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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

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)

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 III
Mol. targeted/Immunotherapy/Biologics
Blinded Drug
Byrne, Michael
Vanderbilt University


Not Available
Not Available
Inclusion Criteria:

Participant is considered a suitable candidate for HCT and has an acceptable source of allogeneic donor stem cells, as defined per institutional practice (allogeneic HCT for any donor source [matched sibling, unrelated donor (URD), mismatched URD, related haploidentical, or umbilical cord blood] and any graft source [umbilical cord, BM, peripheral blood (PB)], and any conditioning [myeloablative conditioning (MAC), reduced intensity conditioning (RIC), or non-myeloablative conditioning (NMA)] will be permitted).

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