Lenalidomide and Rituximab in the Treatment of Relapsed Mantle Cell Lymphoma (MCL) and Diffuse Large B-Cell Lymphoma

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00294632
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Lenalidomide — DRUG
    Starting Dose 10 mg By Mouth Daily on Days 1-21
  • Rituximab — DRUG
    375 mg/m\^2 By Vein Weekly for 4 Weeks

Study Details

The goal of this clinical research study is to find the highest tolerable dose of the drug lenalidomide (Revlimid, lenalidomide) that can be given with Rituxan® (rituximab) in the treatment of relapsed mantle cell lymphoma. The safety and effectiveness of this combination treatment will also be studied in both mantle cell lymphoma and diffuse large B-cell non-Hodgkin's lymphoma, transformed large cell lymphoma, and/or Grade 3 follicular lymphoma (follicular cleaved large cell lymphoma or follicular non-cleaved large cell lymphoma).

Key Dates

Start date
Feb 28, 2006
Status verified
Feb 2020
Primary completion
Feb 29, 2016
Completion
Feb 29, 2016

Study Design

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

Arms

  • Experimental: Lenalidomide + Rituximab
    Lenalidomide Starting Dose 10 mg oral daily on Days 1-21 + Rituximab 375 mg/m\^2 intravenous weekly for 4 weeks

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Lenalidomide in Combination With Rituximab [ Time Frame: 28 days of cycle 1 ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

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