Study of BMS-354825 (Dasatinib) in Patients With Chronic Myeloid Leukemia Who Are Either Resistant or Intolerant to Imatinib
Condition: Chronic Myeloid Leukemia; Philadelphia-Positive Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Philadelphia Chromosome
Intervention: Dasatinib
Intervention description: Tablets; oral; 70 mg BID, depending on response
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: 387.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic phase Philadelphia chromosome chronic myeloid leukemia (Ph+CML)

Summary:

      The purpose of this study is assess the effects of the investigational drug dasatinib on
      participants who are in chronic phase Philadelphia chromosome chronic myeloid leukemia and
      who are either resistant to or intolerant of imatinib. Other purposes of the study are to
      identify any side effects the drug may produce and to study the level of dasatanib in the
      blood and assess the efficacy of dasatanib in the treatment of leukemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age of 18 years and older.

          -  Chronic myeloid leukemia (CML)

          -  Previous treatment with imatinib at a dose of >600 mg/day AND the development of
             progressive disease while receiving imatinib at that dose, OR

          -  CML with resistance to imatinib at a dose less than or equal to 600 mg/day with
             genetic mutation in the BCR-ABL gene that is associated with a high level of
             resistance to imatinib, OR

          -  Intolerance to imatinib at any dose

          -  Adequate organ function

          -  Women who are able to bear children must have a negative serum or urine pregnancy
             test. Adequate methods of contraception must be used throughout the study to avoid
             pregnancy for the entire interval of at least 1 month before and 3 months after
             completion of the study medication.

        Exclusion Criteria:

          -  Woman who are pregnant or breastfeeding

          -  Men whose sexual partners are women who are of childbearing potential, and who are
             unwilling or unable to use an acceptable method to avoid pregnancy of his partner for
             the entire study period as outlined above

          -  Previous diagnosis of accelerated phase or blast crisis CML.

          -  Participants who are eligible and willing to undergo transplantation during the
             screening period

          -  Uncontrolled or significant cardiovascular disease

          -  Use of imatinib within 7 days.

          -  Use of interferon or cytarabine within 14 days

          -  Use of a targeted small-molecule anticancer agent within 14 days

          -  Use of certain medication that carry a known side effect risk of Torsade de Pointes -
             Certain medications that irreversibly inhibit platelet function or anticoagulants

          -  Prior therapy with dasatinib.