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)

Registration Inclusion Criteria

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).

consent form (ICF).

and/or the DNA derived from that sample, if available, that may be used to validate a

companion diagnostic that is being developed in parallel with gilteritinib.

characteristics of acute leukemia (e.g., Auer Rods) in the BM with no evidence of

extramedullary disease such as central nervous system involvement or granulocytic

sarcoma.

CR1. The induction cycles can be the same regimen or different regimens. The regimen(s) may contain conventional agents, investigational agents, or a combination of both.

determined by the local institution at diagnosis.

then glomerular filtration rate (GFR) > 40 mL/min/1.73m2 as calculated with the Cockcroft-Gault equation with adjustment if total body weight is ≥ 125% of ideal body weight.

Randomization Inclusion Criteria

purposes of randomization, CR1 will be defined as < 5% blasts with no morphologic

characteristics of acute leukemia (e.g., Auer Rods) in the BM with no evidence of

extramedullary disease such as central nervous system involvement or granulocytic

sarcoma.

then GFR > 40 mL/min/1.73m2 as calculated with the Cockcroft-Gault

equation with adjustment if total body weight is ≥ 125% of ideal body weight.

must be met to be randomized:

week of randomization

addition of new agent / modality within 2 weeks of randomization. (Note that increasing calcineurin

inhibitors or sirolimus to achieve therapeutic trough levels is allowed.) Topical skin and topical gastrointestinal steroids are allowed.

Registration Exclusion Criteria

assay. Participants who have acquired immunity from past exposure (HBcAb positive / HBsAb positive / HBsAg negative) are eligible.

new symptoms, worsening physical signs or radiographic findings attributable to

infection.

participation in this clinical study.

basal cell or squamous cell carcinoma of skin or treated cervical carcinoma in situ.

Cancer treated with curative intent ≥ 5 years previously will be allowed. Cancer treated

with curative intent < 5 years previously will not be allowed.

Randomization Exclusion Criteria

CYP3A within 14 days of starting study drug.

5HT2BR or sigma nonspecific receptor with the exception of drugs that are considered

by the investigator to be absolutely essential for the care of the participant and for which

no acceptable alternative exists.

is present, the participant must be receiving definitive therapy and have no signs of

progressing infection for 72 hours prior to randomization. If a fungal infection is present,

the participant must be receiving definitive systemic anti-fungal therapy and have no

signs of progressing infection for 1 week prior to randomization.

new symptoms, worsening physical signs or radiographic findings attributable to

infection.

progressing infection.