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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Myeloid Leukemia, Chronic

Treatments: Drug: Imatinib; Drug: Dasatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00481247

CA180-056

2006-005712-27 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 547 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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547 participants in 2 patient groups

Dasatinib

Experimental group

Treatment:

Drug: Dasatinib

Imatinib

Active Comparator group

Treatment:

Drug: Imatinib