A Phase III Study of Dasatinib vs Imatinib in Patients With Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Dasatinib; Imatinib Mesylate

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