ReBeL Phase II (A HOVON 110FL/GLSG/NCRI study)
Research type
Research Study
Full title
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/NCRI study.
IRAS ID
115570
Contact name
Kim Linton
Contact email
Sponsor organisation
HOVON Foundation
Eudract number
2011-000097-56
Clinicaltrials.gov Identifier
TRIAL DUTCH REGISTRY, NTR3028
Duration of Study in the UK
10 years, 4 months, 1 days
Research summary
Follicular lymphoma (FL) is the second most frequent type of non-Hodgkin's lymphoma (NHL) and accounts for 20-25% of all lymphomas. Currently, there is no curative standard treatment for FL. Both lenalidomide and bendamustine show promising activity in FL, and because of limited toxicity, are good candidate drugs to use in combination therapy.
The combination of lenalidomide with rituximab seems especially advantageous as it can provide an effective chemotherapy-free regimen for (elderly or frail) NHL patients. On the other hand, combination with chemotherapeutic bendamustine might provide a more effective regimen.
The sponsor (HOVON) has completed a phase I run-in to establish the dose limiting toxicity and recommended dose level RDL for the combination of lenalidomide, rituximab, and bendamustine. In the UK we will take part in the randomised phase II part of the study to identify the most promising of these two experimental regimens to use in a subsequent randomised phase III study.
This is a phase II randomised, multicentre and prospective two arm trial (arm A (LR: lenalidomide and rituximab); arm B (LRB: lenalidomide, rituximab and bendamustine); recruiting 150 patients aged ≥ 18 years old, with relapsed FL. Patients will receive 3 cycles of treatment and then be reassessed. Those with evidence of progression will stop trial treatment. All other patients will continue with a further 3 cycles (to a total of 6), unless there is a clear clinical contraindication to further treatment followed by 2 years of maintenance treatment with Rituximab. Rituximab will be administered once every three months. Patients will then be followed for 5 years.
REC name
North West - Haydock Research Ethics Committee
REC reference
15/NW/0376
Date of REC Opinion
26 Jun 2015
REC opinion
Further Information Favourable Opinion