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An Open-Label Randomized Phase III Study of Dasatinib vs. High-Dose (600 mg) Imatinib Mesylate in the Treatment of Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Are Imatinib Failures or Who Have Had a Suboptimal Response After 3-18 Months of Therapy With 400 mg Imatinib


Phase 3
18 Years
N/A
Not Enrolling
Both
Leukemia

Thank you

Trial Information

An Open-Label Randomized Phase III Study of Dasatinib vs. High-Dose (600 mg) Imatinib Mesylate in the Treatment of Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Are Imatinib Failures or Who Have Had a Suboptimal Response After 3-18 Months of Therapy With 400 mg Imatinib


Inclusion Criteria:



- Men and women ≥18 years diagnosed with Chronic Phase Philadelphia chromosome positive
(CP Ph+) CML who have failed to achieve CCyR after 3-18 months of therapy with
imatinib 400 mg

- Treatment initiation with imatinib 400 mg within 6 months of initial CML diagnosis

- Able to tolerate chronic administration of imatinib at the highest dose (400-600 mg)
the subject has received in the past

- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2

- Adequate hepatic and renal function

Exclusion Criteria:

- Eligible and willing to undergo immediate autologous/allogeneic stem cell transplant

- Previous diagnosis of accelerated/blast crisis CML

- Subjects with clonal evolution in Ph+ cells observed in ≥2 metaphases

- Previous documentation of T315I mutation

- Uncontrolled or significant cardiovascular disease

- Serious uncontrolled medical disorder/active infection

- History of significant bleeding disorder unrelated to CML

- Intolerance to imatinib ≥400 mg

- Concurrent malignancies other than CML

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Complete Cytogenetic Response (CCyR) Rate at Month 6

Outcome Time Frame:

Month 6

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:

CA180-044

NCT ID:

NCT00362466

Start Date:

April 2007

Completion Date:

June 2008

Related Keywords:

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

Name

Location

New York Medical CollegeValhalla, New York  10595
Local InstitutionChicago, Illinois  
Local InstitutionIndianapolis, Indiana  
Local InstitutionBronx, New York  
Local InstitutionCincinnati, Ohio  
Local InstitutionCorona, California  
Local InstitutionAurora, Colorado  
Local InstitutionFort Lauderdale, Florida  
Local InstitutionWichita, Kansas  
Local InstitutionDuluth, Minnesota  
Local InstitutionLincoln, Nebraska  
Local InstitutionNew Brunswick, New Jersey  
Local InstitutionWilmington, North Carolina  
Local InstitutionOklahoma City, Oklahoma  
Local InstitutionDuncansville, Pennsylvania  
Local InstitutionAustin, Texas  
New York Presbyterian HospitalNew York, New York  10021
Santee Hematology/OncologySumter, South Carolina  29150
Local InstitutionLittle Rock, Arkansas  
Local InstitutionColumbia, Missouri  
Local InstitutionLouisville, Kentucky  
M.D. Anderson Cancer Center OrlandoOrlando, Florida  32806
Local InstitutionDetroit, Michigan  
Local InstitutionLas Vegas, Nevada  
Dr. Marshall SchreederHuntsville, Alabama  35805