Status:
COMPLETED
BMS-354825 in Patients With Chronic Accelerated, or Blast Phase Chronic Myelogenous Leukemia or Philadelphia Positive Acute Lymphoblastic Leukemia
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Leukemia, Myeloid, Chronic-phase
Leukemia, Lymphoblastic, Acute, Philadelphia-positive
Eligibility:
All Genders
14+ years
Phase:
PHASE1
Brief 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 Philadelp...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00103701
Start Date
November 1 2003
End Date
March 1 2006
Last Update
April 14 2011
Active Locations (2)
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1
Local Institution
Los Angeles, California, United States
2
Local Institution
Houston, Texas, United States