Lenalidomide, Bendamustine and Rituximab as First-line Therapy for Patients Over 65 Years With Mantle Cell Lymphoma - a Nordic Lymphoma Group Trial
This trial consists of both a phase I portion and a phase II portion. In phase I, the MTD of
lenalidomide is determined, starting with 5 mg/day given up to maximally 25 mg/day. In
combination with this treatment, bendamustine and rituximab are given at fixed doses.
The phase I portion follows a sequential dose escalation, 3+3 design. Initially, three
subjects are started treatment with dose regimen 1 (5 mg/day). After the third subject
completed two cycles of treatment, if no DLT has occured, the next group of three subjects
are treated at the next dose level of lenalidomide (10 mg/day). If one of the three initial
subjects experiences a DLT, the cohort is expanded to six subjects. If less than two out of
the six subjects experiences a DLT, then the next higher dose group is initiated. If two or
more subjects experiences a DLT, no higher dose levels will be tested and the MTD dose has
Additional subjects are enrolled at the MTD on the phase II portion of the trial.
The above described treatment with lenalidomide, bendamustine and rituximab are given in 6
cycles, cycle length 22 days. Lenalidomide is given day 1-21, bendamustine day 1-2 and
rituximab day 1. During the following maintenance treatment, single treatment with
lenalidomide will be given with the same dose of lenalidomide (25 mg/day) for 7 cycles,
whether in phase I or phase II portion of the trial.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD of lenalidomide (phase I) Progression free survival (phase II)
Mats Jerkeman, MD, PhD
University Hospital Lund, Sweden
Sweden: Medical Products Agency