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
OBJECTIVES:
- 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.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Michele Ghielmini, MD
Study Chair
Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
Switzerland: Swissmedic
SAKK 35/98
NCT00003280
January 1998
March 2002
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