antimetabolites, Antineoplastic / therapeutic use. Deoxycytidine / analogs & derivatives. Lymphoma, Mantle-Cell / drug therapy

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  • (PMID = 19274614.001).
  • [ISSN] 1099-1069
  • [Journal-full-title] Hematological oncology
  • [ISO-abbreviation] Hematol Oncol
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antimetabolites, Antineoplastic; 0W860991D6 / Deoxycytidine; B76N6SBZ8R / gemcitabine
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10. Longo DL, Duffey PL, Gribben JG, Jaffe ES, Curti BD, Gause BL, Janik JE, Braman VM, Esseltine D, Wilson WH, Kaufman D, Wittes RE, Nadler LM, Urba WJ: Combination chemotherapy followed by an immunotoxin (anti-B4-blocked ricin) in patients with indolent lymphoma: results of a phase II study. Cancer J; 2000 May-Jun;6(3):146-50
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  • [Title] Combination chemotherapy followed by an immunotoxin (anti-B4-blocked ricin) in patients with indolent lymphoma: results of a phase II study.
  • The purpose of this article was to evaluate the antitumor effects of a combination chemotherapy program based on ProMACE (prednisone, methotrexate, doxorubicin [Adriamycin], cyclophosphamide, etoposide) followed by a B cell-specific immunotoxin in the treatment of patients with advanced-stage indolent histology non-Hodgkin's lymphomas.
  • We performed a prospective phase II clinical trial in a referral-based patient population.
  • After confirmation of diagnosis and staging evaluation, 44 patients (10 small lymphocytic lymphoma, 27 follicular lymphoma, 7 mantle cell lymphoma; 30 without prior therapy, 14 previously treated) received six cycles of ProMACE-CytaBOM (cytarabine, bleomycin, vincristine [Oncovin], mechlorethamine) combination chemotherapy (with etoposide given orally daily for five days) followed by a 7-day continuous infusion of anti-B4-blocked ricin immunotoxin at 30 microg/kg/day given every 14 days for up to six cycles.
  • A complete response was achieved in 25 of 44 patients (57%), 21 from the chemotherapy alone, 3 converted from partial to complete response with the immunotoxin, and 1 patient became a complete responder after a surgical procedure to remove an enlarged spleen that was histologically negative for lymphoma.
  • With a median follow-up of 5 years, 14 of 25 complete responders have relapsed (56%); median remission duration was 2 years, and overall survival was 61%.
  • ProMACE-CytaBOM plus anti-B4-blocked ricin does not produce durable complete remissions in the majority of patients with indolent lymphoma.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Antineoplastic Combined Chemotherapy Protocols. Immunoconjugates / therapeutic use. Immunotoxins / therapeutic use. Lymphoma / drug therapy. Ricin / therapeutic use
  • [MeSH-minor] Adult. Aged. Bleomycin / therapeutic use. Cyclophosphamide / therapeutic use. Cytarabine / therapeutic use. Disease-Free Survival. Doxorubicin / therapeutic use. Etoposide / therapeutic use. Female. Humans. Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy. Leukemia, Lymphocytic, Chronic, B-Cell / mortality. Lymphoma, Follicular / drug therapy. Lymphoma, Follicular / mortality. Lymphoma, Mantle-Cell / drug therapy. Lymphoma, Mantle-Cell / mortality. Male. Methotrexate / therapeutic use. Middle Aged. Prednisone / therapeutic use. Time Factors. Treatment Outcome. Vincristine / therapeutic use

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  • [CommentIn] Cancer J. 2000 May-Jun;6(3):135-8 [10882327.001]
  • (PMID = 10882329.001).
  • [ISSN] 1528-9117
  • [Journal-full-title] Cancer journal (Sudbury, Mass.)
  • [ISO-abbreviation] Cancer J
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article
  • [Publication-country] UNITED STATES
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Immunoconjugates; 0 / Immunotoxins; 0 / anti-B4 blocked ricin immunoconjugate; 04079A1RDZ / Cytarabine; 11056-06-7 / Bleomycin; 5J49Q6B70F / Vincristine; 6PLQ3CP4P3 / Etoposide; 80168379AG / Doxorubicin; 8N3DW7272P / Cyclophosphamide; 9009-86-3 / Ricin; VB0R961HZT / Prednisone; YL5FZ2Y5U1 / Methotrexate; PROMACE-CytaBOM protocol
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11. Martens C, Hodgson DC, Wells WA, Sun A, Bezjak A, Pintilie M, Crump M, Gospodarowicz MK, Tsang R: Outcome of hyperfractionated radiotherapy in chemotherapy-resistant non-Hodgkin's lymphoma. Int J Radiat Oncol Biol Phys; 2006 Mar 15;64(4):1183-7
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  • [Title] Outcome of hyperfractionated radiotherapy in chemotherapy-resistant non-Hodgkin's lymphoma.
  • PURPOSE: Patients with chemotherapy-resistant lymphoma have rapidly progressive disease and a poor prognosis.
  • The radiation dose was 39.9-40.5 Gy in 30 fractions.
  • The median treatment time was 22 days with twice-daily involved-field RT.
  • Local control was defined as maintenance of local complete response, complete response-unconfirmed, or lack of local progression with a partial response.
  • The initial diagnosis was Stage I-II in 56% and Stage III-IV in 44%.
  • The histologic features at diagnosis were follicular in 11 (Grade 1 in 4, Grade 2 in 3, and Grade 3 in 4), diffuse large B-cell in 14, peripheral T-cell lymphoma in 2, Burkitt-like in 1, mantle cell in 2, natural killer cell in 2, plasmacytoma/lymphoma in 1, and T-cell lymphoblastic in 1.
  • The initial treatment was chemotherapy in 32 patients (94%); 71% were refractory to initial chemotherapy and 29% developed a relapse after an initial response.
  • [MeSH-major] Lymphoma, Non-Hodgkin / radiotherapy
  • [MeSH-minor] Adult. Aged. Disease Progression. Dose Fractionation. Drug Resistance, Neoplasm. Female. Humans. Male. Middle Aged. Remission Induction. Survivors. Treatment Outcome

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  • (PMID = 16376490.001).
  • [ISSN] 0360-3016
  • [Journal-full-title] International journal of radiation oncology, biology, physics
  • [ISO-abbreviation] Int. J. Radiat. Oncol. Biol. Phys.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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12. Lenz G, Dreyling M, Unterhalt M, Hiddemann W: [Current strategies in the treatment of advanced stage mantle cell lymphoma]. Dtsch Med Wochenschr; 2004 Nov 5;129(45):2429-33
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  • [Title] [Current strategies in the treatment of advanced stage mantle cell lymphoma].
  • [Transliterated title] Aktuelle Therapiestrategien beim fortgeschrittenen Mantelzell-Lymphom.
  • Advanced stage mantle cell lymphoma (MCL) with a median survival of only three years and virtually no long-term survivors represents the lymphoma subtype with the poorest prognosis and remains incurable with conventional chemotherapy.
  • Recently two randomized trials of the German Low Grade Lymphoma Study Group (GLSG) demonstrated the superiority of a combined immunochemotherapy with the anti-CD20 antibody rituximab in first-line therapy (R-CHOP) as well as in relapsed disease (R-FCM).
  • In addition, in a trial of the European MCL Network, intensified-consolidation with high-dose radiochemotherapy followed by autologous stem cell transplantation significantly improved the progression-free survival in patients up to 65 years of age.
  • [MeSH-major] Lymphoma, Mantle-Cell / therapy
  • [MeSH-minor] Age Factors. Aged. Antibodies, Monoclonal / administration & dosage. Antibodies, Monoclonal / therapeutic use. Antibodies, Monoclonal, Murine-Derived. Antineoplastic Agents / administration & dosage. Antineoplastic Agents / therapeutic use. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Clinical Trials, Phase II as Topic. Clinical Trials, Phase III as Topic. Combined Modality Therapy. Cyclophosphamide / therapeutic use. Disease-Free Survival. Doxorubicin / therapeutic use. Female. Humans. Immunotherapy. Male. Middle Aged. Prednisone / therapeutic use. Prognosis. Proteasome Inhibitors. Radiotherapy Dosage. Randomized Controlled Trials as Topic. Recurrence. Risk Factors. Rituximab. Stem Cell Transplantation. Survival Analysis. Time Factors. Transplantation, Autologous. Vincristine / therapeutic use

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  • (PMID = 15529247.001).
  • [ISSN] 0012-0472
  • [Journal-full-title] Deutsche medizinische Wochenschrift (1946)
  • [ISO-abbreviation] Dtsch. Med. Wochenschr.
  • [Language] ger
  • [Publication-type] Comparative Study; English Abstract; Journal Article; Review
  • [Publication-country] Germany
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antibodies, Monoclonal, Murine-Derived; 0 / Antineoplastic Agents; 0 / Proteasome Inhibitors; 4F4X42SYQ6 / Rituximab; 5J49Q6B70F / Vincristine; 80168379AG / Doxorubicin; 8N3DW7272P / Cyclophosphamide; VB0R961HZT / Prednisone; CHOP protocol
  • [Number-of-references] 48
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13. Schüler F, Hirt C, Dölken L, Krüger W, Dölken G: [Minimal residual disease in follicular and mantle cell lymphoma. Detection using quantitative molecular monitoring of circulating lymphoma cells]. Dtsch Med Wochenschr; 2005 Sep 23;130(38):2130-4
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  • [Title] [Minimal residual disease in follicular and mantle cell lymphoma. Detection using quantitative molecular monitoring of circulating lymphoma cells].
  • BACKGROUND AND OBJECTIVE: In patients with follicular lymphoma and mantle cell lymphoma circulating lymphoma cells can be detected by quantitative real-time PCR with a high sensitivity and reproducibility.
  • With this study we wanted to ascertain whether a continuous molecular remission achieved in patients with mantle cell lymphoma and follicular lymphoma has an impact on survival of these patients.
  • PATIENT AND METHODS: We conducted these investigations in 32 patients (24 with follicular lymphoma and 8 with mantle cell lymphoma) who were treated in a randomized trial with chemotherapy plus/minus rituximab (MCP, R-MCP).
  • A further ten patients had follicular lymphoma (stage I and II) in long-term complete remission after radiation therapy.
  • RESULTS: Up to 18 years after initial diagnoses of a stage I or II follicular lymphoma circulating t(14;18) positive cells could be detected in the peripheral blood.
  • In advanced stage follicular lymphoma patients molecular remissions could only be achieved when they were treated with combined chemo-immunotherapy (MCP+R).
  • In contrast, the frustrating clinical results obtained from the treatment of patients with mantle cell lymphoma corresponded to an achievement of only short molecular remissions in very few patients.
  • CONCLUSIONS: The consequent application of quantitative real-time PCR will further improve current treatment strategies in lymphoma patients.
  • Especially, individual treatment options can be developed for patients who do not respond to a standard chemotherapy or progression of disease is recognized, if results of molecular monitoring will be confirmed in large prospective studies.
  • [MeSH-major] Lymphoma, Follicular / pathology. Lymphoma, Mantle-Cell / pathology. Neoplasm, Residual / diagnosis. Neoplastic Cells, Circulating. Polymerase Chain Reaction / methods

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  • (PMID = 16172952.001).
  • [ISSN] 0012-0472
  • [Journal-full-title] Deutsche medizinische Wochenschrift (1946)
  • [ISO-abbreviation] Dtsch. Med. Wochenschr.
  • [Language] ger
  • [Publication-type] English Abstract; Journal Article
  • [Publication-country] Germany
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14. Howard OM, Gribben JG, Neuberg DS, Grossbard M, Poor C, Janicek MJ, Shipp MA: Rituximab and CHOP induction therapy for newly diagnosed mantle-cell lymphoma: molecular complete responses are not predictive of progression-free survival. J Clin Oncol; 2002 Mar 01;20(5):1288-94
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  • [Title] Rituximab and CHOP induction therapy for newly diagnosed mantle-cell lymphoma: molecular complete responses are not predictive of progression-free survival.
  • PURPOSE: To evaluate the efficacy of rituximab and cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) induction therapy in patients with newly diagnosed mantle-cell lymphoma (MCL).
  • PATIENTS AND METHODS: From March 1997 to May 1999, 40 previously untreated patients with stage II through IV MCL were treated with six cycles of rituximab and CHOP chemotherapy in a phase II trial.
  • However, 28 of the 40 patients have already relapsed or developed progressive disease with a median PFS of 16.6 months.
  • Nine of the 25 informative patients had no evidence of PCR-detectable disease in PB or BM after rituximab and CHOP therapy.
  • CONCLUSION: Favorable clinical and molecular response rates associated with rituximab and CHOP chemotherapy do not translate into prolonged PFS in MCL.
  • Nevertheless, rituximab and combination chemotherapy may transiently clear PB or BM of detectable tumor cells, prompting additional consideration of antibody-based in vivo purging in subsequent clinical trials.
  • [MeSH-major] Antibodies, Monoclonal / administration & dosage. Antineoplastic Agents / administration & dosage. Antineoplastic Combined Chemotherapy Protocols / administration & dosage. Cyclophosphamide / administration & dosage. Doxorubicin / administration & dosage. Lymphoma, Mantle-Cell / drug therapy. Prednisolone / administration & dosage. Vincristine / administration & dosage

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  • (PMID = 11870171.001).
  • [ISSN] 0732-183X
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antibodies, Monoclonal, Murine-Derived; 0 / Antineoplastic Agents; 0 / Immunoglobulins; 136601-57-5 / Cyclin D1; 4F4X42SYQ6 / Rituximab; 5J49Q6B70F / Vincristine; 80168379AG / Doxorubicin; 8N3DW7272P / Cyclophosphamide; 9PHQ9Y1OLM / Prednisolone; VAP-cyclo protocol
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15. Fisher RI, Miller TP, O'Connor OA: Diffuse aggressive lymphoma. Hematology Am Soc Hematol Educ Program; 2004;:221-36
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  • [Title] Diffuse aggressive lymphoma.
  • However, there has been great variation in the results reported from individual clinical Phase II trials.
  • Recent clinical and molecular studies have enabled us to define more homogenous population in which new therapies can be studied.
  • For patients with advanced stages of diffuse large B cell lymphoma, a new standard of therapy exists.
  • Finally, in mantle cell lymphoma, new opportunities in drug discovery may permit advances in the treatment of this uniformly fatal malignancy.
  • Richard Fisher reviews the development of combination chemotherapy for patients with advanced stage diffuse large B cell lymphoma.
  • Because of great heterogeneity in patients enrolled in Phase II studies, large randomized Phase III studies were required in the 1980s to define CHOP has the standard of care.
  • Thus CHOP/rituximab has become the established standard of care for all patients with advanced stage diffuse large B cell lymphoma.
  • Other concepts being evaluated to further improve on these results include: dose intensification; initial treatment with chemotherapy plus allogeneic stem cell transplantation; and infusional chemotherapy.
  • Finally, the status of the treatment for relapsed patients will be defined.
  • In Section II, Dr.
  • Thomas Miller defines the treatment for limited stage aggressive non-Hodgkin's lymphoma.
  • Randomized trials have demonstrated the critical importance of initial chemotherapy for treatment of these patients.
  • The amount of chemotherapy given needs to be increased for patients with bulky tumors.
  • In most circumstances radiotherapy after the completion of chemotherapy has been shown to be advantageous.
  • A modification of the international prognostic factor index for patients with early stage disease is presented to permit comparisons among different populations.
  • Recently reported early-stage studies need to be analyzed in terms of the heterogeneity of the patients involved to understand the reported results.
  • Owen O'Connor describes the pathology immunophenotype and natural history of mantle cell lymphoma.
  • Conventional treatment strategies with combination chemotherapy achieved objective responses in approximately half of the patients but no significant impact on survival.
  • The addition to rituximab to CHOP chemotherapy or other treatment strategies appears to improve the remission rate; however, no major changes in survival have also been reported.
  • The most excitement in this field currently relates to the variety of new agents which appear to have significant activity in relapsed patients with mantle cell lymphoma.
  • This includes the proteosome inhibitor, bortezomib, which is shown to have approximately a 50% response rate with some CRs and reasonable durability in early single institution Phase II studies.

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  • (PMID = 15561685.001).
  • [ISSN] 1520-4391
  • [Journal-full-title] Hematology. American Society of Hematology. Education Program
  • [ISO-abbreviation] Hematology Am Soc Hematol Educ Program
  • [Language] ENG
  • [Publication-type] Journal Article; Review
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antibodies, Monoclonal, Murine-Derived; 0 / Antineoplastic Agents; 4F4X42SYQ6 / Rituximab; 5J49Q6B70F / Vincristine; 7S5I7G3JQL / Dexamethasone; 80168379AG / Doxorubicin; 8N3DW7272P / Cyclophosphamide
  • [Number-of-references] 74
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16. Jurczak W, Wywial A, Zaluska A, Pasowicz M, Skotnicki AB: Extranodal masses compressing spinal cord in Hodgkin's disease and follicular lymphoma. J Clin Oncol; 2004 Jul 15;22(14_suppl):6728

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Extranodal masses compressing spinal cord in Hodgkin's disease and follicular lymphoma.
  • In case of low grade lymphomas (like follicular lymphoma - FL) in advanced clinical stage, they may be even less thorough.
  • METHODS/RESULTS: During the last 2 years 3 cases of infiltration of vertebral column (extranodal masses localized within the vertebral canal, compressing but not infiltrating the spinal cord) were diagnosed in over 100 patients treated for HD and FL at that time.
  • In a FL patient they were diagnosed at presentation, while in two HD cases they were found 6 and 9 months after completing the first line therapy, being the cause of early relapse (primary resistance?
  • Radiotherapy -if used in the first line therapy -seems to be a feasible and effective treatment: FL patient is in CR, since IFRT was applied after chemoimmunotherapy (6 cycles of cladribine and cyclophosphamide combined with a standard dose of Rituximab, recycled at day 21); one HD patient treated with 6 cycles of ABVD and Mantle field radiotherapy relapsed evidently below the irradiated field.
  • However both HD cases developed resistance despite second line regimens and high dose chemotherapy supported by autologous stem cell transplant.

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  • (PMID = 28014665.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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17. Rule S, Smith P, Qian W, Gambell J, Curtis N, Johnson P, Linch D: Application of the mantle international prognostic index (MIPI) to patients with mantle cell lymphoma treated with fludarabine/cyclophosphamide: Results from a UK NCRI Lymphoma Group study. J Clin Oncol; 2009 May 20;27(15_suppl):8555

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Application of the mantle international prognostic index (MIPI) to patients with mantle cell lymphoma treated with fludarabine/cyclophosphamide: Results from a UK NCRI Lymphoma Group study.
  • : 8555 Background: Mantle cell lymphoma (MCL) remains an incurable malignancy with conventional chemotherapeutic options with little randomised evidence to help direct therapy.
  • The International Prognostic Index (IPI) for diffuse large cell lymphoma or Follicular Lymphoma International Prognostic Index (FLIPI) showed poor separation of survival curves in MCL patients.
  • A new prognostic index (MIPI) based on age, performance status, lactate dehydrogenase (LDH), and leukocyte count was developed for patients with advanced stage MCL.
  • Data from a randomised phase II NCRI trial designed to assess the effect of adding rituximab to an all oral chemotherapy regimen has been used to validate the MIPI.
  • METHODS: Patients with advanced stage, newly diagnosed MCL were randomised to receive either oral fludarabine 40mg/m<sup>2</sup> and cyclophosphamide 250mg/m<sup>2</sup> daily x 3 repeated every 28 days (FC) or FC with standard dose rituximab (375mg/m<sup>2</sup> on day 1 of every cycle) (FCR).
  • Patients could receive up to 8 cycles of treatment but no consolidation therapy was permitted.
  • Median age 64 (36-88) with a significant male predominance.
  • 117 patients had complete data for calculating the simplified Mantle International Prognostic Index (MIPI) .There was equal distribution between the 3 risk groups (low risk 35%, intermediate risk 33% and high risk 31%).
  • However MIPI does not discriminate for PFS suggesting that those patients with high scores have an inferior response to subsequent therapy post relapse after FC based therapy.

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  • (PMID = 27960988.001).
  • [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. Ruan J, Martin P, Coleman M, Furman R, Glynn P, Joyce M, Cheung K, Shore T, Schuster M, Leonard J: Durable responses with the antiangiogenic metronomic regimen RT-PEPC in elderly patients with recurrent mantle cell lymphoma (MCL). J Clin Oncol; 2009 May 20;27(15_suppl):8525

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Durable responses with the antiangiogenic metronomic regimen RT-PEPC in elderly patients with recurrent mantle cell lymphoma (MCL).
  • : 8525 Background: Targeting tumor microenvironment and angiogenesis is a novel therapeutic strategy in lymphoma.
  • Two putative anti-angiogenic regimens, RT (rituximab with thalidomide) and PEPC oral metronomic chemotherapy (prednisone, etoposide, procarbazine and cyclophosphamide) are clinically active.
  • We report phase II safety, activity, and angiogenic profiling data with the novel combination RT-PEPC in elderly patients with recurrent MCL.
  • Translational studies assessed the angiogenic phenotypes of tumor cells, and dynamic levels of circulating endothelial and hematopoietic progenitors in response to treatment.
  • At study entry, median age (N=25) was 68 yrs (range 52-81), 24 (96%) had stage ≥ III, 16 (64%) had LDH > nl, and 18 (72%) IPI 3-5.
  • The median number of prior therapies was two (range 1 to 7), and 15 pts (60%) progressed on bortezomib.
  • QoL was maintained or improved on treatment.
  • Correlative studies demonstrated pre-therapy autocrine angiogenic loop in tumor cells evidenced by expression of VEGFA and VEGFR1.
  • Novel low-intensity anti-angiogenic approaches warrant further evaluation in MCL and other NHL subtypes, potentially as initial therapy in elderly patients.

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  • (PMID = 27960902.001).
  • [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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19. Witzig TE, Geyer SM, Ghobrial I, Inwards DJ, Fonseca R, Kurtin P, Ansell SM, Luyun R, Flynn PJ, Morton RF, Dakhil SR, Gross H, Kaufmann SH: Phase II trial of single-agent temsirolimus (CCI-779) for relapsed mantle cell lymphoma. J Clin Oncol; 2005 Aug 10;23(23):5347-56
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase II trial of single-agent temsirolimus (CCI-779) for relapsed mantle cell lymphoma.
  • PURPOSE: Mantle cell lymphoma (MCL) is characterized by a t(11;14) resulting in overexpression of cyclin D1 messenger RNA.
  • Patients with a tumor response after six cycles were eligible to continue drug for a total of 12 cycles or two cycles after complete remission, and were then observed without maintenance.
  • The median age was 70 years (range, 38 to 89 years), 91% were stage 4, and 69% had two or more extranodal sites.
  • Patients had received a median of three prior therapies (range, one to 11), and 54% were refractory to the last treatment.
  • The median time-to-progression in all patients was 6.5 months (95% CI, 2.9 to 8.3 months), and the duration of response for the 13 responders was 6.9 months (95% CI, 5.2 to 12.4 months).
  • This study demonstrates that agents that selectively target cellular pathways dysregulated in MCL cells can produce therapeutic benefit.
  • [MeSH-major] Lymphoma, Mantle-Cell / drug therapy. Neoplasm Recurrence, Local / drug therapy. Sirolimus / analogs & derivatives
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Antineoplastic Agents / therapeutic use. Cyclin D1 / metabolism. Disease Progression. Female. Humans. Male. Middle Aged. Ribosomal Protein S6 Kinases / metabolism. Salvage Therapy. Time Factors. Treatment Outcome. Tumor Cells, Cultured

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  • (PMID = 15983389.001).
  • [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 / CA-15083; United States / NCI NIH HHS / CA / CA-25224; United States / NCI NIH HHS / CA / CA-35090; United States / NCI NIH HHS / CA / CA-35101; United States / NCI NIH HHS / CA / CA-35113; United States / NCI NIH HHS / CA / CA-35195; United States / NCI NIH HHS / CA / CA-35267; United States / NCI NIH HHS / CA / CA-35415; United States / NCI NIH HHS / CA / CA-35448; United States / NCI NIH HHS / CA / CA-37404; United States / NCI NIH HHS / CA / CA-60276; United States / NCI NIH HHS / CA / CA-63826; United States / NCI NIH HHS / CA / CA-63848; United States / NCI NIH HHS / CA / CA97274; United States / PHS HHS / / CS-35431
  • [Publication-type] Journal Article; Research Support, N.I.H., Extramural; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 136601-57-5 / Cyclin D1; 624KN6GM2T / temsirolimus; EC 2.7.11.1 / Ribosomal Protein S6 Kinases; W36ZG6FT64 / Sirolimus
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20. Mangel J, Buckstein R, Imrie K, Spaner D, Crump M, Tompkins K, Reis M, Perez-Ordonez B, Deodhare S, Romans R, Pennell N, Robinson JB, Hewitt K, Richardson P, Lima A, Pavlin P, Berinstein NL: Immunotherapy with rituximab following high-dose therapy and autologous stem-cell transplantation for mantle cell lymphoma. Semin Oncol; 2002 Feb;29(1 Suppl 2):56-69
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Immunotherapy with rituximab following high-dose therapy and autologous stem-cell transplantation for mantle cell lymphoma.
  • Advanced-stage mantle cell lymphoma (MCL) is a disease for which no curative treatment strategy exists.
  • Results with standard combination chemotherapy, with or without an anthracycline, are disappointing, and new and better therapies are needed.
  • High-dose therapy and autologous stem-cell transplantation (ASCT) have been performed in patients with MCL both up front and at relapse with varying degrees of success.
  • It has also been used safely and effectively as an in vivo purge during ASCT for patients with lymphoma.
  • We are currently investigating an aggressive protocol in patients with newly diagnosed, untreated MCL using a combination of two promising therapeutic modalities, high-dose therapy-ASCT and rituximab.
  • Since 1999, 13 patients with newly diagnosed MCL have been enrolled in this phase II clinical trial.
  • CHOP (cyclophosphamide/prednisone/vincristine/doxorubicin) is used as debulking chemotherapy.
  • Stem cells are mobilized with 5 days of granulocyte colony-stimulating factor 10 microg/kg/d, with a single infusion of rituximab 375 mg/m(2) used as an in vivo purge before stem-cell collection by large-volume leukapheresis.
  • So far, 12 patients (7 men/5 women) with a median age of 55 years (range, 41 to 65 years) have been transplanted.
  • Patients engrafted quickly, with a median of 11.5 days to neutrophil engraftment and 10 days to platelet independence.
  • Eight patients have received all eight maintenance rituximab treatments, and four have received only their first cycle.
  • With a median follow-up of 239 days from transplant (range, 61 to 727 days), all patients remain alive and well with no documented relapses.
  • Samples for molecular monitoring have been drawn from the stem-cell graft, and serially from the peripheral blood and bone marrow of patients at baseline, preapheresis, pretransplant, and post-transplant at 3-month intervals.
  • Although patient numbers are low and follow-up time is short, preliminary results are encouraging.
  • [MeSH-major] Antibodies, Monoclonal / therapeutic use. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Hematopoietic Stem Cell Transplantation. Lymphoma, Mantle-Cell / therapy
  • [MeSH-minor] Adult. Aged. Antibodies, Monoclonal, Murine-Derived. Antineoplastic Agents / therapeutic use. Chromosomes, Human, Pair 11. Chromosomes, Human, Pair 14. Clinical Trials as Topic. Combined Modality Therapy. Cyclophosphamide / administration & dosage. Doxorubicin / administration & dosage. Female. Genes, bcl-1. Humans. Immunotherapy / methods. Male. Middle Aged. Polymerase Chain Reaction. Prednisone / administration & dosage. Remission Induction. Rituximab. Translocation, Genetic. Transplantation Conditioning. Transplantation, Autologous. Vincristine / administration & dosage

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  • [Copyright] Copyright 2002 by W.B. Saunders Company.
  • (PMID = 11842390.001).
  • [ISSN] 0093-7754
  • [Journal-full-title] Seminars in oncology
  • [ISO-abbreviation] Semin. Oncol.
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't; Review
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antibodies, Monoclonal, Murine-Derived; 0 / Antineoplastic Agents; 4F4X42SYQ6 / Rituximab; 5J49Q6B70F / Vincristine; 80168379AG / Doxorubicin; 8N3DW7272P / Cyclophosphamide; VB0R961HZT / Prednisone; CHOP protocol
  • [Number-of-references] 72
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21. Rosenbluth BD, Yahalom J: Highly effective local control and palliation of mantle cell lymphoma with involved-field radiation therapy (IFRT). Int J Radiat Oncol Biol Phys; 2006 Jul 15;65(4):1185-91
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  • [Title] Highly effective local control and palliation of mantle cell lymphoma with involved-field radiation therapy (IFRT).
  • PURPOSE: Although radiosensitivity of mantle cell lymphoma (MCL) has been demonstrated in vitro, radiotherapy is rarely employed in treatment of MCL.
  • We studied clinical responses of MCL patients treated with involved-field radiation therapy (IFRT) predominantly for local control and/or palliation.
  • Seventeen patients had Stage IV/relapsed disease, 1 had Stage II, and 3 had Stage I disease.
  • Most patients received prior chemotherapy, with an average of two combinations per patient.
  • Mean total dose was 30 Gy.
  • Average time to response was 20 days.
  • Twenty-eight sites had a response before radiation therapy was complete.
  • Thirteen sites (34%) exhibited local progression, with a median time to progression of 10 months, and an average response duration of 9 months.
  • Five patients experienced Grade II radiation-related toxicity.
  • Radiation doses required for most lesions were relatively low and responses were noticed early in the course of treatment.
  • Radiation therapy should be considered early in the course of relapsing, refractory, or localized MCL.
  • [MeSH-major] Lymphoma, Mantle-Cell / radiotherapy
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Female. Humans. Male. Middle Aged. Neoplasm Staging. Palliative Care / methods. Radiotherapy / adverse effects. Retrospective Studies. Survival Analysis

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  • (PMID = 16682133.001).
  • [ISSN] 0360-3016
  • [Journal-full-title] International journal of radiation oncology, biology, physics
  • [ISO-abbreviation] Int. J. Radiat. Oncol. Biol. Phys.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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22. Rueda A, Olmos D, Viciana R, Alba E: Treatment for relapse in stage I/II Hodgkin's lymphoma after initial single-modality treatment. Clin Lymphoma Myeloma; 2006 Mar;6(5):389-92
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  • [Title] Treatment for relapse in stage I/II Hodgkin's lymphoma after initial single-modality treatment.
  • BACKGROUND: Doxorubicin/bleomycin/vinblastine/dacarbazine (ABVD) chemotherapy alone is a viable option for the treatment of stage I/II Hodgkin's lymphoma.
  • Among the main drawbacks for widespread acceptance of this therapy is the absence of available data on the post-salvage therapy course in patients with limited-stage disease who relapse after ABVD.
  • This article focuses on the outcome of 11 limited-stage patients who relapsed after ABVD alone.
  • PATIENTS AND METHODS: After a clinical restaging, the patients received mantle-type radiation therapy (only if patients met these criteria: supradiaphragmatic disease in a single-node area, erythrocyte sedimentation rate < 30 mm per hour, and absence of B symptoms) or conventional salvage chemotherapy followed by high-dose chemotherapy and autologous hematopoietic stem cell transplantation.
  • This experiment entails the series with the longest follow-up in patients with limited-stage Hodgkin's lymphoma who relapsed after ABVD alone.
  • CONCLUSION: The data seem to indicate that salvage therapy is capable of providing cure in most cases and lend further support for the use of ABVD alone as first-line therapy.
  • [MeSH-major] Cause of Death. Hodgkin Disease / drug therapy. Hodgkin Disease / mortality. Neoplasm Recurrence, Local / mortality. Neoplasm Recurrence, Local / therapy. Salvage Therapy
  • [MeSH-minor] Adolescent. Adult. Antineoplastic Combined Chemotherapy Protocols. Bleomycin. Cohort Studies. Combined Modality Therapy. Dacarbazine. Doxorubicin. Female. Hematopoietic Stem Cell Transplantation / adverse effects. Hematopoietic Stem Cell Transplantation / methods. Humans. Male. Neoplasm Staging. Prognosis. Retrospective Studies. Risk Assessment. Survival Analysis. Vinblastine

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  • (PMID = 16640815.001).
  • [ISSN] 1557-9190
  • [Journal-full-title] Clinical lymphoma & myeloma
  • [ISO-abbreviation] Clin Lymphoma Myeloma
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 11056-06-7 / Bleomycin; 5V9KLZ54CY / Vinblastine; 7GR28W0FJI / Dacarbazine; 80168379AG / Doxorubicin; ABVD protocol
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23. Nguyen LN, Ha CS, Hess M, Romaguera JE, Manning JT, Cabanillas F, Cox JD: The outcome of combined-modality treatments for stage I and II primary large B-cell lymphoma of the mediastinum. Int J Radiat Oncol Biol Phys; 2000 Jul 15;47(5):1281-5

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] The outcome of combined-modality treatments for stage I and II primary large B-cell lymphoma of the mediastinum.
  • PURPOSE: Primary mediastinal large B-cell lymphoma (PML) has clinicopathologic features distinct from those of other diffuse large-cell lymphomas.
  • However, the optimal treatment for this tumor is evolving, and in particular, the role of radiation therapy remains undefined.
  • We conducted a retrospective review to evaluate the role of radiation therapy in this disease.
  • METHODS AND MATERIALS: The medical records of 40 consecutive patients with Ann Arbor Stage I or II PML treated at our institution from January 1980 to December 1995 were reviewed.
  • There were 18 patients with Stage I disease and 22 patients with Stage II disease; 62.5% were women and 37.5% were men.
  • The tumor scores were 0 in 1 patient, I in 5 patients, II in 13 patients, III in 7 patients, IV in 4 patients, and unknown in 10 patients.
  • The International Prognostic Index (IPI) was 0 in 10 patients, I in 26 patients, II in 2 patients, and unknown in 2 patients.
  • All patients were treated with doxorubicin-based chemotherapy, and 35 patients received radiation therapy.
  • For most patients who received radiation therapy, an involved field or a modified-mantle field was used, and a dose of 40 Gy in 20 fractions or 39.6 Gy in 22 fractions was administered.
  • Thirty-five patients achieved a complete response; 32 of these patients received radiation therapy.
  • Only 2 of the 5 completed the planned course of radiation therapy; both had massive mediastinal disease.
  • There was no treatment-related death from the initial chemotherapy or radiation therapy.
  • One patient developed a second malignancy (sarcoma) within the radiation field after 13 years.
  • CONCLUSION: We recommend consolidative radiation therapy in view of the excellent local control and the lack of significant toxicity.
  • Modified mantle or involved field appears to be an adequate volume, and 39.6-40 Gy appears to be an adequate dose.
  • [MeSH-major] Lymphoma, B-Cell / drug therapy. Lymphoma, B-Cell / radiotherapy. Lymphoma, Large B-Cell, Diffuse / drug therapy. Lymphoma, Large B-Cell, Diffuse / radiotherapy
  • [MeSH-minor] Adolescent. Adult. Aged. Analysis of Variance. Combined Modality Therapy. Female. Hematopoietic Stem Cell Transplantation. Humans. Male. Middle Aged. Neoplasm Staging. Recurrence. Retrospective Studies. Treatment Outcome

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  • (PMID = 10889382.001).
  • [ISSN] 0360-3016
  • [Journal-full-title] International journal of radiation oncology, biology, physics
  • [ISO-abbreviation] Int. J. Radiat. Oncol. Biol. Phys.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] UNITED STATES
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24. Barreda B F, Gómez P R, Quispe L D, Sánchez L J, Combe G J, Casanova M L, Celis Z J: [Primary gastric lymphoma]. Rev Gastroenterol Peru; 2004 Jul-Sep;24(3):238-62
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] [Primary gastric lymphoma].
  • [Transliterated title] Linfoma gastrico primario.
  • INTRODUCTION: Primary Gastric Lymphoma is an uncommon malignancy among gastric malignancies.
  • Histology of the Primary Gastric Lymphoma is varied and the extranodal marginal zone B-cells lymphoma is specially significant on account of its potential remission with antibiotic therapy.
  • OBJECTIVES: Observe the clinical characteristics of patients with Primary Gastric Lymphoma, assess the most relevant endoscopic findings, identify the factors that influence survival and evaluate the effects of therapy.
  • MATERIALS AND METHODS: The study is an observational, analytical, cross evaluation including 169 patients with histological diagnosis of Gastric Lymphoma, treated at the National Institute for Neoplastic Diseases, Lima, Peru, from January 1995 to December 2000.
  • RESULTS: The sample represents patients from the Peruvian Coast, with a mean age of 55 years old and slight predominance of female patients (54.4%).
  • Clinical stage I-II corresponds to 75% of the patients.
  • The endoscopic pattern of multiple ulcerated lesions is characteristic of the Gastric Lymphoma.
  • A total of 71% of the patients with extranodal marginal zone B-cells lymphoma showed total remission of the disease with antibiotic therapy (5/7).
  • The histological type of the Gastric Lymphoma in the 169 patients was as follows: Large, diffuse, B-cells Lymphoma, 137 patients, extranodal marginal zone B-cells lymphoma, 16 patients, peripheral T-cell Lymphoma, 6 patients, anaplastic large T-cell Lymphoma, 3 patients, undetermined Lymphoma, 3 patients, mantle cell Lymphoma, 2 patients, adult T-cell Lymphoma, 1 patient and follicular Lymphoma, 1 patient.
  • Global survival after 36 months was of 61.34%, survival according to the histological type was of 92.31% for extranodal marginal zone B-cells Lymphomas, 62.21% for large, diffuse B-cells Lymphomas and 29.63% for T-cell Lymphomas.
  • Survival after 36 months in patients in clinical stage I-II treated with chemotherapy, was of 82.16%, with surgery, 71.89% and with surgery and chemotherapy, 70.39, with similar results in all three groups (p: 0.6530).
  • The univariate analysis revealed that Zubrod (p:0.0000) DHL (p:0.0073) disease remission (p:0.0000) stage (p:0.0000) treatment (p:0.0000) and location (p:0.0000) had statistical significance.
  • CONCLUSIONS: The multiple ulcerated lesions are characteristic of the Gastric Lymphoma.
  • Remission of the disease in the extranodal marginal zone B-cells Lymphoma is evidenced with the use of antibiotic therapy (5/7).
  • Chemotherapy in patients with EC I-II achieves survival results similar to those treated with surgery and with a combination of both.
  • [MeSH-major] Lymphoma, B-Cell, Marginal Zone / pathology. Stomach Neoplasms / pathology

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  • (PMID = 15483686.001).
  • [ISSN] 1022-5129
  • [Journal-full-title] Revista de gastroenterología del Perú : órgano oficial de la Sociedad de Gastroenterología del Perú
  • [ISO-abbreviation] Rev Gastroenterol Peru
  • [Language] spa
  • [Publication-type] Comparative Study; English Abstract; Journal Article; Review
  • [Publication-country] Peru
  • [Number-of-references] 102
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25. Weide R, Hess G, Köppler H, Heymanns J, Thomalla J, Aldaoud A, Losem C, Schmitz S, Haak U, Huber C, Unterhalt M, Hiddemann W, Dreyling M, German Low Grade Lymphoma Study Group: High anti-lymphoma activity of bendamustine/mitoxantrone/rituximab in rituximab pretreated relapsed or refractory indolent lymphomas and mantle cell lymphomas. A multicenter phase II study of the German Low Grade Lymphoma Study Group (GLSG). Leuk Lymphoma; 2007 Jul;48(7):1299-306
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  • [Title] High anti-lymphoma activity of bendamustine/mitoxantrone/rituximab in rituximab pretreated relapsed or refractory indolent lymphomas and mantle cell lymphomas. A multicenter phase II study of the German Low Grade Lymphoma Study Group (GLSG).
  • On the basis of a preceding phase I study, the current trial explored bendamustine in combination with mitoxantrone and rituximab (BMR) in patients with stage III/IV relapsed or refractory indolent lymphomas and mantle cell lymphoma (MCL) with or without prior rituximab containing chemo-immunotherapy (R-chemo) treatment.
  • Therapy consisted of bendamustine 90 mg/m(2) days 1 + 2, mitoxantrone 10 mg/m(2) day 1, rituximab 375 mg/m(2) day 8.
  • Treatment was repeated on day 29 for a total of four cycles.
  • Between 3 April and 04 July, 57 patients were recruited from 24 participating institutions, 39% of whom had received prior R-chemo therapy.
  • Lymphoma subtypes were 29 follicular (FL), 18 MCL, and 10 other indolent lymphomas.
  • After a median observation time of 27 months (1 - 43), the estimated median progression free survival is 19 months.
  • Treatment related toxicities of grade 3/4 comprised a reversible myelosuppression (10% anemia, 78% leukocytopenia, 46% granulocytopenia, 16% thrombocytopenia).
  • BMR is a very effective new outpatient immuno-chemotherapy with low toxicity for patients with relapsed/refractory FL, MCL and other indolent lymphomas.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Lymphoma, Mantle-Cell / drug therapy. Lymphoma, Non-Hodgkin / drug therapy. Nitrogen Mustard Compounds / administration & dosage
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Antibodies, Monoclonal / administration & dosage. Antibodies, Monoclonal, Murine-Derived. Bendamustine Hydrochloride. Female. Humans. Lymphoma, Follicular / complications. Lymphoma, Follicular / drug therapy. Lymphoma, Follicular / mortality. Male. Middle Aged. Mitoxantrone / administration & dosage. Remission Induction. Rituximab. Salvage Therapy / methods. Survival Analysis. Treatment Outcome

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  • [CommentIn] Leuk Lymphoma. 2007 Jul;48(7):1264-6 [17613752.001]
  • (PMID = 17613757.001).
  • [ISSN] 1042-8194
  • [Journal-full-title] Leukemia & lymphoma
  • [ISO-abbreviation] Leuk. Lymphoma
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study
  • [Publication-country] England
  • [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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26. Garbo LE, Flynn PJ, MacRae MA, Rauch MA, Wang Y, Kolibaba KS: Results of a Phase II trial of gemcitabine, mitoxantrone, and rituximab in relapsed or refractory mantle cell lymphoma. Invest New Drugs; 2009 Oct;27(5):476-81
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Results of a Phase II trial of gemcitabine, mitoxantrone, and rituximab in relapsed or refractory mantle cell lymphoma.
  • BACKGROUND: Gemcitabine (G) has shown activity in mantle cell lymphoma (MCL) as a single agent.
  • PATIENTS AND METHODS: Sixteen patients were enrolled between April 2005 and January 2007, 88% had Stage IV MCL, Median patient age was 74 years.
  • Median survival and PFS have not been reached with a median follow-up of 10.7 months.
  • The study was closed early due to slow accrual owing to an alternative treatment which became available at the time.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Lymphoma, Mantle-Cell / drug therapy. Neoplasm Recurrence, Local / drug therapy
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Antibodies, Monoclonal / administration & dosage. Antibodies, Monoclonal, Murine-Derived. Deoxycytidine / administration & dosage. Deoxycytidine / analogs & derivatives. Female. Humans. Male. Middle Aged. Mitoxantrone / administration & dosage. Neoplasm Staging. Prognosis. Prospective Studies. Rituximab. Salvage Therapy. Survival Rate. Treatment Outcome

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  • (PMID = 18953490.001).
  • [ISSN] 1573-0646
  • [Journal-full-title] Investigational new drugs
  • [ISO-abbreviation] Invest New Drugs
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antibodies, Monoclonal, Murine-Derived; 0W860991D6 / Deoxycytidine; 4F4X42SYQ6 / Rituximab; B76N6SBZ8R / gemcitabine; BZ114NVM5P / Mitoxantrone
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27. Koenigsmann M, Knauf W, Herold M, Pasold R, Müller G, Eschenburg H, Kahl C, Lakner V, Assmann M, Jentsch-Ullrich K, Mohren M, Bartsch R, Franke A: Fludarabine and bendamustine in refractory and relapsed indolent lymphoma--a multicenter phase I/II Trial of the east german society of hematology and oncology (OSHO). Leuk Lymphoma; 2004 Sep;45(9):1821-7
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  • [Title] Fludarabine and bendamustine in refractory and relapsed indolent lymphoma--a multicenter phase I/II Trial of the east german society of hematology and oncology (OSHO).
  • The therapy of patients with relapsed or refractory indolent lymphoma relies on the development of new drug combinations.
  • The drugs bendamustine and fludarabine have cytotoxic activity as monotherapy in indolent lymphoma and show synergism in vitro.
  • In this study, we combined both drugs in a multicenter clinical phase I/II trial to evaluate their toxicity and efficacy.
  • Bendamustine was given at 30 or 40 mg/m2/d (dose levels 1 and 2), fludarabine at 30 mg/m2/d, each drug on days 1 to 3.
  • A total of 29 patients with relapsed or refractory indolent lymphoma were included in the study.
  • Thirteen patients were added to the study during phase II.
  • Fourteen patients had follicular lymphoma, 11 patients mantle cell lymphoma, 2 patients lymphoplasmocytic and 2 patients nodal marginal zone lymphoma.
  • All patients were in stages III or IV of their disease and had received prior chemotherapy with or without additional radio- or immunotherapy.
  • The study was continued at dose level 1 (phase II).
  • Nine of 9 patients with mantle cell lymphoma responded to therapy.
  • Eight of 15 responders relapsed after a median follow-up time of 14 months (range 2-43).
  • Dose level 1 with 30 mg/m2/d of both drugs on days 1 to 3 was defined as the recommended dose.
  • Despite unfavorable prognostic features (histologic subtype, stage of disease, pretreatment) response rates were good with this regimen.
  • [MeSH-major] Hematology. Lymphoma / drug therapy. Lymphoma / pathology. Medical Oncology. Nitrogen Mustard Compounds / therapeutic use. Societies, Medical. Vidarabine / analogs & derivatives. Vidarabine / therapeutic use
  • [MeSH-minor] Adult. Aged. Bendamustine Hydrochloride. Female. Germany. Humans. Male. Middle Aged. Neoplasm Staging. Recurrence. Remission Induction. Time Factors

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  • [Copyright] Copyright 2004 Taylor and Francis Ltd
  • (PMID = 15223642.001).
  • [ISSN] 1042-8194
  • [Journal-full-title] Leukemia & lymphoma
  • [ISO-abbreviation] Leuk. Lymphoma
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article; Multicenter Study
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Nitrogen Mustard Compounds; 981Y8SX18M / Bendamustine Hydrochloride; FA2DM6879K / Vidarabine; P2K93U8740 / fludarabine
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28. Chi Y, Chen CM: Curtailed two-stage designs in Phase II clinical trials. Stat Med; 2008 Dec 20;27(29):6175-89
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  • [Title] Curtailed two-stage designs in Phase II clinical trials.
  • When the accrual rate is low and the treatment period is long, a long observational period is required before information concerning the primary end point, such as binary response, becomes available in the study.
  • Simon's two-stage designs are often employed in Phase II clinical trials to avoid giving patient an ineffective drug.
  • Thus, if the new drug is ineffective then this design would certainly accelerate the process of drug discovery and development.
  • However, for a promising new drug this design may still require a long observational period.
  • Therefore, when drug safety is not a primary concern, this paper proposes curtailed two-stage designs to shorten the drug development process as soon as the treatment either shows lack of efficacy or is very effective.
  • The proposed design is superior to Simon's two-stage designs in terms of savings in expected sample size and is much easier to implement in practice than stochastically curtailed Simon's designs.
  • [MeSH-major] Biometry / methods. Clinical Trials, Phase II as Topic / statistics & numerical data
  • [MeSH-minor] Antineoplastic Agents / adverse effects. Antineoplastic Agents / therapeutic use. Drug Discovery / statistics & numerical data. Etoposide / adverse effects. Etoposide / therapeutic use. Humans. Lymphoma, Mantle-Cell / drug therapy. Models, Statistical. Sarcoma, Kaposi / drug therapy. Stochastic Processes. Treatment Outcome

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  • (PMID = 18816510.001).
  • [ISSN] 1097-0258
  • [Journal-full-title] Statistics in medicine
  • [ISO-abbreviation] Stat Med
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 6PLQ3CP4P3 / Etoposide
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29. Aghajanian C, Blessing JA, Darcy KM, Reid G, DeGeest K, Rubin SC, Mannel RS, Rotmensch J, Schilder RJ, Riordan W, Gynecologic Oncology Group: A phase II evaluation of bortezomib in the treatment of recurrent platinum-sensitive ovarian or primary peritoneal cancer: a Gynecologic Oncology Group study. Gynecol Oncol; 2009 Nov;115(2):215-20
Hazardous Substances Data Bank. BORTEZOMIB .

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  • [Title] A phase II evaluation of bortezomib in the treatment of recurrent platinum-sensitive ovarian or primary peritoneal cancer: a Gynecologic Oncology Group study.
  • PATIENTS AND METHODS: Eligible women with recurrent EOC/PPC progressing between 6 and 12 months after initial chemotherapy were treated with bortezomib on days 1, 4, 8, and 11 [1.5 (cohort I) and 1.3 (cohort II) mg/m(2)/dose].
  • Patients must have had initial chemotherapy only.
  • Response Evaluation Criteria in Solid Tumors (RECIST) was assessed by computed tomography (CT) scan every 2 cycles.
  • 20S proteasome activity was quantified in three pre-treatment and a 1-hour post-treatment (cycle one, day 1) whole blood lysates.
  • Given concerns that treatment discontinuations due to toxicity limited drug exposure/activity a second cohort of 29 evaluable patients was accrued at 1.3 mg/m(2)/dose.
  • The 1.3 mg/m(2)/dose regimen is currently approved as an indication for multiple myeloma and mantle cell lymphoma.
  • Treatment was more tolerable, although objective responses remained low at 6.9% (2/29, partial responses).
  • Second stage accrual was not warranted at either dose.
  • Bortezomib effectively inhibited 20S proteasome activity in whole blood lysates between 37 and 92% in 24/25 (96%) patients in cohort I, and 14-84% in 27/28 (96%) patients in cohort II who provided satisfactory pre- and post-treatment specimens for testing.
  • CONCLUSION: Bortezomib has minimal activity as a single-agent in the treatment of recurrent platinum-sensitive EOC/PPC.
  • Treatment with bortezomib at 1.5 mg/m(2)/dose was not feasible in this patient population due to excess toxicity.
  • [MeSH-major] Boronic Acids / therapeutic use. Neoplasm Recurrence, Local / drug therapy. Ovarian Neoplasms / drug therapy. Peritoneal Neoplasms / drug therapy. Pyrazines / therapeutic use
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Antineoplastic Agents / adverse effects. Antineoplastic Agents / pharmacokinetics. Antineoplastic Agents / therapeutic use. Bortezomib. Cohort Studies. Female. Humans. Middle Aged. Protease Inhibitors / adverse effects. Protease Inhibitors / therapeutic use. Proteasome Endopeptidase Complex / metabolism. Young Adult

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  • (PMID = 19712963.001).
  • [ISSN] 1095-6859
  • [Journal-full-title] Gynecologic oncology
  • [ISO-abbreviation] Gynecol. Oncol.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / CA 11479; United States / NCI NIH HHS / CA / CA 37517; United States / NCI NIH HHS / CA / CA27469
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Boronic Acids; 0 / Protease Inhibitors; 0 / Pyrazines; 69G8BD63PP / Bortezomib; EC 3.4.25.1 / Proteasome Endopeptidase Complex
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30. 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.
  • Beginning with initiation of treatment recurrent profound leukopenia became evident in 13 out of 16 patients leading to treatment discontinuation.
  • Therefore, we developed a steroid co-medication regimen for the first 4 Campath-1H applications with quick tapering thereafter.
  • Following this regimen, no infusion associated side effects WHO grade > II were observed.
  • Infectious complications leading to treatment discontinuation consisted of pulmonary aspergillosis in one and bacterial pneumonia in another case.
  • 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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31. Medvedev PV, Nikitin EA, Pivnik AV: [The therapeutic efficacy and toxicity of the liposomal form of daunorubicin (Daunoxome) in lymphosarcoma patients]. Ter Arkh; 2000;72(7):38-42
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  • [Title] [The therapeutic efficacy and toxicity of the liposomal form of daunorubicin (Daunoxome) in lymphosarcoma patients].
  • AIM: To evaluate toxicity and efficacy of CDxOP regimen in the treatment of primary non-Hodgkin's lymphoma (PNHL).
  • MATERIAL AND METHODS: The study included 8 males and 6 females who had large B-cell lymphoma (n = 11), follicular lymphoma, predominantly large cell (n = 1), mantle cell lymphoma (n = 1) and peripheral T-cell lymphoma (n = 1).
  • PNHL stage IV, III and II was diagnosed in 7, 5 and 2 patients, respectively.
  • The other drugs were used in standard doses.
  • Three patients did not respond to therapy and died.
  • The results of the treatment are comparable with those of standard chemotherapy.
  • Further comparative studies are needed for determination of efficacy and maximal tolerated dose of daunoxome in combination with other drugs and irradiation, of long-term side effects.
  • This drug may be beneficial for elderly patients.
  • [MeSH-major] Antibiotics, Antineoplastic / administration & dosage. Daunorubicin / administration & dosage. Lymphoma, Non-Hodgkin / drug therapy
  • [MeSH-minor] Adolescent. Adult. Aged. Aged, 80 and over. Antineoplastic Combined Chemotherapy Protocols / adverse effects. Cyclophosphamide / administration & dosage. Cyclophosphamide / adverse effects. Dose-Response Relationship, Drug. Doxorubicin / administration & dosage. Doxorubicin / adverse effects. Female. Heart / drug effects. Humans. Liposomes. Male. Middle Aged. Prednisone / administration & dosage. Prednisone / adverse effects. Remission Induction. Time Factors. Vincristine / administration & dosage. Vincristine / adverse effects

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  • (PMID = 10983319.001).
  • [ISSN] 0040-3660
  • [Journal-full-title] Terapevticheskiĭ arkhiv
  • [ISO-abbreviation] Ter. Arkh.
  • [Language] rus
  • [Publication-type] Clinical Trial; English Abstract; Journal Article
  • [Publication-country] RUSSIA
  • [Chemical-registry-number] 0 / Antibiotics, Antineoplastic; 0 / Liposomes; 5J49Q6B70F / Vincristine; 80168379AG / Doxorubicin; 8N3DW7272P / Cyclophosphamide; VB0R961HZT / Prednisone; ZS7284E0ZP / Daunorubicin; CHOP protocol
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32. Rizzieri DA, Feldman E, Dipersio JF, Gabrail N, Stock W, Strair R, Rivera VM, Albitar M, Bedrosian CL, Giles FJ: A phase 2 clinical trial of deforolimus (AP23573, MK-8669), a novel mammalian target of rapamycin inhibitor, in patients with relapsed or refractory hematologic malignancies. Clin Cancer Res; 2008 May 1;14(9):2756-62
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  • A Simon two-stage design was used for each cohort.
  • RESULTS: Fifty-five patients received deforolimus as follows: cohort 1 23 acute myelogenous leukemia, two myelodysplastic syndrome and one chronic myelogenous leukemia in nonlymphoid blast phase; cohort 2, one acute lymphocytic leukemia; cohort 3, nine agnogenic myeloid metaplasia; cohort 4, eight chronic lymphocytic leukemia; cohort 5, nine mantle cell lymphoma and two T-cell leukemia/lymphoma.
  • Of the 52 evaluable patients, partial responses were noted in five (10%), two of seven agnogenic myeloid metaplasia and three of nine mantle cell lymphoma.
  • Common treatment-related adverse events, which were generally mild and reversible, were mouth sores, fatigue, nausea, and thrombocytopenia.
  • Decreased levels of phosphorylated 4E-BP1 in 9 of 11 acute myelogenous leukemia/myelodysplastic syndrome patients after therapy showed mammalian target of rapamycin inhibition by deforolimus.
  • Further investigation of deforolimus alone and in combination with other therapeutic agents is warranted in patients with selected hematologic malignancies.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Hematologic Neoplasms / drug therapy. Sirolimus / analogs & derivatives. Vascular Endothelial Growth Factor A / blood

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  • (PMID = 18451242.001).
  • [ISSN] 1078-0432
  • [Journal-full-title] Clinical cancer research : an official journal of the American Association for Cancer Research
  • [ISO-abbreviation] Clin. Cancer Res.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / VEGFA protein, human; 0 / Vascular Endothelial Growth Factor A; 48Z35KB15K / ridaforolimus; W36ZG6FT64 / Sirolimus
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33. Lenz G, Dreyling M: Does the combination of rituximab and thalidomide influence the long-term perspectives of advanced-stage MCL? Nat Clin Pract Oncol; 2005 Feb;2(2):72-3
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  • [Title] Does the combination of rituximab and thalidomide influence the long-term perspectives of advanced-stage MCL?
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Lymphoma, Mantle-Cell / drug therapy
  • [MeSH-minor] Aged. Antibodies, Monoclonal / administration & dosage. Antibodies, Monoclonal, Murine-Derived. Female. Humans. Male. Middle Aged. Rituximab. Stem Cell Transplantation. Thalidomide / administration & dosage. Treatment Outcome

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  • (PMID = 16264875.001).
  • [ISSN] 1743-4254
  • [Journal-full-title] Nature clinical practice. Oncology
  • [ISO-abbreviation] Nat Clin Pract Oncol
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antibodies, Monoclonal, Murine-Derived; 4F4X42SYQ6 / Rituximab; 4Z8R6ORS6L / Thalidomide
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