Study of Dasatinib (BMS-354825) in Patients With Accelerated Phase Chronic Myeloid Leukemia
Condition: Chronic Myelogenous Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Accelerated Phase
Intervention: Dasatinib
Intervention description: Tablets, Oral, 70 mg, twice daily, until disease progression or intolerable toxicity, switch to the roll-over study or study closure
Intervention MeSH terms: Dasatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 197.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic myelogenous leukemia (CML): Accelerated phase

Summary:

      The purpose of this clinical research study is to learn if BMS-354825 will have activity,
      defined by hematologic response, in subjects who have accelerated phase chronic myeloid
      leukemia (CML) who are resistant to or intolerant to imatinib mesylate. The safety of this
      treatment will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with Philadelphia chromosome positive (PH+) or the fused gene BCR/ABL
             positive (BCR/ABL+) accelerated phase chronic myeloid leukemia (CML) whose disease has
             primary or acquired hematologic resistance to imatinib mesylate or who are intolerant
             of imatinib mesylate.

          -  Subjects must have had prior exposure to imatinib. However, imatinib mesylate does not
             need to be their most recent CML treatment prior to coming on this study.

          -  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 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 subjects 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 dasatinib (BMS-354825).

          -  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.