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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Bristol-Myers Squibb |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00254423 |
The goal of this clinical research study is to learn if BMS-354825 (dasatinib) can help to control CML in chronic phase. The safety of this drug will also be studied.
Optional Procedures: You will be asked to have extra blood and/or bone marrow samples taken. These samples will be used to study the effect of the treatment on leukemia cells.
Condition | Intervention | Phase |
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Chronic Myelogenous Leukemia |
Drug: Dasatinib (BMS-354825) Drug: Dasatinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With Dasatinib (BMS-354825) |
Estimated Enrollment: | 100 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Dasatinib
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Drug: Dasatinib (BMS-354825)
Dasatinib 100 mg orally, daily
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2: Experimental
Dasatinib
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Drug: Dasatinib
Dasatinib 50 mg orally twice daily
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Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jorge Cortes, MD | 713-794-5783 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Jorge Cortes, MD |
Principal Investigator: | Jorge Cortes, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | The University of Texas M. D. Anderson Cancer Center ( Jorge Cortes M.D./Professor ) |
Study ID Numbers: | 2005-0422 |
Study First Received: | November 14, 2005 |
Last Updated: | August 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00254423 |
Health Authority: | United States: Food and Drug Administration |
Chronic Myelogenous Leukemia Dasatinib BMS-354825 |
Leukemia Chronic myelogenous leukemia Hematologic Diseases Dasatinib Myeloproliferative Disorders |
Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Chronic-Phase Leukemia, Myeloid Bone Marrow Diseases |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action |
Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |