Back to resultsA Study of Dasatinib in Patients With Chronic Myelogenous Leukemia Who Are Resistant or Intolerant of Imatinib Mesylate
Primary Purpose
Leukemia, Myeloid, Chronic, Leukemia, Lymphocytic, Acute, L2
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Dasatinib
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia, Myeloid, Chronic focused on measuring Chronic Myeloid Leukemia Accelerated and Blast Phase, Leukemia, Acute, Philadelphia-Positive
Eligibility Criteria
Inclusion Criteria: Diagnosis of accelerated phase or blast phase CML or Ph+ ALL Intolerant or resistant to imatinib mesylate 18 years of age or older ECOG performance 0-2 (greater than 50% of time out of bed) Adequate liver and kidney function Exclusion Criteria: Pregnant or breastfeeding females History of significant cardiac disease History of significant bleeding disorder (not CML) Prisoners
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Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A1
Arm Description
Outcomes
Primary Outcome Measures
Provide therapy to patients for which there is no therapeutic alternative
Secondary Outcome Measures
Safety data collection
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00298987
Brief Title
A Study of Dasatinib in Patients With Chronic Myelogenous Leukemia Who Are Resistant or Intolerant of Imatinib Mesylate
Official Title
Study of Dasatinib (BMS-354825) in Subjects With Chronic Myelogenous Leukemia With Accelerated or Myeloid or Lymphoid Blast Phase or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant to or Intolerant of Imatinib Mesylate
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
5. Study Description
Brief Summary
The purpose of this clinical research study is to provide dasatinib treatment to patients with advanced chronic myelogenous leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who no longer can tolerate treatment with imatinib. The safety of the treatment will also be studied.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid, Chronic, Leukemia, Lymphocytic, Acute, L2
Keywords
Chronic Myeloid Leukemia Accelerated and Blast Phase, Leukemia, Acute, Philadelphia-Positive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dasatinib
Other Intervention Name(s)
Sprycel
Intervention Description
Tablets, Oral, 70 mg, Twice daily, 2 months.
Primary Outcome Measure Information:
Title
Provide therapy to patients for which there is no therapeutic alternative
Secondary Outcome Measure Information:
Title
Safety data collection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of accelerated phase or blast phase CML or Ph+ ALL
Intolerant or resistant to imatinib mesylate
18 years of age or older
ECOG performance 0-2 (greater than 50% of time out of bed)
Adequate liver and kidney function
Exclusion Criteria:
Pregnant or breastfeeding females
History of significant cardiac disease
History of significant bleeding disorder (not CML)
Prisoners
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
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Local Institution
City
Corona
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California
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United States
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Aurora
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Colorado
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United States
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Colorado Springs
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Colorado
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United States
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Waterford
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Connecticut
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United States
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Daytona Beach
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Florida
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United States
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Jupiter
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Florida
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United States
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Atlanta
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Georgia
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United States
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Lawrenceville
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Georgia
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United States
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Beach Grove
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Indiana
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United States
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Indianapolis
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Indiana
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United States
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Iowa City
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Iowa
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United States
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Kansas City
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Kansas
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United States
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Salina
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United States
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Lexington
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Kentucky
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United States
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Louisville
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United States
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Boston
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United States
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Ann Arbor
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United States
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Detroit
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United States
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Santa Fe
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New Mexico
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United States
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New York
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New York
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United States
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Cincinnati
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Ohio
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United States
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Cleveland
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Ohio
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United States
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Lawton
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Oklahoma
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United States
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Tulsa
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Oklahoma
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United States
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Portland
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Oregon
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United States
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Providence
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Rhode Island
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United States
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Charleston
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South Carolina
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United States
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Chattanooga
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United States
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Spokane
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United States
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Sheboygan
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Wisconsin
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United States
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Edmonton
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Alberta
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Canada
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Vancouver
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British Columbia
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Canada
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Hamilton
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Ontario
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Canada
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Toronto
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Ontario
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Canada
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Montreal
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Quebec
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Canada
12. IPD Sharing Statement
Learn more about this trial
A Study of Dasatinib in Patients With Chronic Myelogenous Leukemia Who Are Resistant or Intolerant of Imatinib Mesylate
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