Monoclonal Antibody Therapy in Treating Patients With Follicular or Mantle Cell Lymphoma
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.
|Study Design:||Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
|Study Start Date:||January 1998|
|Study Completion Date:||March 2002|
|Primary Completion Date:||March 2002 (Final data collection date for primary outcome measure)|
- Assess the clinical efficacy of consolidation treatment with rituximab in terms of response rate in patients with follicular (closed to accrual 9/18/00) or mantle cell lymphoma.
- Compare the event free survival of patients after induction with or without consolidation.
- Compare the tolerability of these two treatment regimens by these patients.
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.
- Arm I: Patients are observed.
- Arm II: Patients receive rituximab IV over 3-5 hours once a week during weeks 12, 20, 28, and 36.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003280
|Aarau, Switzerland, 5001|
|Office of Walter Weber-Stadelman|
|Basel, Switzerland, CH 4051|
|Basel, Switzerland, CH-4031|
|Ospedale San Giovanni|
|Bellinzona, Switzerland, CH-6500|
|Bern, Switzerland, CH-3010|
|Hopital Cantonal Universitaire de Geneva|
|Geneva, Switzerland, CH-1211|
|Istituto Oncologico della Svizzera Italiana|
|Lugano, Switzerland, CH-6900|
|Solothurn, Switzerland, 4500|
|City Hospital Triemli|
|Zurich, Switzerland, 8063|
|Zurich, Switzerland, CH-8008|
|Study Chair:||Michele Ghielmini, MD||Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni|