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

Sponsor
Lund University Hospital
Study ID
NCT00963534
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • lenalidomide, bendamustine, rituximab — DRUG
    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, bendamustine, rituximab — DRUG
    lenalidomide: day 1-21, maximum 13 cycles bendamustine: days 1-2, cycle 1-6 rituximab: day1, cycle 1-6

Study Details

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

Key Dates

Start date
Sep 30, 2009
Status verified
Mar 2018
Primary completion
Aug 31, 2017
Completion
Aug 31, 2017

Study Design

Enrollment
51 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: lenalidomide, bendamustine, rituximab

Primary Outcome Measure

MTD of lenalidomide (phase I) Progression free survival (phase II) [ Time Frame: 2 years ]

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