A Phase 1/2 interventional study of lenalidomide, bendamustine, rituximab and lenalidomide, bendamustine, rituximab in Mantle Cell Lymphoma, sponsored by Lund University Hospital. Completed at 17 sites in 4 countries. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2018-03-12.
Sponsored by Lund University Hospital · Phase 1/2, Interventional, and Treatment
In phase I: Establishing maximally tolerated dose of lenalidomide in combination with bendamustine and rituximab.
In phase II: Evaluation of progression free survival with treatment with lenalidomide, bendamustine and rituximab
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 been exceeded.
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 51 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
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Drug: lenalidomide, bendamustine, rituximab
Phase I: Maximally tolerable dose of lenalidomide will be determined, starting with 5 mg per day, and up to maximally 25 mg per day. This treatment is given in combination with bendamustine and rituximab. Phase II: Determination of progression free survival with treatment with lenalidomide (dosing determined in phase I) in combination with bendamustine and rituximab.
lenalidomide: day 1-21, maximum 13 cycles bendamustine: days 1-2, cycle 1-6 rituximab: day1, cycle 1-6
MTD of lenalidomide (phase I) Progression free survival (phase II)
Time frame: 2 years
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Lund University Hospital