Status:
COMPLETED
Lenalidomide, Bendamustine and Rituximab as First-line Therapy for Patients Over 65 Years With Mantle Cell Lymphoma.
Lead Sponsor:
Lund University Hospital
Collaborating Sponsors:
Mundipharma Pte Ltd.
Celgene
Conditions:
Mantle Cell Lymphoma
Eligibility:
All Genders
65+ years
Phase:
PHASE1
PHASE2
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...
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 thi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00963534
Start Date
September 1 2009
End Date
August 1 2017
Last Update
March 12 2018
Active Locations (17)
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1
Århus University Hospital
Aarhus, Denmark
2
Herlev Hospital
Copenhagen, Denmark
3
Rigshospitalet, Department of Hematology
Copenhagen, Denmark
4
Helsinki University Central Hospital
Helsinki, Finland