Overview

A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML)

Status:
Active, not recruiting

Trial end date:
2025-04-30

Target enrollment:

Participant gender:

Summary

The purpose of this study is to compare relapse-free survival between participants with FLT3/ITD AML in first morphologic complete remission (CR1) who undergo hematopoietic stem cell transplant (HCT) and are randomized to receive gilteritinib or placebo beginning after the time of engraftment for a two year period.

Phase:

Phase 3

Details

Lead Sponsor:

Astellas Pharma Global Development, Inc.

Collaborators:

Blood and Marrow Transplant Clinical Trials Network
National Heart, Lung, and Blood Institute (NHLBI)