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

• Status: Completed
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lund University Hospital
• Collaborators: Celgene; Mundipharma Pte Ltd.; Roche Pharma AG
• Treatments: Bendamustine Hydrochloride; Lenalidomide; Rituximab; Thalidomide

Criteria

Inclusion Criteria:

• Age over 65 years, or age under 65 years, unable to tolerate high dose chemotherapy with autologous stem cell support

• Histologically confirmed mantle cell lymphoma, stage II-IV at time of diagnosis

• No previous treatment for lymphoma except radiotherapy or one cycle of any chemotherapy regimen for lymphoma

• WHO Performance Status 0-3

• Written informed concent

• Female subjects of childbearing potential must agree to use and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, through study drug therapy and for 4 weeks after the end of study drug therapy

• Male subjects must agree to use condoms throughout study drug therapy if their partner is of childbearing potential, and has no contraception, and agree to not donate semen during study drug therapy and for one week after end of study drug therapy

• All subjects must agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation, and agree not to share study medication with another person

Exclusion Criteria:

• Impaired liver function

• ANC less than 1.0 x 10 9, unless caused by bone marrow infiltration by lymphoma

• Platelet count less than 60 x 10 9, unless caused by bone marrow infiltration by lymphoma

• Creatinine clearance below 50 ml/min (cockcroft formula))

• Known HIV positivity

• Known seropositivity for HCV, HBsAG, anti-HBc, or other active infection uncontrolled by treatment

• Psychiatric illness or condition which could interfere with the subject´s ability to understand the requirements of the study

• Requirement of corticosteroid therapy at a dose over 10 mg prednisolone/day

• Pregnant or lactating females