Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML

Completed · Phase 3

Conditions studied: Myeloid Leukemia, Chronic, Chronic-Phase

In brief

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 (Gleevec).

Key facts

Study ID

NCT00123474

Run by

Bristol-Myers Squibb

People needed

724

Starts

2005-07-01

Expected to finish

2014-07-01

Last updated by the study team

2016-08-25

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Central Hematology Oncology Medical Group Inc. — Alhambra, California, United States
• Pacific Cancer Medical Center Inc — Anaheim, California, United States
• Loma Linda University Cancer Center — Loma Linda, California, United States
• Pacific Shores Medical Group — Long Beach, California, United States
• Ucla Dept. Of Medicine — Los Angeles, California, United States
• Ventura County Hematology-Oncology Specialists — Oxnard, California, United States
• Kaiser Permanente Medical Center — Vallejo, California, United States
• Georgetown University Med Ctr — Washington D.C., District of Columbia, United States
• Washington Cancer Institute At Washington Hospital Center — Washington D.C., District of Columbia, United States
• University Of Florida — Gainesville, Florida, United States
• University Of Miami — Miami, Florida, United States
• Md Anderson Cancer Center Orlando — Orlando, Florida, United States
• Emory University School Of Medicine — Atlanta, Georgia, United States
• Georgia Cancer Specialists — Atlanta, Georgia, United States
• Gwinnett Hospital System Inc. — Lawrenceville, Georgia, United States
• Northwestern University Feinberg School Of Medicine — Chicago, Illinois, United States
• University Of Chicago — Chicago, Illinois, United States
• Oncology Hematology Associates Of Central Illinois, Pc — Peoria, Illinois, United States
• Indiana University Cancer Center — Indianapolis, Indiana, United States
• University Of Kansas Medical Center — Westwood, Kansas, United States
• University Of Kentucky — Lexington, Kentucky, United States
• University Of Maryland — Baltimore, Maryland, United States
• Dana Faber Cancer Institute — Boston, Massachusetts, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• University Of Alabama At Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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