A Phase 1/2, Multicenter, Open-label, Single Arm, Dose Escalation and Expansion Study of the Combination of Gilteritinib, Venetoclax and Azacitidine in Patients with Newly Diagnosed FLT3 Mutated Acute Myeloid Leukemia (AML) Not Eligible for Intensive

Protocol No

ASTELLAS-2215-CL-0203

Phase

I/II

Summary

This project is being done to find out if the combination therapy of gilteritinib [ASP2215], venetoclax and azacitidine is safe and effective for treatment of recently diagnosed patients with FLT3 mutated AML who are not eligible for intensive chemotherapy.

Description

A Phase 1/2, Study of Gilteritinib, Venetoclax and Azacitidine in Patients with AML

Participating Institutions

Froedtert Hospital

Status

OPEN TO ACCRUAL

A Phase 1/2, Multicenter, Open-label, Single Arm, Dose Escalation and Expansion Study of the Combination of Gilteritinib, Venetoclax and Azacitidine in Patients with Newly Diagnosed FLT3 Mutated Acute Myeloid Leukemia (AML) Not Eligible for Intensive Induction Chemotherapy