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Sponsored by: |
Swiss Group for Clinical Cancer Research |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003280 |
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known which treatment regimen is more effective for lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of rituximab in treating patients who have follicular or mantle cell lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: rituximab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | A Randomized, Phase III Trial to Determine the Effect of Consolidation With Rituximab (IDEC C2B8-Mabthera) in Patients With CD20+ Follicular or Mantle Cell Lymphoma Having Received Induction Therapy With Rituximab Weekly x 4 |
Estimated Enrollment: | 240 |
Study Start Date: | January 1998 |
OBJECTIVES:
OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to participating center, histology (follicular (closed to accrual 9/18/00) vs mantle cell), status of disease (de novo vs relapsed vs resistant), response after induction (stable disease vs partial or complete response), and treatment status (treated vs untreated).
All patients receive induction therapy consisting of rituximab IV over 3-5 hours once a week during weeks 1-4. Patients are then randomized to one of two treatment arms.
Patients are followed weekly for the first month; every 8 weeks for the next 8 months; then at 12, 18, and 24 months; and then annually for the next 3 years.
PROJECTED ACCRUAL: A total of 240 patients (120 per arm) will be accrued for this study within 3-4 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven CD20 positive follicular (closed to accrual 9/18/00) or mantle cell lymphoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Switzerland | |
Burgerspital, Solothurn | |
Solothurn, Switzerland, 4500 | |
City Hospital Triemli | |
Zurich, Switzerland, 8063 | |
Hopital Cantonal Universitaire de Geneva | |
Geneva, Switzerland, CH-1211 | |
Inselspital, Bern | |
Bern, Switzerland, CH-3010 | |
Istituto Oncologico della Svizzera Italiana | |
Lugano, Switzerland, CH-6900 | |
University Hospital | |
Basel, Switzerland, CH-4031 | |
Klinik Hirslanden | |
Zurich, Switzerland, CH-8008 | |
Office of Walter Weber-Stadelman | |
Basel, Switzerland, CH 4051 | |
Ospedale San Giovanni | |
Bellinzona, Switzerland, CH-6500 | |
Kantonspital Aarau | |
Aarau, Switzerland, 5001 |
Study Chair: | Michele Ghielmini, MD | Oncology Institute of Southern Switzerland |
Study ID Numbers: | CDR0000066188, SWS-SAKK-35/98, ICR-35/98, EU-98009 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003280 |
Health Authority: | United States: Federal Government |
stage I mantle cell lymphoma contiguous stage II mantle cell lymphoma noncontiguous stage II mantle cell lymphoma |
stage III mantle cell lymphoma stage IV mantle cell lymphoma recurrent mantle cell lymphoma |
Antibodies, Monoclonal Lymphatic Diseases Antibodies Immunoproliferative Disorders Rituximab Lymphoma, Mantle-Cell |
Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mantle cell lymphoma Lymphoma Recurrence Immunoglobulins |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Antirheumatic Agents Pharmacologic Actions |