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Sponsors and Collaborators: |
European Mantle Cell Lymphoma Network German Low Grade Lymphoma Study Group Groupe d'Etudes de Lymphomes de L'Adulte HOVON - Dutch Haemato-Oncology Association Nordic Lymphoma Group |
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Information provided by: | European Mantle Cell Lymphoma Network |
ClinicalTrials.gov Identifier: | NCT00209209 |
The aim of this study is to answer the following independent questions in the treatment of mantle cell lymphomas:
Condition | Intervention | Phase |
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Lymphoma, Mantle-Cell |
Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisone Drug: Fludarabine Drug: Interferon-alpha Drug: pegylated formula Interferon-alpha 2b Procedure: chemotherapy: R-CHOP Procedure: chemotherapy: R-FC Procedure: Interferon maintenance Procedure: Rituximab maintenance |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Efficacy of Maintenance Therapy With Rituximab After Induction Chemotherapy (R-CHOP vs. R-FC) for Elderly Patients With Mantle Cell Lymphoma Not Suitable for Autologous Stem Cell Transplantation |
Estimated Enrollment: | 570 |
Study Start Date: | January 2004 |
Estimated Study Completion Date: | January 2014 |
Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
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Drug: Rituximab
antibody
Drug: Cyclophosphamide
chemotherapy
Drug: Doxorubicin
chemotherapy
Drug: Vincristine
chemotherapy
Drug: Prednisone
coricosteroide
Drug: Interferon-alpha
cytokine
Drug: pegylated formula Interferon-alpha 2b
cytokine
Procedure: chemotherapy: R-CHOP
immuno-chemotherapy
Procedure: Interferon maintenance
cytokine
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2: Experimental
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Drug: Rituximab
antibody
Drug: Cyclophosphamide
chemotherapy
Drug: Fludarabine
chemotherapy
Procedure: chemotherapy: R-FC
immuno-chemotherapy
Procedure: Rituximab maintenance
antibody
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This study investigates two independent questions in the treatment of elderly patients with mantle cell lymphomas:
This study will be performed as a prospective, randomized, open-label multicenter phase III trial. All patients will be randomized for an initial cytoreductive therapy with R-FC or R-CHOP.
The parameter for the comparison of R-FC and R-CHOP will be the percentage of complete remissions after initial cytoreductive therapy. According to the known results of R-FC and R-CHOP in lymphoma therapy, a relevant difference between R-CHOP and R-FC in the overall response rates is not expected. For both therapies an overall response rate of about 90% is expected. Since it is well known that the prognosis of patients who do not reach at least a PR in the initial therapy is very poor, it will be also necessary to control this parameter during the study. If an unexpected relevant difference in the overall response rates is observed during the study, the initial randomisation should be stopped and all patients should be assigned to the superior therapy. In this case the CR rates will not be important for the choice of the initial therapy. If no relevant differences in the overall response rates are observed, a one sided Fisher test will be performed at the end of the recruitment to test whether the rate of CR's after R-FC is significantly improved compared to R-CHOP.
The statistical parameters for controlling the overall response rates and for testing the CR rates are chosen in the following way: The working significance level for all statistical evaluations in this part of the study will be set to alpha=0.05. The expected CR rate after R-CHOP is according to the observations about 50%; a clinical relevant improvement by R-FC would be a CR rate of 65%. Such an improvement should be detected by the one sided Fisher test with a power of about 95%. According to these parameters about 246 observations for each treatment would be necessary. To control the overall response rates, a difference of 85% to 95% will be clinically so relevant that initial randomisation should be terminated with a probability of about 95%. Overall response rates will be controlled by a restricted sequential procedure.
Patients achieving at least a partial remission after R-FC or R-CHOP will be randomised for interferon maintenance versus rituximab maintenance in order to evaluate the impact of maintenance therapy in progression free survival.
The improvement expected by the new maintenance with rituximab for progression free survival can be expressed by reduction of relative risk (rr). Since a risk reduction to 60% was observed for indolent lymphomas by interferon maintenance, this seems to be a clinical relevant improvement for the new maintenance therapy. For a working significance level alpha=0.05 and a power of 95% the number of events (relapse or death) necessary for a two sided fixed sample trial is about 200. During this study the progression free survival in patients after successful initial therapy will be monitored by an equivalent restricted sequential procedure with a maximum number of 240 observation.
In order to evaluate the impact of initial therapy and maintenance therapy on overall survival in this patients, a total follow up of about 15 years for this study is expected.
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michael Unterhalt, Dr. | +49-89-7095 ext 4915 | Michael.Unterhalt@med.uni-muenchen.de |
Contact: Martin Dreyling, PhD | +49-89-7095 ext 2202 | Martin.Dreyling@med.uni-muenchen.de |
Czech Republic | |
General University Hospital, 1ST Department of Medicine | Recruiting |
PRAHA, Czech Republic, CZ-12808 | |
Contact: Marek Trnény, MD 0042-2-2496-2061 trneny@cesnet.cz | |
Principal Investigator: Marek Trnény, MD | |
Denmark | |
Nordic Lymphoma Group | Recruiting |
COPENHAGEN, Denmark, DK-2100 | |
Contact: Christian Geisler, MD +45-3545-1146 geisler@rh.dk | |
Principal Investigator: Christian Geisler, MD | |
France | |
Groupe D´Etudes des Lymphomes De l´Adulte (GELA) | Recruiting |
Paris, France, F-75743 | |
Contact: Guylène Chartier +33-1-42499811 Guylene.chartier@chu-stlouis.fr | |
Contact: Olivier Hermine, PhD +33-1-44 49 52 83 hermine@necker.fr | |
Principal Investigator: Olivier Hermine, PhD | |
Germany | |
German Low Grade Study Group (Glsg) | Recruiting |
Munich, Germany, D-81377 | |
Contact: Michael Unterhalt, Dr. +49-89-7095 ext 4915 Michael.Unterhalt@med.uni-muenchen.de | |
Contact: Martin Dreyling, PhD +49-89-7095 ext 2202 Martin.Dreyling@med.uni-muenchen.de | |
Principal Investigator: Martin Dreyling, PhD | |
Italy | |
Ospedale Ferratotto, Divisione Di Ematologia | Recruiting |
CATANIA, Italy, I-95124 | |
Contact: Francesco Di Raimondo, PhD +39-095-7435911 | |
Principal Investigator: Francesco Di Raimondo, PhD | |
Netherlands | |
HOVON - Dutch Haemato-Oncology Association (HOVON-Datacenter) | Recruiting |
Rotterdam, Netherlands, NL-3008 AE | |
Contact: Christel van Hooije +31-10-4391568 | |
Contact: Hanneke C. Kluin-Nelemans, PhD +31-50-3612354 j.c.kluin.nelemans@int.azg.nl | |
Principal Investigator: Hanneke C. Kluin-Nelemans, PhD | |
Poland | |
the Maria Sklodowska Memorial, Cancer Center - Inst. of Oncology | Recruiting |
WARSZAWA, Poland, PL-02-781 | |
Contact: Jan Walewski, MD +48-22-546-2223 walewski@coi.waw.pl | |
Contact: Marek P Nowacki, MD +48-22-546-2223 | |
Principal Investigator: Jan Walewski, MD |
Principal Investigator: | Hanneke C. Kluin-Nelemans, PhD | University Hospital Groningen, Dept. of Hematology |
Study Chair: | Martin Dreyling, PhD | University Hospital Grosshadern/LMU, Dept. of Medicine III |
Responsible Party: | University Hospital Grosshadern/European MCL Network ( Prof. Dr. Martin Dreyling ) |
Study ID Numbers: | MCL2004-1 |
Study First Received: | September 13, 2005 |
Last Updated: | July 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00209209 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Lymphoma, Mantle-Cell Elderly patients Chemotherapy Maintenance therapy |
C04.557.386.480.300.725.500 C15.604.515.569.480.300.725.500 C20.683.515.761.480.300.725.500 |
Anti-Inflammatory Agents Prednisone Anti-Infective Agents Immunologic Factors Hormone Antagonists Lymphoma, Mantle-Cell Hormones, Hormone Substitutes, and Hormone Antagonists Mantle Cell Lymphoma Cyclophosphamide Hormones Anti-Bacterial Agents Alkylating Agents Lymphoma Immunoglobulins Interferon-alpha |
Immunoproliferative Disorders Antineoplastic Agents, Hormonal Rituximab Interferons Vincristine Antimitotic Agents Fludarabine monophosphate Glucocorticoids Antiviral Agents Angiogenesis Inhibitors Immunosuppressive Agents Doxorubicin Lymphatic Diseases Antibodies Tubulin Modulators |
Anti-Inflammatory Agents Prednisone Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Lymphoma, Mantle-Cell Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Cyclophosphamide Antibiotics, Antineoplastic Hormones Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |
Alkylating Agents Lymphoma Interferon-alpha Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Rituximab Growth Substances Mitosis Modulators Interferons Vincristine Antimitotic Agents Glucocorticoids Immunosuppressive Agents |