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

NCT00345826 | Completed Phase 1 DMC

• 3 other identifiers: CDR0000480396UCLA-0509010-01BMS-CA180039
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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 patients with chronic myelogenous leukemia or acute lymphoblastic leukemia.

Conditions

Leukemia

Keywords

accelerated phase chronic myelogenous leukemia; blastic phase chronic myelogenous leukemia; chronic phase chronic myelogenous leukemia; relapsing chronic myelogenous leukemia; recurrent adult acute lymphoblastic leukemia; chronic myelogenous leukemia, BCR-ABL1 positive

Outcome Measures

Primary Outcomes (1)

• Long term safety and tolerability

  5 years

Study Arms (1)

Dasatinib

EXPERIMENTAL

Drug: dasatinib

Interventions

dasatinib DRUG

Dasatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

Related Publications (1)

• Talpaz 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 RESULT

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Accelerated Phase; Blast Crisis; Leukemia, Myeloid, Chronic-Phase; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Charles Sawyers, MD

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2006
• First Posted: June 29, 2006
• Study Start: November 1, 2005
• Primary Completion: July 1, 2010
• Last Updated: January 8, 2013

Record last verified: 2013-01

Locations

US (1)