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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 InstitutionChicago, Illinois  
Local InstitutionIndianapolis, Indiana  
Local InstitutionBaltimore, Maryland  
Local InstitutionBronx, New York  
Local InstitutionPortland, Oregon  
Local InstitutionVancouver, Washington  
Local InstitutionCorona, California  
Local InstitutionHamden, Connecticut  
Local InstitutionWashington, District of Columbia  
Local InstitutionFort Lauderdale, Florida  
Local InstitutionWichita, Kansas  
Local InstitutionSpringfield, Massachusetts  
Local InstitutionLincoln, Nebraska  
Local InstitutionNew Brunswick, New Jersey  
Local InstitutionDuncansville, Pennsylvania  
Local InstitutionNorth Charleston, South Carolina  
Local InstitutionAustin, Texas  
Local InstitutionRome, Georgia  
Local InstitutionChattanooga, Tennessee  
Local InstitutionColumbia, Missouri  
Local InstitutionDetroit, Michigan