Phase 3
N=519
A Phase III Study of Dasatinib vs Imatinib in Patients With Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia
Myeloid Leukemia, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT00481247 ↗Enrolled (actual)
519
Serious AEs
31.0%
Results posted
Mar 2011
Primary outcome: Primary: Number of Participants With Best Confirmed Complete Cytogenetic Response (cCCyR) Within 12 Months — 204; 177 Participants — p=0.0056
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dasatinib (Drug); Imatinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Best Confirmed Complete Cytogenetic Response (cCCyR) Within 12 Months |
204; 177 | 0.0056 sig |
| SECONDARY Percentage of Participants Remaining in Confirmed Complete Cytogenetic Response (cCCyR) |
98.0; 96.9; 96.9; 95.7; 95.6; 95.7 | — |
| SECONDARY Percentage of Participants With Major Molecular Response (MMR) at Any Time |
76.4; 64.2 | — |
| SECONDARY Time to Confirmed Complete Cytogenic Response (cCCyR) Overall |
3.1; 5.8 | — |
| SECONDARY Time to Major Molecular Response (MMR) Overall |
9.3; 15.0 | — |
| SECONDARY Percentage of Participants With Progression-free Survival (PFS) |
88.9; 89.2 | — |
| SECONDARY Percentage of Participants With Overall Survival (OS) |
90.9; 89.6 | — |
Summary
The purpose of this clinical research study is to compare the confirmed complete cytogenetic response of dasatinib with that of imatinib within 12 months after randomization in patients with newly diagnosed chronic-phase Philadelphia positive chronic myeloid leukemia. The safety of this treatment will also be studied.
Eligibility Criteria
Key Inclusion Criteria
- Male or female, aged 18 years and older
- Chronic phase, Philadelphia Chromosome-positive chronic myeloid leukemia (CML)
- Eastern Cooperative Oncology Group Performance Status score of 0-2
Key Exclusion Criteria
- Pleural Effusion
- Uncontrolled cardiovascular disease
- Significant bleeding disorder unrelated to CML
- Prior treatment with interferon/imatinib/dasatinib/anti-CML systemic treatments except anagrelide/hydroxyurea
Data sourced from ClinicalTrials.gov (NCT00481247). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.