Dasatinib as Therapy for Myeloproliferative Disorders (MPDs)
Condition: Acute Myeloid Leukemia; Myelodysplastic Syndromes; Agnogenic Myeloid Metaplasia; Myelofibrosis; Hypereosinophilic Syndrome; Polycythemia Vera; Mastocytosis; Leukemia, Myelomonocytic, Chronic
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Polycythemia Vera; Mastocytosis; Leukemia, Myelomonocytic, Chronic; Myelodysplastic Syndromes; Primary Myelofibrosis; Polycythemia; Hypereosinophilic Syndrome; Syndrome; Metaplasia
Intervention: Dasatinib (BMS-354825)
Intervention description: 70 mg orally twice daily
Intervention MeSH terms: Dasatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: targeted therapy; leukemia; Acute myeloid leukemia (AML); Myelodysplastic syndrome (MDS); Agnogenic myeloid metaplasia - myelofibrosis (MMM); Hypereosinophilic syndrome (HES); Polycythemia vera (PV); Mastocytosis; CMML

Summary:

      The goal of this clinical research study is to learn if dasatinib can help to control
      myeloproliferative disorders. The safety and tolerability of dasatinib will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients >/= 18 years old who meet the following eligibility criteria

          2. Patients must have one of the following hematopoietic malignancies: C-kit positive
             (10% or more BM or PB MNC positive by flow) acute myeloid leukemia (AML excluding
             acute promyelocytic leukemia) or myelodysplastic syndrome (MDS) of the following
             types: Refractory-relapse AML-MDS including those who fail to achieve Complete
             Response (CR) after the first cycle of induction; Second or subsequent AML-MDS
             refractory-relapse; Newly diagnosed AML-MDS patients over 60 years of age with
             karyotype other than t(15:17), inv16, t(8:21), who do not want chemotherapy.

          3. (Con't from # 2) Patients with MDS who do not want chemotherapy as initial treatment,
             or who are not eligible for the treatments of higher priority.

          4. Agnogenic myeloid metaplasia - myelofibrosis (MMM)

          5. Hypereosinophilic syndrome (HES)

          6. Polycythemia vera (PV)

          7. Mastocytosis

          8. Serum bilirubin less than 2mg%, serum creatinine less than 2mg% unless abnormality is
             considered due to hematologic malignancy by investigator.

          9. Eastern Cooperative Oncology Group (ECOG) Performance Status < 3

         10. Patients must sign an informed consent indicating they are aware of the
             investigational nature of this study, in keeping with the policies of the hospital.

         11. Women of pregnancy potential must practice an effective method of birth control during
             the course of the study, in a manner such that risk of failure is minimized. Prior to
             study enrollment, women of childbearing potential (WOCBP) (defined as not
             post-menopausal for 12 months or no previous surgical sterilization) must be advised
             of the importance of avoiding pregnancy during trial participation and the potential
             risk factors for an unintentional pregnancy.

         12. Continued from #11: In addition, men enrolled on this study should understand the
             risks to any sexual partner of childbearing potential and should practice an effective
             method of birth control.Women and men must continue birth control for the duration of
             the trial and at least 3 months after the last dose of study drug.

         13. Inclusion of women and minorities: As per NIH policy, women and members of minorities
             will be included in this protocol as they are referred in the relevant populations.
             There are no exclusions of women or minorities based on the study objectives.

         14. New York Heart Association (NYHA) Class < 3

         15. Ph negative MPD including chronic myelomonocytic leukemia (CMML).

        Exclusion Criteria:

          1. Pregnant or breast-feeding women are excluded.

          2. All WOCBP MUST have a negative pregnancy test prior to first receiving investigational
             product. If the pregnancy test is positive, the patient must not receive
             investigational product and must not be enrolled in the study.