Study Stopped
Insufficient Enrollment
A Study of Dasatinib vs. High-Dose Imatinib (600 mg) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML) Who Failed to Achieve Complete Cytogenetic Response After 3-18 Months of Imatinib Therapy
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
1 other identifier
interventional
3
1 country
45
Brief Summary
The purpose of this clinical research study is to compare the rate of complete cytogenetic response of dasatinib to imatinib therapy at 6 months after randomization in chronic phase CML patients. The safety of this treatment will also be studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 leukemia
Started Apr 2007
Shorter than P25 for phase_3 leukemia
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2006
CompletedFirst Posted
Study publicly available on registry
August 10, 2006
CompletedStudy Start
First participant enrolled
April 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
September 3, 2009
CompletedNovember 20, 2009
November 1, 2009
1.2 years
August 9, 2006
July 24, 2009
November 18, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete Cytogenetic Response (CCyR) Rate at Month 6
Cytogenetic Response (CyR) is based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample. The criteria for CCyR is 0% Ph+ metaphases among cells in a bone marrow sample.
Month 6
Secondary Outcomes (7)
Major Molecular Response (MMR) Rates
Month 3, Month 6, Month 12, Month 24 and Month 36
CCyR Rates
Month 3, Month 12, Month 24 and Month 36
Estimate Time to MMR and CCyR
throughout the study
Progression Free Survival (PFS)
at 36 months
Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs
From 2 weeks prior to randomization through Month 36. At least every 4 weeks until all study-related toxicities resolve to baseline, stabilize, or are deemed irreversible.
- +2 more secondary outcomes
Study Arms (2)
A
ACTIVE COMPARATOR50-180 mg once daily (QD)
B
ACTIVE COMPARATOR200-800 mg QD
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
Dr. Marshall Schreeder
Huntsville, Alabama, 35805, United States
Local Institution
Little Rock, Arkansas, 72205, United States
Local Institution
Alhambra, California, 91801, United States
Local Institution
Anaheim, California, 92801, United States
Local Institution
Beverly Hills, California, 90211, United States
Local Institution
Fullerton, California, 92835, United States
Local Institution
La Jolla, California, 92093, United States
Local Institution
La Verne, California, 91750, United States
Local Institution
Long Beach, California, 90813, United States
Local Institution
Los Angeles, California, 90033, United States
Local Institution
Los Angeles, California, 90048, United States
Local Institution
Los Angeles, California, 90095, United States
Local Institution
Northridge, California, 91325, United States
Local Institution
Oxnard, California, 93030, United States
Local Institution
Redondo Beach, California, 90277, United States
Local Institution
San Francisco, California, 94143, United States
Local Institution
Santa Maria, California, 93454, United States
Local Institution
Stanford, California, 94305, United States
Local Institution
Aurora, Colorado, 80045, United States
Local Institution
Jacksonville, Florida, 32207, United States
Local Institution
Jacksonville, Florida, 32209, United States
M.D. Anderson Cancer Center Orlando
Orlando, Florida, 32806, United States
Local Institution
Pembroke Pines, Florida, 33028, United States
Local Institution
Chicago, Illinois, 60637, United States
Local Institution
Indianapolis, Indiana, 46202, United States
Local Institution
Kansas City, Kansas, 66160, United States
Local Institution
Hazard, Kentucky, 41701, United States
Local Institution
Ann Arbor, Michigan, 48109, United States
Local Institution
Rochester, Minnesota, 55905, United States
Local Institution
St Louis, Missouri, 63110, United States
Local Institution
Omaha, Nebraska, 68114, United States
Local Institution
Las Vegas, Nevada, 89135, United States
Local Institution
Hackensack, New Jersey, 07601, United States
Local Institution
Buffalo, New York, 14263, United States
New York Presbyterian Hospital
New York, New York, 10021, United States
New York Medical College
Valhalla, New York, 10595, United States
Local Institution
Durham, North Carolina, 27710, United States
Local Institution
Cleveland, Ohio, 44195, United States
Local Institution
Oklahoma City, Oklahoma, 73112, United States
Local Institution
Tulsa, Oklahoma, 74136, United States
Local Institution
Baltimore, Pennsylvania, 21229, United States
Local Institution
Pittsburgh, Pennsylvania, 15232, United States
Santee Hematology/Oncology
Sumter, South Carolina, 29150, United States
Local Institution
Dallas, Texas, 75390, United States
Local Institution
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Study was terminated early due to insufficient enrollment.
Results Point of Contact
- Title
- BMS Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 9, 2006
First Posted
August 10, 2006
Study Start
April 1, 2007
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
November 20, 2009
Results First Posted
September 3, 2009
Record last verified: 2009-11