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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia, Myeloid, Chronic, Leukemia, Lymphocytic, Acute, L2

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Provide therapy to patients for which there is no therapeutic alternative

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA180-033

NCT ID:

NCT00298987

Start Date:

February 2006

Completion Date:

June 2007

Related Keywords:

  • Leukemia, Myeloid, Chronic
  • Leukemia, Lymphocytic, Acute, L2
  • Chronic Myeloid Leukemia Accelerated and Blast Phase
  • Leukemia, Acute, Philadelphia-Positive
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Philadelphia Chromosome

Name

Location
Local Institution Indianapolis, Indiana  
Local Institution Bronx, New York  
Local Institution Cincinnati, Ohio  
Local Institution Portland, Oregon  
Local Institution Vancouver, Washington  
Local Institution Green Bay, Wisconsin  
Local Institution Corona, California  
Local Institution Aurora, Colorado  
Local Institution Hamden, Connecticut  
Local Institution Fort Lauderdale, Florida  
Local Institution Wichita, Kansas  
Local Institution Springfield, Massachusetts  
Local Institution Albuquerque, New Mexico  
Local Institution Oklahoma City, Oklahoma  
Local Institution North Charleston, South Carolina  
Local Institution Rome, Georgia  
Local Institution Providence, Rhode Island  
Local Institution Chattanooga, Tennessee  
Local Institution Iowa City, Iowa  
Local Institution Louisville, Kentucky  
Local Institution Detroit, Michigan