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

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Dasatinib

Criteria

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.