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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: | NCT00695786 |
Primary Objective:
1. To evaluate the overall response rate of lenalidomide in combination with rituximab in previously untreated indolent non-Hodgkin's lymphoma (NHL).
Secondary Study Objective:
1. To evaluate the toxicity of lenalidomide in combination with Rituximab in previously untreated indolent non-Hodgkin's lymphoma.
Primary Endpoint:
1. To determine the number of CR, and PR.
Secondary Endpoint:
1. Determine the type, frequency, severity, and relationship of adverse events to lenalidomide and rituximab.
Condition | Intervention | Phase |
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Lymphoma |
Drug: Lenalidomide Drug: Rituximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Lenalidomide (Revlimid) in Combination With Rituximab as Initial Treatment for Patients With Indolent Non-Hodgkin's Lymphoma (NHL) |
Estimated Enrollment: | 30 |
Study Start Date: | June 2008 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Lenalidomide + Rituximab
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Drug: Lenalidomide
20 mg PO Daily x 21 Days
Drug: Rituximab
375 mg/m^2 IV Over 4-8 Hours
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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: Felipe Samaniego, MD | 713-792-2860 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Felipe Samaniego, MD |
Principal Investigator: | Felipe Samaniego, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Felipe Samaniego, MD/Associate Professor ) |
Study ID Numbers: | 2008-0042 |
Study First Received: | June 10, 2008 |
Last Updated: | December 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00695786 |
Health Authority: | United States: Institutional Review Board |
Non-Hodgkin's Lymphoma Lymphoma Lenalidomide |
Revlimid Rituximab Rituxan |
Lymphatic Diseases Immunoproliferative Disorders Rituximab Lenalidomide |
Lymphoma, small cleaved-cell, diffuse Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Antirheumatic Agents Pharmacologic Actions |