NCT00075946

Rituximab in Treating Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma

Randomized Phase III Trial Comparing Two Different Rituximab Dosing Regimens For Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 545 (actual)
• Sponsor: Eastern Cooperative Oncology Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: Primary * To compare time to rituximab failure between the rituximab scheduled and rituximab retreatment arms. Secondary * To compare the time to first cytotoxic therapy between the rituximab scheduled and rituximab retreatment arms. * To document the rationale for beginning cytotoxic therapy; defined as chemotherapy, radiation therapy or radioimmunotherapy. * To compare the toxicities associated with rituximab therapy between the two randomized treatment arms. * Quality of Life Objectives: 1. To compare health-related quality of life, distress, psychological functioning, physical well-being and functional well-being of patients receiving rituximab scheduled to those receiving rituximab retreatment. 2. To examine the impact of differential treatment response (delayed time to rituximab failure and/or time to first cytotoxic therapy), if observed, on quality of life, distress, and psychological functioning on patients receiving rituximab scheduled to those receiving rituximab retreatment. 3. To obtain prospective data on physical and functional well-being during treatment with rituximab. 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 Intravenous (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 A (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 B (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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	rituximab	Given IV

Timeline

• Start date: 2004-01-23
• Primary completion: 2013-09-01
• Completion: 2021-08-01
• First posted: 2004-01-14
• Last updated: 2024-02-01
• Results posted: 2015-06-22

Locations

483 sites across 1 country: United States