BMS-354825 in Patients With Chronic Accelerated, or Blast Phase Chronic Myelogenous Leukemia or Philadelphia Positive Acute Lymphoblastic Leukemia

Study Overview
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Brief Summary
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The purpose of this clinical research study is to understand the safety and efficacy of BMS-354825 in patients with chronic, accelerated, or blast phase chronic myelogenous leukemia (CML) or Philadelphia positive acute lymphoblastic leukemia (ALL) who are resistant to or intolerant of imatinib mesylate (Gleevec).

Official Title
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Phase I Study of BMS-354825 in Patients With Chronic Accelerated, or Blast Phase Chronic Myelogenous Leukemia or Philadelphia Positive Acute Lymphoblastic Leukemia

Conditions
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Leukemia, Myeloid, Chronic-phase, Leukemia, Lymphoblastic, Acute, Philadelphia-positive

Intervention / Treatment
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* Drug: Dasatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Philadelphia chromosome positive, chronic, accelerated or blast phase BML or ALL. Patients must have primary or acquired hematologic resistance to imatinib mesylate or have intolerance of imatinib mesylate. Men and women, 14 years of age or older. Adequate renal function. Adequate hepatic function. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized. Exclusion Criteria: Patients who are eligible and willing to undergo transplantation during the screening period. Women who are pregnant or breastfeeding. A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy. Uncontrolled or significant cardiovascular disease. Medications that increase bleeding risk. Medications that change heart rhythms. Dementia or altered mental status that would prohibit the understanding of rendering of informed consent. History of significant bleeding disorder or unrelated to CML. Evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Dasatinib<br>* Tablets, Oral, 15- 240 mg, Once or twice daily, 0-3 years depending on response.<br>* Other names: Sprycel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establishment of MTD and recommended Phase II dose. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1) Hematologic Response 2) Cytogenetic Response. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic myelogenous leukemia (CML) chronic, accelerated, blast phase, Philadelphia chromosome positive acute (Ph+ALL)