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

Completed · Phase 3

Conditions studied: Myeloid Leukemia, Chronic, Accelerated Phase, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive

In brief

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 lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).

Key facts

Study ID

NCT00123487

Run by

Bristol-Myers Squibb

People needed

638

Starts

2005-06-01

Expected to finish

2013-06-01

Last updated by the study team

2014-11-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Loma Linda University Cancer Center — Loma Linda, California, United States
• Ucla Dept. Of Medicine — Los Angeles, California, United States
• Washington Cancer Institute At Washington Hospital Center — Washington D.C., District of Columbia, United States
• University Of Miami — Miami, Florida, United States
• Emory University School Of Medicine — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• The University Of Chicago — Chicago, Illinois, United States
• Indiana University Cancer Center — Indianapolis, Indiana, 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 Center — Detroit, Michigan, United States
• Washington University School Of Medicine — St Louis, Missouri, United States
• Nebraska Methodist Hospital — Omaha, Nebraska, United States
• Devetten, Marcel — Omaha, Nebraska, United States
• The Cancer Center At Hackensack University Medical Center — Hackensack, New Jersey, United States
• The Cancer Institute Of New Jersey — New Brunswick, New Jersey, United States
• New York Presbyterian Hospital — New York, New York, United States
• The University Of North Carolina At Chapel Hill — Chapel Hill, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Oregon Health & Sci Univ — Portland, Oregon, United States
• Western Pennsylvania Cancer Institute — Pittsburgh, Pennsylvania, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• The University Of Texas Md Anderson Cancer Center — Houston, Texas, United States
• University Of Alabama At Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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