NCT00362466TerminatedPhase 3
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
Bristol-Myers Squibb6 sites in 1 country3 target enrollmentStarted: April 2007Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Enrollment
- 3
- Locations
- 6
- Primary Endpoint
- Complete Cytogenetic Response (CCyR) Rate at Month 6
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
A
Active Comparator
50-180 mg once daily (QD)
Intervention: Dasatinib (Drug)
B
Active Comparator
200-800 mg QD
Intervention: Imatinib (Drug)
Outcomes
Primary Outcomes
Complete Cytogenetic Response (CCyR) Rate at Month 6
Time Frame: 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.
Secondary Outcomes
- 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.)
- Duration of CCyR and MMR(Throughout the study)
- Best MMR Rates(throughout study)
Investigators
Study Sites (6)
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