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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 InstitutionIndianapolis, Indiana  
Local InstitutionBronx, New York  
Local InstitutionCincinnati, Ohio  
Local InstitutionPortland, Oregon  
Local InstitutionVancouver, Washington  
Local InstitutionGreen Bay, Wisconsin  
Local InstitutionCorona, California  
Local InstitutionAurora, Colorado  
Local InstitutionHamden, Connecticut  
Local InstitutionFort Lauderdale, Florida  
Local InstitutionWichita, Kansas  
Local InstitutionSpringfield, Massachusetts  
Local InstitutionAlbuquerque, New Mexico  
Local InstitutionOklahoma City, Oklahoma  
Local InstitutionNorth Charleston, South Carolina  
Local InstitutionRome, Georgia  
Local InstitutionProvidence, Rhode Island  
Local InstitutionChattanooga, Tennessee  
Local InstitutionIowa City, Iowa  
Local InstitutionLouisville, Kentucky  
Local InstitutionDetroit, Michigan