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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: | NCT00535873 |
Purpose
Primary Objective:
Secondary Objective:
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia CLL Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma |
Drug: Lenalidomide |
Phase 2 |
| 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 Lenalidomide as Initial Treatment of Patients With Chronic Lymphocytic Leukemia Age 65 or Older - RV-CLL-PI-0188 |
| Estimated Enrollment: | 60 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Lenalidomide |
Drug: Lenalidomide
Starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
Other Names:
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 65 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: | Alessandra Ferrajoli, M.D. | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00535873 History of Changes |
| Other Study ID Numbers: | 2006-0715 |
| Study First Received: | September 25, 2007 |
| Last Updated: | December 14, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Leukemia CLL chronic lymphocytic leukemia SLL small lymphocytic lymphoma |
Untreated CLL Lenalidomide CC-5013 Revlimid Oral |
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphoma 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 |