NCT00093769

Bortezomib and Rituximab in Treating Patients With Non-Hodgkin's Lymphoma

A Phase II Study of VELCADE With Rituximab in Subjects With Relapsed or Refractory Indolent B-Cell Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Giving bortezomib together with rituximab may kill more cancer cells. PURPOSE: This randomized phase II trial is studying how well giving bortezomib together with rituximab works in treating patients with relapsed or refractory non-Hodgkin's lymphoma.

Detailed description

OBJECTIVES: Primary * Determine the response rate (complete response \[CR\], CR-unconfirmed \[CRu\], and partial response \[PR\]) in patients with relapsed or refractory indolent B-cell non-Hodgkin's lymphoma treated with bortezomib and rituximab. Secondary * Determine the response rate (CR, CRu, and PR) at the first disease response evaluation in patients treated with this regimen. * Determine the overall CR rate (CR and CRu) in patients treated with this regimen. * Determine the time to progression in patients treated with this regimen. * Determine the duration of response in patients treated with this regimen. * Determine the time to best response in patients treated with this regimen. * Determine the safety and tolerability of this regimen in these patients. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center, Karnofsky performance status (\< 70% vs ≥ 70%), lactic dehydrogenase level (normal vs \> upper limit of normal), age (18 to 60 years vs \> 60 years), and lymphoma subtype (follicular vs marginal zone). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Patients also receive rituximab IV on days 1, 8, and 15 of course 1 only and on day 1 of course 2 only. Treatment with repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive bortezomib IV over 3-5 seconds on days 1, 8, 15 and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 only. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients in either arm may crossover to the other arm if treatment is found to be ineffective. Patients are followed at 30 days and then every 12 weeks thereafter. PROJECTED ACCRUAL: A total of 24-66 patients (12-33 per treatment arm) will be accrued for this study within 1 year.

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	bortezomib + rituximab	Arm I: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Patients also receive rituximab IV on days 1, 8, and 15 of course 1 only and on day 1 of course 2 only. Treatment with repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive bortezomib IV over 3-5 seconds on days 1, 8, 15 and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 only. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients in either arm may crossover to the other arm if treatment is found to be ineffective.

Timeline

• Start date: 2004-08-01
• Primary completion: 2005-08-01
• First posted: 2004-10-08
• Last updated: 2012-10-04

Locations

1 site across 1 country: United States