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| Sponsor: | Bristol-Myers Squibb |
|---|---|
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00101595 |
Purpose
The purpose of this clinical research study is to learn if BMS-354825 will have activity as defined by hematologic responses in subjects with lymphoid blast phase chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia with primary or acquired resistance to imatinib mesylate.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myeloid Leukemia Leukemia, Lymphoblastic, Acute, Philadelphia-Positive |
Drug: Dasatinib |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II Study of BMS-354825 in Subjects With Lymphoid Blast Phase Chronic Myeloid Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Resistant to or Intolerant of Imatinib Mesylate |
| Enrollment: | 96 |
| Study Start Date: | January 2005 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: Dasatinib
Tablets, Oral, 70 mg, twice daily, Until disease progression or untolerable toxicity, switch to the roll-over study or study closure
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Subjects who received any of the following:
Contacts and Locations
Show 60 Study Locations| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
| Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
| Study ID Numbers: | CA180-015 |
| Study First Received: | January 12, 2005 |
| Last Updated: | February 4, 2010 |
| ClinicalTrials.gov Identifier: | NCT00101595 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Lymphoid blast phase chronic myeloid leukemia Philadelphia chromosome positive acute lymphoblastic leukemia |
|
Philadelphia Chromosome Blast Crisis Leukemia, Lymphoid Molecular Mechanisms of Pharmacological Action Protein Kinase Inhibitors Leukemia Neoplastic Processes Pathologic Processes Dasatinib Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Immune System Diseases |
Hematologic Diseases Myeloproliferative Disorders Enzyme Inhibitors Leukemia, Myeloid Pharmacologic Actions Translocation, Genetic Lymphatic Diseases Neoplasms Chromosome Aberrations Leukemia, Myelogenous, Chronic, BCR-ABL Positive Bone Marrow Diseases Lymphoproliferative Disorders Cell Transformation, Neoplastic |