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

• Status: Terminated
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

Criteria

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