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Spots Global Cancer Trial Database for Lenalidomide, Bendamustine and Rituximab as First-line Therapy for Patients Over 65 Years With Mantle Cell Lymphoma.

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 65 Years

Eligible Ages: OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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