Rituximab in Treating Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma
Recruitment status was Active, not recruiting
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 rituximab regimen is more effective in treating indolent non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying two different schedules of rituximab and comparing them to see how well they work in treating patients with low tumor burden indolent stage III non-Hodgkin's lymphoma or stage IV non-Hodgkin's lymphoma.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Randomized Phase III Trial Comparing Two Different Rituximab Dosing Regimens For Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma|
- Time to treatment failure [ Designated as safety issue: No ]
- Time to first cytotoxic therapy [ Designated as safety issue: No ]
|Study Start Date:||November 2003|
|Estimated Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Arm I
Patients receive rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months.
Experimental: Arm II
Patients receive a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity.
- Compare the time to rituximab failure in patients with low tumor burden indolent non-Hodgkin's lymphoma treated with rituximab scheduled vs rituximab retreatment.
- Compare the time to first cytotoxic therapy in patients treated with these regimens.
- Determine the rationale for beginning cytotoxic therapy, defined as chemotherapy, radiotherapy, or radioimmunotherapy, in patients treated with these regimens.
- Compare the toxic effects associated with these regimens in these patients.
- Correlate response and duration of response in these patients with rituximab pharmacokinetics.
- Compare the health-related quality of life, distress, psychological functioning, physical well-being, and functional well-being of patients treated with these regimens.
- Compare the impact of differential treatment response (delayed time to rituximab failure and/or time to first cytotoxic therapy) on quality of life, distress, and psychological functioning in patients treated with these regimens.
- Determine, prospectively, the physical and functional well-being of patients during treatment with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to histologic subtype (follicular vs other), age (under 60 vs 60 and over), and the time from diagnosis (less than 1 year vs at least 1 year).
- Induction rituximab: Patients receive rituximab IV once a week for 4 weeks. Patients are re-evaluated 9 weeks after the completion of induction rituximab. Patients with a partial or complete response to induction rituximab are randomized to 1 of 2 treatment arms.
- Arm I (retreatment rituximab): Patients receive rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months.
- Arm II (scheduled rituximab): Patients receive a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity.
Quality of life is assessed after induction rituximab treatment and at 26, 39, 65, 117, 169, and 221 weeks after randomization.
Patients are followed at least annually for 15 years from study entry.
PROJECTED ACCRUAL: A total of 389 patients will be accrued for this study within 45 months.