Phase I Study of BMS-354825 in Patients With Chronic Accelerated, or Blast Phase Chronic Myelogenous Leukemia or Philadelphia Positive Acute Lymphoblastic Leukemia
- 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.
- Patients who are eligible and willing to undergo transplantation during the screening
- 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.