NCT00987493

Rituximab, Bendamustine Hydrochloride, and Lenalidomide in Treating Patients With Aggressive B-Cell Lymphoma

Rituximab, Bendamustine and Lenalidomide in Patients With Aggressive B-cell Lymphoma Not Eligible for High Dose Chemotherapy or Anthracycline-Based Therapy. A Phase I/II Trial.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Swiss Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer cell growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cell-killing substances to them. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Lenalidomide may stop the growth of cancer by blocking blood flow to the tumor. Giving rituximab together with bendamustine hydrochloride and lenalidomide may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of giving rituximab together with bendamustine hydrochloride and lenalidomide in treating patients with aggressive B-cell lymphoma.

Detailed description

OBJECTIVES: Primary * To determine the maximum-tolerated dose of the combination of rituximab, bendamustine hydrochloride, and lenalidomide in patients with aggressive B-cell lymphoma not eligible for anthracycline-based first-line treatment or intensive regimens including high-dose therapy (HDT) followed by autologous stem cell transplantation (ASCT) in refractory or relapsing disease, or as treatment for patients relapsing after HDT with ASCT. (phase I). * To identify the recommended dose of this regimen for a phase II study (phase I). * To determine the efficacy and safety of this regimen in these patients (phase II). Secondary * To assess the quality of life (QOL) of patients treated with this regimen (phase II). * To evaluate the usefulness and feasibility of the SAKK Cancer-Specific Geriatric Assessment (C-SGA) in patients treated with this regimen (phase II). * To assess the association between WHO performance status, QOL indicators, and SAKK C-SGA scores (phase II). * To describe changes in SAKK C-SGA scores from pre- to post-treatment and in QOL (phase II). OUTLINE: This is a multicenter, phase I dose-escalation study of bendamustine hydrochloride and lenalidomide followed by a phase II study. Patients receive rituximab IV on day 1, bendamustine hydrochloride IV over 30-60 minutes on days 1-2, and oral lenalidomide on days 1-21. Courses repeat every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients on phase II study complete the SAKK Cancer-Specific Geriatric Assessment at baseline and after completion of course 1. Patients also complete quality-of-life questionnaires at baseline and periodically during study. After completion of study therapy, patients are followed for up to 2 years.

Conditions

• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	rituximab	day 1 at a fixed dose of 375mg/m2
DRUG	bendamustine hydrochloride	Bendamustine at day 1 and 2 according to the dose escalation in phase I, and at the recommended dose in phase II: 70mg/m2.
DRUG	lenalidomide	Lenalidomide at days 1-21 according to the dose escalation in phase I, and at the recommended dose in phase II: 10mg

Timeline

• Start date: 2009-09-01
• Primary completion: 2014-04-01
• Completion: 2016-04-01
• First posted: 2009-10-01
• Last updated: 2019-05-15

Locations

16 sites across 1 country: Switzerland