Dasatinib in Treating Patients With Chronic Myelogenous Leukemia or Acute Lymphoblastic Leukemia

DISEASE CHARACTERISTICS:

• Diagnosis of one of the following hematologic malignancies:

  • Chronic phase chronic myelogenous leukemia (CML)

    • In complete hematologic response after treatment on protocol UCLA-0303035, as indicated by the following criteria:

      • WBC ≤ upper limit of normal (ULN)
      • Platelet count < 450,000/mm^3
      • No blasts or promyelocytes in peripheral blood
      • Less than 5% myelocytes plus metamyelocytes in peripheral blood
      • Peripheral blood basophils ≤ ULN
      • No extramedullary involvement (including no hepatomegaly or splenomegaly)
      • Response lasting ≥ 4 weeks after first documentation

  • Accelerated or blastic phase CML or acute lymphoblastic leukemia

    • In major hematologic response* after treatment on protocol UCLA-0303035, defined as 1 of the following:

      • In complete hematologic response*, as indicated by the following criteria:

        • WBC ≤ ULN
        • Absolute neutrophil count ≥ 1,000/mm^3
        • Platelet count ≥ 100,000/mm^3
        • No blasts or promyelocytes in peripheral blood
        • Bone marrow blasts ≤ 5%
        • Less than 5% myelocytes plus metamyelocytes in peripheral blood
        • Peripheral blood basophils ≤ ULN
        • No extramedullary involvement (including no hepatomegaly or splenomegaly)

      • No evidence of leukemia, as indicated by the following criteria:

        • WBC ≤ ULN
        • No blasts or promyelocytes in the peripheral blood
        • Bone marrow blasts ≤ 5%
        • Less than 5% myelocytes plus metamyelocytes in peripheral blood
        • Peripheral blood basophils ≤ ULN
        • No extramedullary involvement (including no hepatomegaly or splenomegaly)
        • Absolute neutrophil count ≥ 500/mm^3 and < 1,000/mm^3 AND platelet count ≥ 20,000/mm^3 and < 100,000/mm^3

    • In minor hematologic response* after treatment on protocol UCLA-0303035, as indicated by the following criteria:

      • Less than 15% in bone marrow and < 15% in peripheral blood
      • Less than 30% blasts plus promyelocytes in bone marrow and < 30% blasts plus promyelocytes in peripheral blood
      • Less than 20% basophils in peripheral blood
      • No extramedullary disease other than spleen and liver NOTE: *Response confirmed after ≥ 4 weeks allowed provided there is no concurrent anagrelide or hydroxyurea during this time
• Philadelphia chromosome-positive (Ph+) disease
• Resistant or intolerant to prior imatinib mesylate
• Received and benefitted from ≥ 3 months of prior therapy with dasatinib on protocol UCLA-0303035

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 12 weeks after completion of study treatment
• No serious uncontrolled medical disorder
• No active infection that would preclude study participation
• No uncontrolled angina within the past 3 months
• No diagnosed or suspected congenital long QT syndrome
• No history of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or torsades de pointes)
• QTc ≤ 450 msec on electrocardiogram
• No uncontrolled hypertension
• No dementia or altered mental status the would prohibit the understanding or rendering of informed consent

• No history of the following significant bleeding disorders unrelated to CML:

  • Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
  • Diagnosed acquired bleeding disorder in the past year (e.g., acquired antifactor VIII antibodies)
• Not involuntarily incarcerated for either psychiatric or physical (e.g., infectious disease) illness
• No patients who are imprisoned
• No clinical adverse event, laboratory abnormality, or intercurrent illness that may preclude study treatment, in the opinion of the investigator
• Bilirubin < 1.5 mg/dL
• ALT and AST < 2 times upper limit of normal (ULN)
• Creatinine < 1.5 times ULN

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No concurrent use of the following drugs that may confer risk of torsades de pointes:

  • Quinidine
  • Procainamide
  • Disopyramide
  • Amiodarone
  • Sotalol
  • Ibutilide
  • Dofetilide
  • Erythromycin
  • Clarithromycin
  • Chlorpromazine
  • Haloperidol
  • Mesoridazine
  • Thioridazine
  • Pimozide
  • Cisapride
  • Bepridil
  • Droperidol
  • Methadone
  • Arsenic
  • Chloroquine
  • Domperidone
  • Halofantrine
  • Levomethadyl
  • Pentamidine
  • Sparfloxacin
  • Lidoflazine
• No other concurrent treatment for CML except for hydroxyurea for a 2-week duration
• No concurrent medications that inhibit platelet function (e.g., aspirin, dipyridamole, epoprostenol, eptifibatide, clopidogrel, cilostazol, abciximab, ticlopidine, or any nonsteroidal anti-inflammatory drug)* except for hydroxyurea or anagrelide
• No concurrent anticoagulants (e.g., warfarin or heparin/low molecular weight heparin [e.g., danaparoid, dalteparin, tinzaparin, or enoxaparin]) except as prophylaxis for catheter thrombosis and/or heparin flushes for IV lines* NOTE: *Allowed if received previously on UCLA-0303035