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A Phase II Study to Determine the Activity of BMS-354825 in Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Disease That is Resistant to High Dose Imatinib Mesylate (Gleevec) or Who Are Intolerant of Imatinib


Phase 2
18 Years
N/A
Not Enrolling
Both
Chronic Myeloid Leukemia, Philadelphia-Positive Myeloid Leukemia

Thank you

Trial Information

A Phase II Study to Determine the Activity of BMS-354825 in Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Disease That is Resistant to High Dose Imatinib Mesylate (Gleevec) or Who Are Intolerant of Imatinib


Inclusion Criteria:



- Age of 18 years and older.

- Chronic myeloid leukemia (CML)

- Previous treatment with imatinib at a dose of >600 mg/day AND the development of
progressive disease while receiving imatinib at that dose, OR

- CML with resistance to imatinib at a dose less than or equal to 600 mg/day with
genetic mutation in the BCR-ABL gene that is associated with a high level of
resistance to imatinib, OR

- Intolerance to imatinib at any dose

- Adequate organ function

- Women who are able to bear children must have a negative serum or urine pregnancy
test. Adequate methods of contraception must be used throughout the study to avoid
pregnancy for the entire interval of at least 1 month before and 3 months after
completion of the study medication.

Exclusion Criteria:

- Woman who are pregnant or breastfeeding

- Men whose sexual partners are women who are of childbearing potential, and who are
unwilling or unable to use an acceptable method to avoid pregnancy of his partner for
the entire study period as outlined above

- Previous diagnosis of accelerated phase or blast crisis CML.

- Participants who are eligible and willing to undergo transplantation during the
screening period

- Uncontrolled or significant cardiovascular disease

- Use of imatinib within 7 days.

- Use of interferon or cytarabine within 14 days

- Use of a targeted small-molecule anticancer agent within 14 days

- Use of certain medication that carry a known side effect risk of Torsade de Pointes
- Certain medications that irreversibly inhibit platelet function or anticoagulants

- Prior therapy with dasatinib.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Imatinib-resistant Participants With Major Cytogenetic Response (MCyR)

Outcome Description:

Cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of Complete Cytogenetic Response (CCyR)-0% Ph+ metaphases plus Partial Cytogenetic Response (PCyR)-1% to 35% Ph+ metaphases.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA180-013

NCT ID:

NCT00101660

Start Date:

February 2005

Completion Date:

April 2008

Related Keywords:

  • Chronic Myeloid Leukemia
  • Philadelphia-Positive Myeloid Leukemia
  • Chronic phase Philadelphia chromosome chronic myeloid leukemia (Ph+CML)
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Philadelphia Chromosome

Name

Location

Local Institution Chicago, Illinois  
Local Institution Indianapolis, Indiana  
Local Institution Baltimore, Maryland  
Local Institution Bronx, New York  
Local Institution Portland, Oregon  
Local Institution Vancouver, Washington  
Local Institution Corona, California  
Local Institution Hamden, Connecticut  
Local Institution Washington, District of Columbia  
Local Institution Fort Lauderdale, Florida  
Local Institution Wichita, Kansas  
Local Institution Springfield, Massachusetts  
Local Institution Lincoln, Nebraska  
Local Institution New Brunswick, New Jersey  
Local Institution Duncansville, Pennsylvania  
Local Institution North Charleston, South Carolina  
Local Institution Austin, Texas  
Local Institution Rome, Georgia  
Local Institution Chattanooga, Tennessee  
Local Institution Columbia, Missouri  
Local Institution Detroit, Michigan