At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 547 enrolled
Drug / intervention
Dasatinib +1 moredrug
Likely dose
Dasatinib 140 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Dasatinib and Imatinib for Myeloid Leukemia, Chronic. Completed, enrolled 547 participants across 109 sites in 27 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyeloid Leukemia, Chronic
CountriesArgentina, 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), United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 2007
Enrollment StartSep 2007
Primary CompletionDec 2009
Study CompletionDec 2015
TodayJul 2026
First PostedJun 1, 2007
Enrollment StartSep 1, 2007
Primary CompletionDec 1, 2009
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 19.1 years ago
Interventions
Dasatinibdrug
Tablets, oral, dasatinib 50-140 mg once daily (QD)
Imatinibdrug
Tablets, oral, imatinib 200-800 mg, QD