ReBeL study: A randomized phase I/II trial of lenalidomide and rituximab with or without bendamustine in patients ≥ 18 years with relapsed follicular lymphoma. A HOVON/GLSG study.
Completed
- Conditions
- Relapsed CD20+ follicular lymphoma
- Registration Number
- NL-OMON22769
- Lead Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) P/a HOVON Data CenterErasmus MC - Daniel den HoedP.O. box 52013008 AE RotterdamTel: +31 10 7041560Fax: +31 10 7041028e-mail: hdc@erasmusmc.nl
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 174
Inclusion Criteria
1. Relapsed FL grade 1, 2, 3a;
2. Ann Arbor stage II-IV at relapse;
Exclusion Criteria
1. Rituximab-refractory patients (definition: progression during or within 6 months after rituximab containing immunochemotherapy or rituximab maintenance treatment);
2. Clinical or histologic signs of transformation;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method For the phase I part of the study: To determine the dose limiting toxicity (DLT) and recommended dose level (RDL) of lenalidomide and bendamustine given in combination with rituximab for the phase II part of the study.<br /><br>For the phase II of the study: To determine the efficacy and toxicity of the two arms of the study (arm A: lenalidomide and rituximab, and arm B: lenalidomide, rituximab and bendamustine) in patients with relapsed follicular lymphoma (FL) and to identify the most promising of these two treatment arms.
- Secondary Outcome Measures
Name Time Method