NCT01593254

Study of Dasatinib vs Imatinib in Patients With Chronic Myeloid Leukemia (CML) Who Did Not Have Favorable Response to Imatinib

An Open Label, Randomized (2:1) Phase IIb Study of Dasatinib Versus Imatinib in Patients With Chronic Phase Chronic Myeloid Leukemia Who Have Not Achieved an Optimal Response to 3 Months of Therapy With 400 mg Imatinib

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 262 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the hypothesis that patients with CML who have not achieved optimal response after 3 months of treatment with imatinib will have a better response by switching to dasatinib compared to staying on their original imatinib regimen.

Conditions

• Chronic Phase Chronic Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Imatinib
DRUG	Dasatinib

Timeline

• Start date: 2012-09-12
• Primary completion: 2017-11-08
• Completion: 2022-04-12
• First posted: 2012-05-08
• Last updated: 2023-06-22
• Results posted: 2019-04-11

Locations

101 sites across 15 countries: United States, Argentina, Austria, Belgium, Brazil, Canada, China, Czechia, France, Hungary, Italy, Poland, South Korea, Spain, Thailand