Acute Myeloid Leukemia (AML) Clinical Trial
Official title:
Open-Label, Multicenter Phase Ib/IIa Study For the Evaluation of Dasatinib (Sprycel™) Following Induction and Consolida-tion Therapy as Well as in Maintenance Therapy in Patients With Newly Diagnosed Core Binding Factor (CBF) Acute Myeloid Leukemia (AML)
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.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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