Clinical trial · Interventional
Dasatinib in Treating Patients With Chronic Myelogenous Leukemia or Acute Lymphoblastic Leukemia
Long-Term Safety and Efficacy of Dasatinib (BMS-354825) in Subjects Who Experienced Clinical Benefit on Protocol CA 180-002
NCT00345826CI-TRIAL-00008824completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 patients with chronic myelogenous leukemia or acute lymphoblastic leukemia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dasatinib | Drug | Dasatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dasatinib
- interventionNames
- Drug: dasatinib
Primary outcomes (1)
- measure
- Long term safety and tolerability
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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-0303035References
Publications (1)
- RESULTTalpaz M, Shah NP, Kantarjian H, Donato N, Nicoll J, Paquette R, Cortes J, O'Brien S, Nicaise C, Bleickardt E, Blackwood-Chirchir MA, Iyer V, Chen TT, Huang F, Decillis AP, Sawyers CL. Dasatinib in imatinib-resistant Philadelphia chromosome-positive leukemias. N Engl J Med. 2006 Jun 15;354(24):2531-41. doi: 10.1056/NEJMoa055229. PMID 16775234