NCT00481247

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

An Open-Label, Randomized, Multicenter Phase III Trial of Dasatinib (SPRYCEL®) vs. Standard Dose Imatinib (400 mg) in the Treatment of Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 547 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myeloid Leukemia, Chronic

Interventions

Type	Name	Description
DRUG	Dasatinib	Tablets, oral, dasatinib 50-140 mg once daily (QD)
DRUG	Imatinib	Tablets, oral, imatinib 200-800 mg, QD

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-12-01
• Completion: 2015-12-01
• First posted: 2007-06-01
• Last updated: 2017-02-15
• Results posted: 2011-03-15

Locations

109 sites across 27 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Czechia, Denmark, France, Germany, Greece, Hungary, India, Italy, Japan, Mexico, Netherlands, Peru, Poland, Russia, Singapore, South Korea, Spain, Turkey (Türkiye)