Clinical trial NCT00345826 (phase 1, status: completed)
Conditions: leukemia
ICD codes: C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01
Drugs: dasatinib
SMILES: CC1=NC(NC2=NC=C(S2)C(=O)NC2=C(C)C=CC=C2Cl)=CC(=N1)N1CCN(CCO)CC1
Eligibility criteria:

        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