Overview

Dasatinib (Sprycelâ„¢) in Patients With Newly Diagnosed Core Binding Factor (CBF) Acute Myeloid Leukemia (AML)

Status:
Completed
Trial end date:
2015-11-01
Target enrollment:
Participant gender:
Summary
This is a Phase Ib/IIa open-labeled multi-center trial evaluating the feasibility of dasatinib given after standard induction therapy with daunorubicin (DNR) and cytarabine (ARA-C), after consolidation therapy with high-dose cytarabine (HDAC), and as single agent in a one-year maintenance therapy in patients with newly diagnosed CBF AML. 82 patients with newly diagnosed CBF AML will be enrolled at AMLSG study centers. All AML patients will be assessed for the CBF fusion genes via the central laboratory of the AMLSG within 48 hours of diagnosis of AML, and only patients with CBF AML will be enrolled into the study.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
University of Ulm
Treatments:
Cytarabine
Dasatinib
Daunorubicin