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Study of Dasatinib in Patients With Chronic Myelogenous Leukemia
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, August 2008
Sponsors and Collaborators: M.D. Anderson Cancer Center
Bristol-Myers Squibb
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00254423
  Purpose

The goal of this clinical research study is to learn if BMS-354825 (dasatinib) can help to control CML in chronic phase. The safety of this drug will also be studied.

Optional Procedures: You will be asked to have extra blood and/or bone marrow samples taken. These samples will be used to study the effect of the treatment on leukemia cells.


Condition Intervention Phase
Chronic Myelogenous Leukemia
Drug: Dasatinib (BMS-354825)
Drug: Dasatinib
Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood
Drug Information available for: Dasatinib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title: Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With Dasatinib (BMS-354825)

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To estimate the proportion of patients with previously-untreated chronic phase CML attaining major molecular response by 12 months of treatment with dasatinib. [ Time Frame: November 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To investigate the effect of different dose schedules of dasatinib in efficacy and tolerability. [ Time Frame: September 2010 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2005
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Dasatinib
Drug: Dasatinib (BMS-354825)
Dasatinib 100 mg orally, daily
2: Experimental
Dasatinib
Drug: Dasatinib
Dasatinib 50 mg orally twice daily

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Ph-positive or Bcr-positive CML in early chronic phase CML (i.e., time from diagnosis </= 12 months). Except for hydroxyurea, patients must have received no or minimal prior therapy, defined as <1 month of prior IFN-alpha (with or without ara-C) and/or imatinib
  • Continued from above #1: Clonal evolution defined as the presence of additional chromosomal abnormalities other than the Ph chromosome has been historically been included as a criterion for accelerated phase. However, patients with clonal evolution as the only criterion of accelerated phase have a significantly better prognosis, and when present at diagnosis may not impact the prognosis at all. Thus, patients with clonal evolution and no other criteria for accelerated phase will be eligible for this study
  • Age >/= 16 years
  • ECOG performance of 0-2
  • Adequate end organ function, defined as the following: total bilirubin <1.5 x ULN, SGPT <2.5x ULN, creatinine <1.5x ULN
  • Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.

Exclusion Criteria:

  • New York Heart Association (NYHA) cardiac class 3-4 heart disease
  • Cardiac Symptoms: Patients meeting the following criteria are not eligible: Uncontrolled angina within 3 months; Diagnosed or suspected congenital long QT syndrome; Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes); Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec) on both the Fridericia and Bazett's correction; Uncontrolled hypertension; History of significant bleeding disorder unrelated to cancer, including:
  • Cont: Diagnosed congenital bleeding disorders (von Willebrand's disease) Diagnosed acquired bleeding disorder w/in 1 year (acquired anti-factor VIII antibodies);Pts currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes including: quinidine, procainamide, disopyramide amiodarone, sotalol, ibutilide, dofetilide erythromycins, clarithromycin chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine.
  • Patients with active, uncontrolled psychiatric disorders including: psychosis, major depression, and bipolar disorders
  • Women of pregnancy potential must practice an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized.Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
  • Continued: In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control. Women and men must continue birth control for the duration of the trial and at least 3 months after the last dose of study drug; Pregnant or breast-feeding women are excluded; All WOCBP MUST have a negative pregnancy test prior to first receiving investigational product. If the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study.
  • Patients in late chronic phase (i.e., time from diagnosis to treatment >12 months), accelerated or blast phase are excluded.
  • The definitions of CML phases are as follows: a) Early chronic phase: time from diagnosis to therapy </= 12 months; Late chronic phase: time from diagnosis to therapy > 12 months, b) Blastic phase: presence of 30% blasts or more in the peripheral blood or bone marrow, c) Accelerated phase CML: presence of any of the following features: •Peripheral or marrow blasts 15% or more, •Peripheral or marrow basophils 20% or more, •Thrombocytopenia < 100 x 10^9/L unrelated to therapy, • Documented extramedullary blastic disease outside liver or spleen
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00254423

Contacts
Contact: Jorge Cortes, MD 713-794-5783

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Jorge Cortes, MD            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Bristol-Myers Squibb
Investigators
Principal Investigator: Jorge Cortes, MD U.T.M.D. Anderson Cancer Center
  More Information

M.D. Anderson's Website  This link exits the ClinicalTrials.gov site

Responsible Party: The University of Texas M. D. Anderson Cancer Center ( Jorge Cortes M.D./Professor )
Study ID Numbers: 2005-0422
Study First Received: November 14, 2005
Last Updated: August 22, 2008
ClinicalTrials.gov Identifier: NCT00254423  
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Chronic Myelogenous Leukemia
Dasatinib
BMS-354825

Study placed in the following topic categories:
Leukemia
Chronic myelogenous leukemia
Hematologic Diseases
Dasatinib
Myeloproliferative Disorders
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Leukemia, Myeloid
Bone Marrow Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009