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A Randomized Multi-Center Open Label Study of BMS-354825 vs. Imatinib Mesylate (Gleevec) 800 mg/d in Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Disease That is Resistant to Imatinib at a Dose at 400 - 600 mg/d


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

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Trial Information

A Randomized Multi-Center Open Label Study of BMS-354825 vs. Imatinib Mesylate (Gleevec) 800 mg/d in Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Disease That is Resistant to Imatinib at a Dose at 400 - 600 mg/d


Inclusion Criteria:



- Men and women, 18 years of age or older.

- Subjects with Chronic Phase Ph+ CML.

- Subjects have not been treated with imatinib at a dose >600 mg/day.

- Subjects developed resistance to disease while receiving an imatinib dose 400-600
mg/day.

- Able to tolerate imatinib at the highest dose the subject had received in the past.

- Demonstrate adequate renal and hepatic function.

- Women of childbearing potential must have a negative serum or urine pregnancy test,
must be using an adequate method of contraception.

Exclusion Criteria:

- Women who are unwilling or unable to use an acceptable method to avoid pregnancy for
the entire study period for a least 1 month before and at least 3 months after the
completion of the study.

- Women using a prohibited contraceptive method.

- Women 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.

- Prior treatment with imatinib at a dose >600 mg/day.

- Subjects who have previously identified specific BCR-ABL mutations.

- Previous diagnosis of accelerated phase or blast crisis CML.

- Intolerance to imatinib at any dose.

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

- Serious uncontrolled medical disorder or active infection.

- Uncontrolled or significant cardiovascular disease.

- Uncontrolled hypertension.

- Dementia or altered mental status.

- Evidence of organ dysfunction.

- 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.

- Subjects taking certain medications that are accepted to have a risk of causing
Torsades de Pointes.

- Subjects taking medications that irreversibly inhibit platelet function or
anticoagulants.

- Prior therapy with BMS-354825.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Major Cytogenetic Response (MCyR) at Week 12

Outcome Description:

Cytogenetic response was based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample (aspirate/biopsy). MCyR was defined as Complete CyR (CCyR; 0% Ph+ cells in metaphase in bone marrow) or Partial CyR (PCyR; >0% to 35% Ph+ cells in metaphase in bone marrow).

Outcome Time Frame:

Week 12

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:

CA180-017

NCT ID:

NCT00103844

Start Date:

February 2005

Completion Date:

March 2008

Related Keywords:

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

Name

Location

Local InstitutionChicago, Illinois  
Local InstitutionIndianapolis, Indiana  
Local InstitutionPortland, Oregon  
Local InstitutionVancouver, Washington  
Local InstitutionBirmingham, Alabama  
Local InstitutionCorona, California  
Local InstitutionAurora, Colorado  
Local InstitutionHamden, Connecticut  
Local InstitutionWashington, District of Columbia  
Local InstitutionFort Lauderdale, Florida  
Local InstitutionWichita, Kansas  
Local InstitutionSpringfield, Massachusetts  
Local InstitutionDuluth, Minnesota  
Local InstitutionLincoln, Nebraska  
Local InstitutionNew Brunswick, New Jersey  
Local InstitutionWilmington, North Carolina  
Local InstitutionOklahoma City, Oklahoma  
Local InstitutionDuncansville, Pennsylvania  
Local InstitutionNorth Charleston, South Carolina  
Local InstitutionAustin, Texas  
Local InstitutionArlington, Virginia  
Local InstitutionRome, Georgia  
Local InstitutionChattanooga, Tennessee  
Local InstitutionColumbia, Missouri  
Local InstitutionLouisville, Kentucky