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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Celgene Corporation |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00294632 |
Primary Objectives:
Condition | Intervention | Phase |
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Lymphoma |
Drug: Lenalidomide Drug: Rituximab |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
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 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Lenalidomide + Rituximab
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Drug: Lenalidomide
10 mg PO Daily on Days 1-21
Drug: Rituximab
375 mg/m^2 IV Weekly x 4 Weeks
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michael Wang, MD | 713-792-2860 | |
Contact: Ginger Beasley, RN | 713-792-3610 |
United States, Texas | |
UT MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Michael Wang, MD 713-792-2860 | |
Contact: Ginger Beasley, RN 713-792-3610 | |
Principal Investigator: Michael Wang, MD |
Principal Investigator: | Michael Wang, MD | UT MD Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Michael Wang, MD/Assistant Professor ) |
Study ID Numbers: | 2005-0461 |
Study First Received: | February 20, 2006 |
Last Updated: | November 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00294632 |
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, Large B-Cell, Diffuse Immunoproliferative Disorders Rituximab Lymphoma, Mantle-Cell Lenalidomide Lymphoma, Follicular Lymphoma, small cleaved-cell, diffuse Mantle cell lymphoma |
Lymphoma, large-cell Lymphoma, B-Cell Lymphatic Diseases B-cell lymphomas Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Follicular lymphoma |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Antirheumatic Agents Pharmacologic Actions |