Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML
Condition: Myeloid Leukemia, Chronic, Chronic-Phase
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase
Intervention: dasatinib; dasatinib; dasatinib; dasatinib
Intervention description: Tablets, Oral, 50 mg BID, indefinitely, survival study; Tablets, Oral, 70 mg BID, indefinitely, survival study; Tablets, Oral, 100 mg QD, indefinitely, survival study; Tablets, Oral, 140 mg QD, indefinitely, survival study
Intervention MeSH terms: Dasatinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 724.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Chronic Phase Chronic Myelogenous Leukemia

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 (Gleevec).
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Inclusion Criteria:

          -  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 Criteria:

          -  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