Status:
COMPLETED
Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Myeloid Leukemia, Chronic, Chronic-Phase
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief Summary
This is a phase III study of BMS-354825 in subjects with chronic phase Philadelphia chromosome or BCR-ABL positive chronic myelogenous leukemia, who are resistant or intolerant to imatinib mesylate (G...
Eligibility Criteria
Inclusion
- For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
- Subjects with Philadelphia chromosome positive (Ph+) (or BCR/ABL+) chronic phase chronic myeloid leukemia whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate.
- Men and women, 18 years 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.
Exclusion
- Women who are pregnant or breastfeeding
- Subjects who are eligible and willing to undergo transplantation during the screening period
- 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
- 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 :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
724 Patients enrolled
Trial Details
Trial ID
NCT00123474
Start Date
July 1 2005
End Date
July 1 2014
Last Update
August 25 2016
Active Locations (137)
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1
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
2
Central Hematology Oncology Medical Group Inc.
Alhambra, California, United States, 91801
3
Pacific Cancer Medical Center Inc
Anaheim, California, United States, 92801
4
Loma Linda University Cancer Center
Loma Linda, California, United States, 92354