At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 204 enrolled
Drug / intervention
Dasatinib +3 moredrug
Likely dose
Not stated in 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.
Randomized Phase III Study of Intensive Chemotherapy With or Without Dasatinib (Sprycel™) in Adult Patients With Newly Diagnosed Core-Binding Factor Acute Myeloid Leukemia (CBF-AML)
In Brief
A Phase 3 clinical trial evaluating Dasatinib, Cytarabine, and 2 other interventions for Acute Myeloid Leukemia (AML). Completed, enrolled 204 participants across 54 sites in 2 countries.
Detailed Summary
This is a randomized phase III open-label, multicenter trial evaluating standard induction therapy (daunorubicin \[DNR\] and cytarabine \[Ara-C\]) and consolidation therapy (high-dose cytarabine \[HDAC\]) with or without dasatinib in adult patients with newly diagnosed CBF-AML
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia (AML)
CountriesAustria, Germany
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 2013
Enrollment StartJul 2014
Primary CompletionFeb 2024
TodayJul 2026
First PostedDec 17, 2013
Enrollment StartJul 1, 2014
Primary CompletionFeb 1, 2024
TodayJul 2, 2026
Enrollment to primary: 9.6 yearsPosted 12.5 years ago
Interventions
Dasatinibdrug
Cytarabinedrug
Daunorubicindrug
Idarubicindrug