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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: | NCT00535873 |
The goal of this clinical research study is to find out if Revlimid™ (lenalidomide) can help to control CLL in patients 65 years of age or older.The safety of this drug will also be studied.
Optional Procedures: You will be asked to have additional blood drawn to look at biomarkers (levels of substances produced by the body when cancer is present) that can be affected by treatment with lenalidomide. The ability of lenalidomide to block the growth of the leukemia cells and to affect the cells in your immune system will also be checked.
You will also be asked to answer questionnaires about symptoms you may be experiencing.
Condition | Intervention | Phase |
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Leukemia CLL Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma |
Drug: Lenalidomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
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: | April 2011 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Lenalidomide
lenalidomide orally, daily at 5mg daily for 56 days followed by individual titration up of 5mg increments every 28 days to reach a maximum dose of 25mg daily based on patient tolerance.
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Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Alessandra Ferrajoli, M.D. | 713-792-2063 |
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 | |
Principal Investigator: Alessandra Ferrajoli, M.D. |
Principal Investigator: | Alessandra Ferrajoli, M.D. | M.D. Anderson Cancer Center |
Responsible Party: | The University of Texas M. D. Anderson Cancer Center ( Alessandra Ferrajoli M.D./ Assistant Professor ) |
Study ID Numbers: | 2006-0715 |
Study First Received: | September 25, 2007 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00535873 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Lenalidomide Leukemia CLL |
chronic lymphocytic leukemia SLL small lymphocytic lymphoma |
Lymphatic Diseases Leukemia Chronic Lymphocytic Leukemia Leukemia, Lymphoid Immunoproliferative Disorders Leukemia, Lymphocytic, Chronic, B-Cell |
Lenalidomide Leukemia, B-cell, Chronic Lymphoproliferative Disorders Leukemia, B-Cell Lymphoma |
Leukemia, Lymphoid Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Antineoplastic Agents Lenalidomide Pharmacologic Actions Leukemia |
Lymphatic Diseases Neoplasms Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Leukemia, B-Cell Lymphoproliferative Disorders Lymphoma |