Lenalidomide and Rituximab in the Treatment of Relapsed Mantle Cell Lymphoma (MCL) and Diffuse Large B-Cell Lymphoma
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).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Lenalidomide and Rituximab Treatment of Relapsed 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 (RV-LYM-PI-0056)|
- Maximum Tolerated Dose (MTD) of Lenalidomide in Combination with Rituximab i [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]MTD is defined as the highest dose level in which 1 or fewer pts experienced a dose limiting toxicity (DLT) in 6 pts treated. DLT is any grade III or IV toxicity during the first 28 days (first cycle) of therapy.
- Objective Response Rate [ Time Frame: 56 days ] [ Designated as safety issue: No ]Objective response rate defined as complete or partial response after 2 cycles of therapy maintained for one month. Objective response monitored using Simon's optimal 2-stage design.
|Study Start Date:||February 2006|
|Estimated Primary Completion Date:||February 2017 (Final data collection date for primary outcome measure)|
Experimental: Lenalidomide + Rituximab
Lenalidomide Starting Dose 10 mg oral daily on Days 1-21 + Rituximab 375 mg/m^2 intravenous weekly for 4 weeks
Starting Dose 10 mg By Mouth Daily on Days 1-21
Other Names:Drug: Rituximab
375 mg/m^2 By Vein Weekly for 4 Weeks
Other Name: Rituxan
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00294632
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Michael Wang, MD||M.D. Anderson Cancer Center|