Status:
COMPLETED
Dasatinib in Treating Patients With Chronic Myelogenous Leukemia or Acute Lymphoblastic Leukemia
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects of dasatinib in treating pati...
Detailed Description
OBJECTIVES: Primary * Determine the long-term safety and tolerability of dasatinib in patients with Philadelphia chromosome-positive chronic myelogenous leukemia or acute lymphoblastic leukemia resi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00345826
Start Date
November 1 2005
Last Update
January 8 2013
Active Locations (1)
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1
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781