Status:
TERMINATED
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
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00362466
Start Date
April 1 2007
End Date
June 1 2008
Last Update
November 20 2009
Active Locations (45)
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1
Dr. Marshall Schreeder
Huntsville, Alabama, United States, 35805
2
Local Institution
Little Rock, Arkansas, United States, 72205
3
Local Institution
Alhambra, California, United States, 91801
4
Local Institution
Anaheim, California, United States, 92801