Status:
COMPLETED
Advanced Chronic Myelogenous Leukemia (CML) - Follow On: Study of BMS-354825 in Subjects With CML
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Myeloid Leukemia, Chronic, Accelerated Phase
Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute l...
Eligibility Criteria
Inclusion
- For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
- Patients with Philadelphia-Positive (Ph+) (or BCR/ABL+) accelerated phase chronic myeloid leukemia, Ph+ (or BCR/ABL+) blast phase chronic myeloid leukemia, or Ph+ (or BCR/ABL+) acute lymphoblastic leukemia whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate
- Men and women, 18 years of age or older
- Adequate hepatic function
- Adequate renal 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
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2
Exclusion
- 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 or rendering of informed consent
- History of significant bleeding disorder unrelated to CML
- Concurrent incurable malignancy other than CML
- Evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy
- Prior therapy with BMS-35425
- 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 :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
638 Patients enrolled
Trial Details
Trial ID
NCT00123487
Start Date
June 1 2005
End Date
June 1 2013
Last Update
November 3 2014
Active Locations (119)
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1
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
2
Loma Linda University Cancer Center
Loma Linda, California, United States, 92354
3
Ucla Dept. Of Medicine
Los Angeles, California, United States, 90095
4
Washington Cancer Institute At Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010