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Sponsors and Collaborators: |
SuperGen Eisai Medical Research Inc. |
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Information provided by: | SuperGen |
ClinicalTrials.gov Identifier: | NCT00042003 |
To determine the safety and efficacy of decitabine in patients with Philadelphia chromosome-positive chronic myelogenous leukemia blastic phase that were previously treated with imatinib mesylate (STI 571) and became resistant/refractory or were found to be intolerant to the drug.
Condition | Intervention | Phase |
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Chronic Myelogenous Leukemia |
Drug: decitabine (5-aza-2'deoxycytidine) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Multicenter Study of Decitabine (5-Aza-2’Deoxycytidine) in Chronic Myelogenous Leukemia Blast Phase Refractory to Imatinib Mesylate (STI 571) |
Ages Eligible for Study: | 2 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
United States, California | |
USC/Norris Cancer Center | |
Los Angeles, California, United States | |
Scripps Clinic | |
Escondido, California, United States | |
City of Hope Medical Center | |
Duarte, California, United States | |
United States, Minnesota | |
Metro-Minnesota CCOP | |
St. Louis Park, Minnesota, United States | |
United States, New York | |
New York Medical College | |
Valhalla, New York, United States | |
United States, South Carolina | |
Liberty Hematology/Oncology | |
Columbia, South Carolina, United States | |
United States, Texas | |
University of Texas MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
Canada, Ontario | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada |
Study ID Numbers: | DAC-012, DACO-012 |
Study First Received: | July 19, 2002 |
Last Updated: | August 2, 2006 |
ClinicalTrials.gov Identifier: | NCT00042003 |
Health Authority: | United States: Food and Drug Administration |
Chronic myelogenous leukemia CML CML-BP Blast phase Decitabine 5-aza-2’deoxycytidine |
Methylation STI 571 Imatinib mesylate Gleevec BCR/ABL |
Imatinib Blast Crisis Leukemia Chronic myelogenous leukemia Hematologic Diseases Azacitidine |
Myeloproliferative Disorders Leukemia, Myelogenous, Chronic, BCR-ABL Positive Decitabine Leukemia, Myeloid Bone Marrow Diseases |
Antimetabolites Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Protein Kinase Inhibitors |
Pharmacologic Actions Neoplasms Neoplastic Processes Pathologic Processes Therapeutic Uses Cell Transformation, Neoplastic |