Rituximab, Bendamustine Hydrochloride, and Lenalidomide in Treating Patients With Aggressive B-Cell Lymphoma
- Conditions
- Lymphoma
- Interventions
- Registration Number
- NCT00987493
- Lead Sponsor
- Swiss Group for Clinical Cancer Research
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment with rituximab, bendamustine and lenalidomide rituximab - Treatment with rituximab, bendamustine and lenalidomide bendamustine hydrochloride - Treatment with rituximab, bendamustine and lenalidomide lenalidomide -
- Primary Outcome Measures
Name Time Method Maximum-tolerated dose (phase I) at the end of phase I (31 August 2011) Dose-limiting toxicity (phase I) at 4 weeks. Objective response (complete and partial response) (phase II) phase II (3 years)
- Secondary Outcome Measures
Name Time Method Association between WHO performance status, QOL indicators, and SAKK C-SGA scores End of phase II (excluding follow-up) at 3 years. Event-free survival (phase II) up to 30 months for each patient. Time to progression (phase II) up to 30 months for each patient. Defined as the time from registration until documented lymphoma progression or death as a result of lymphoma. Patients not experiencing an event will be censored at the last time they were known to be in remission
Usefulness and feasibility of the SAKK C-SGA End of phase II (excluding follow-up) at 3 years. Overall survival (phase II) up to 30 months for each patient. Progression Free Survival (PFS) up to 30 months for each patient. Time from registration until one of the following events (whichever occurs first):
* Relapse or progression assessed according to the International Workshop NHL criteria (1999)
* Death of any causeAdverse events according to NCI CTCAE v. 3.0 All AEs will be assessed according to NCI CTCAE v3.0 until 30 days after trial therapy end. Response duration (phase II) up to 30 months for each patient. From the time when criteria for response (CR/CRu or PR) are met, until documentation of relapse or progression thereafter. Only patients with a response (CR/ CRu or PR) shall be included in this analysis. Patients with no disease progression or relapse shall be censored at the last time they were known to be in remission
Quality of life approx. 5 months for each patient.
Trial Locations
- Locations (16)
Inselspital Bern
🇨ðŸ‡Bern, Switzerland
Stadtspital Triemli
🇨ðŸ‡Zürich, Switzerland
Kantonsspital Baden
🇨ðŸ‡Baden, Switzerland
Kantonsspital Graubünden
🇨ðŸ‡Chur, Switzerland
Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli
🇨ðŸ‡Bellinzona, Switzerland
Kantonsspital Bruderholz
🇨ðŸ‡Bruderholz, Switzerland
Hôpitaux Universitaires de Genève HUG
🇨ðŸ‡Geneva 14, Switzerland
Universitaetsspital Basel
🇨ðŸ‡Basel, Switzerland
Centre Hospitalier Universitaire Vaudois
🇨ðŸ‡Lausanne, Switzerland
Hopital Fribourgeois
🇨ðŸ‡Fribourg, Switzerland
Kantonsspital Liestal
🇨ðŸ‡Liestal, Switzerland
Kantonsspital Olten
🇨ðŸ‡Olten, Switzerland
Kantonsspital St. Gallen
🇨ðŸ‡St. Gallen, Switzerland
St. Claraspital AG
🇨ðŸ‡Basel, Switzerland
Universitäts Spital Zürich
🇨ðŸ‡Zürich, Switzerland
Kantonsspital Winterthur
🇨ðŸ‡Winterthur, Switzerland