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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Celgene Corporation |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00294632 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: Lenalidomide Drug: Rituximab |
Phase I Phase II |
| Study Type: | Interventional |
| 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) |
| Estimated Enrollment: | 112 |
| Study Start Date: | February 2006 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Lenalidomide + Rituximab
Lenalidomide Starting Dose 10 mg oral daily on Days 1-21 + Rituximab 375 mg/m^2 intravenous weekly for 4 weeks
|
Drug: Lenalidomide
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Michael Wang, MD | UT MD Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00294632 History of Changes |
| Other Study ID Numbers: | 2005-0461 |
| Study First Received: | February 20, 2006 |
| Last Updated: | December 22, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Mantle Cell Lymphoma B-Cell Non-Hodgkin's Lymphoma Transformed Large Cell Lymphoma Follicular Lymphoma Lymphoma MCL |
Lenalidomide CC-5013 Revlimid™ Rituximab Rituxan |
|
Lymphoma Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoma, B-Cell Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Rituximab Thalidomide Lenalidomide |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents Immunosuppressive Agents Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |