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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 College Valhalla, New York  10595
Local Institution Chicago, Illinois  
Local Institution Indianapolis, Indiana  
Local Institution Bronx, New York  
Local Institution Cincinnati, Ohio  
Local Institution Corona, California  
Local Institution Aurora, Colorado  
Local Institution Fort Lauderdale, Florida  
Local Institution Wichita, Kansas  
Local Institution Duluth, Minnesota  
Local Institution Lincoln, Nebraska  
Local Institution New Brunswick, New Jersey  
Local Institution Wilmington, North Carolina  
Local Institution Oklahoma City, Oklahoma  
Local Institution Duncansville, Pennsylvania  
Local Institution Austin, Texas  
New York Presbyterian Hospital New York, New York  10021
Santee Hematology/Oncology Sumter, South Carolina  29150
Local Institution Little Rock, Arkansas  
Local Institution Columbia, Missouri  
Local Institution Louisville, Kentucky  
M.D. Anderson Cancer Center Orlando Orlando, Florida  32806
Local Institution Detroit, Michigan  
Local Institution Las Vegas, Nevada  
Dr. Marshall Schreeder Huntsville, Alabama  35805