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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00632359 |
Purpose
The goal of this clinical research study is to learn if RevlimidTM (lenalidomide) can help to reduce the level of leukemia in your body. The safety of this drug will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Lymphocytic Leukemia |
Drug: Lenalidomide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Study of Lenalidomide in Patients With Chronic Lymphocytic Leukemia and Residual Disease After Chemotherapy - RV-CLL-PI-0270 |
| Estimated Enrollment: | 52 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Lenalidomide |
Drug: Lenalidomide
10 mg daily given for 12 months
Other Name: Revlimid
|
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: Alessandra Ferrajoli, M.D. | 713-792-2063 | aferrajo@mdanderson.org |
| United States, Texas | |
| The University of Texas M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Alessandra Ferrajoli, M.D. 713-792-2063 aferrajo@mdanderson.org | |
| Principal Investigator: | Alessandra Ferrajoli, M.D, | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00632359 History of Changes |
| Other Study ID Numbers: | 2007-0213 |
| Study First Received: | March 3, 2008 |
| Last Updated: | May 11, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Chronic Lymphocytic Leukemia CLL Lenalidomide Revlimid |
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lenalidomide Thalidomide Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |