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Brief Title: Lenalidomide, Bendamustine and Rituximab as First-line Therapy for Patients Over 65 Years With Mantle Cell Lymphoma.
Official Title: Lenalidomide, Bendamustine and Rituximab as First-line Therapy for Patients Over 65 Years With Mantle Cell Lymphoma - a Nordic Lymphoma Group Trial
Study ID: NCT00963534
Brief Summary: 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
Detailed Description: 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.
Minimum Age: 65 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Herlev Hospital, Copenhagen, , Denmark
Rigshospitalet, Department of Hematology, Copenhagen, , Denmark
Århus University Hospital, Århus, , Denmark
Helsinki University Central Hospital, Helsinki, , Finland
Haukeland University Hospital, Department of Oncology, Bergen, , Norway
Norwegian Radium Hospital, Oslo, , Norway
Ulleval University Hospital, Department of Oncology, Oslo, , Norway
University Hospital of Stavanger, Department of Haematology and Oncology, Stavanger, , Norway
University Hospital of Tromso, Department of Oncology, Tromso, , Norway
Sahlgrenska University Hospital, Department of Hematology, Göteborg, , Sweden
University Hospital Linköping, Department of Hematology, Linköping, , Sweden
Sunderbyn Hospital, Department of Medicine, Luleå, , Sweden
University Hospital Lund, Department of Oncology, Lund, , Sweden
Karolinska University Hospital, Department of Hematology, Stockholm, , Sweden
Sundsvall Hospital, Department of Medicine, Sundsvall, , Sweden
University Hospital of Norrland, Department of Oncology, Umeå, , Sweden
Uppsala University Hospital, Department of Oncology, Uppsala, , Sweden
Name: Mats Jerkeman, MD, PhD
Affiliation: University Hospital Lund, Sweden
Role: PRINCIPAL_INVESTIGATOR
Name: Jan Sundberg, RN
Affiliation: University Hospital Lund, Sweden
Role: STUDY_DIRECTOR