Lenalidomide, Bendamustine and Rituximab as First-line Therapy for Patients Over 65 Years With Mantle Cell Lymphoma. (LENA-BERIT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00963534|
Recruitment Status : Completed
First Posted : August 21, 2009
Last Update Posted : March 12, 2018
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
|Condition or disease||Intervention/treatment||Phase|
|Mantle Cell Lymphoma||Drug: lenalidomide, bendamustine, rituximab||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lenalidomide, Bendamustine and Rituximab as First-line Therapy for Patients Over 65 Years With Mantle Cell Lymphoma - a Nordic Lymphoma Group Trial|
|Actual Study Start Date :||September 2009|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||August 2017|
U.S. FDA Resources
|Experimental: lenalidomide, bendamustine, rituximab||
Drug: lenalidomide, bendamustine, rituximab
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00963534
|Rigshospitalet, Department of Hematology|
|Århus University Hospital|
|Helsinki University Central Hospital|
|Haukeland University Hospital, Department of Oncology|
|Norwegian Radium Hospital|
|Ulleval University Hospital, Department of Oncology|
|University Hospital of Stavanger, Department of Haematology and Oncology|
|University Hospital of Tromso, Department of Oncology|
|Sahlgrenska University Hospital, Department of Hematology|
|Göteborg, Sweden, 413 45|
|University Hospital Linköping, Department of Hematology|
|Linköping, Sweden, 581 85|
|Sunderbyn Hospital, Department of Medicine|
|Luleå, Sweden, 971 80|
|University Hospital Lund, Department of Oncology|
|Lund, Sweden, 221 85|
|Karolinska University Hospital, Department of Hematology|
|Stockholm, Sweden, 171 76|
|Sundsvall Hospital, Department of Medicine|
|Sundsvall, Sweden, 851 86|
|University Hospital of Norrland, Department of Oncology|
|Umeå, Sweden, 981 85|
|Uppsala University Hospital, Department of Oncology|
|Uppsala, Sweden, 751 85|
|Principal Investigator:||Mats Jerkeman, MD, PhD||University Hospital Lund, Sweden|
|Study Director:||Jan Sundberg, RN||University Hospital Lund, Sweden|