A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients with FLT3/ITD AML

Principal Investigator

Rachel Cook

Study Purpose

The primary purpose of this study is to compare relapse-free survival between participants who have FLT3/ITD AML in CR1 who undergo a stem cell transplant and are randomized to receive the study drug gilteritinib or placebo, starting from after the time of engraftment for a two year period. This study also will seek to determine safety and tolerability of the study drug gilteritinib used after transplant, overall survival, and cumulative incidence of graft-versus-host disease.

Medical Condition(s)

Acute myeloid leukemia

Eligibility Criteria

- Patients must be legal adults with a diagnosis of AML with FLT3/ITD mutation.
- Participants must be in first remission prior to transplant, with bone marrow blast < 5% and no morphologic characteristics of acute leukemia in bone marrow and no evidence of extra medullary disease
- The preparatory regimen for transplant must begin within 30 days of the last bone marrow before transplant
- Any GvHD prophylaxis (prevention) regimen is acceptable
- Stem cells for transplant may be from any donor cell source
- patients must have evidence of engraftment after transplant
- patients must be registered for the study before transplant conditioning begins

Age Range

18 - 89

Healthy Volunteers Needed


Duration of Participation

24 months after start of study drug (or placebo), then 3-7 years for follow-up.

Minors Included



Knight Cancer Intake Center: (503)494-7999
Clinical Trials Information Line: (503)­494-­1080 or



Recruitment End


Compensation Provided


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