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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: | NCT00695786 |
Purpose
The goal of this clinical research study is to learn if lenalidomide in combination with rituximab in previously untreated indolent non-Hodgkin's lymphoma can control the disease. The safety of this combination will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: Lenalidomide Drug: Rituximab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Revlimid in Combination With Rituximab as Initial Treatment for Patients With Indolent Non-Hodgkin's Lymphoma (NHL) |
| Estimated Enrollment: | 155 |
| Study Start Date: | June 2008 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Lenalidomide + Rituximab |
Drug: Lenalidomide
20 mg by mouth (PO) daily on days 1 - 21 followed by 7 days rest (28 day cycle). Following cycle 3, if patients fail to show a response (partial or complete) the dose will be increased to 25mg/day. Schedule B: Lenalidomide will be administered orally at 20 mg total daily dose on days 2 to 22 of a 28 day cycle in patients with follicular lymphoma. Following cycle 3, if patients fail to show a response (partial or complete) the dose will be increased to 25mg/day. Patients with a diagnosis of small lymphocytic lymphoma (SLL) will begin at a dose of 10 mg total daily on days 2 to 22 of a 28 day cycle. This dose will be escalated by 5mg every 28 days up to 20mg if no toxicity is encountered. If no response is observed by cycle 3, the dose will be increased to 25 mg. Other Names:
Drug: Rituximab
375 mg/m^2 by vein over 4-8 Hours on day 1 of cycles 1-12 in schedule A, and day 1, 8,15, and 22 of cycle 1 and on day 1 of every subsequent cycle in schedule B.
Other Name: Rituxan
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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| Contact: Felipe Samaniego, MD | 713-792-2860 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Felipe Samaniego, MD | |
| Principal Investigator: | Felipe Samaniego, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00695786 History of Changes |
| Other Study ID Numbers: | 2008-0042 |
| Study First Received: | June 10, 2008 |
| Last Updated: | December 29, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Non-Hodgkin's Lymphoma Lymphoma Lenalidomide |
Revlimid Rituximab Rituxan |
|
Lymphoma Lymphoma, Non-Hodgkin 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 |