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Clinical trialNCT05024552RecruitingPhase 1Interventional

Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML

SponsorH. Lee Moffitt Cancer Center and Research InstituteEnrollment22Acute Myeloid Leukemia With FLT3/ITD Mutation
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This study combines vyxeos and gilteritinib in patients with relapsed or refractory FLT3-mutated acute myeloid leukemia. Vyxeos and gilteritinib will be given as induction therapy. Those patients entering a complete remission or a complete remission with incomplete blood count recovery will be allowed to proceed to consolidation therapy with vyxeos and gilteritinib. Those patients who do not proceed to an allogeneic stem cell transplant for any reason are able to enter the maintenance phase of this trial using daily gilteritinib
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Moffitt Cancer Center

    Tampa, Florida, United States

    Andrew T Kuykendall, MDBrandon Blue, MDDavid A Sallman, MDEric Padron, MDJeffrey E Lancet, MDOnyee Chan, MDTimothy Kubal, MD, MBA
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Gilteritinib →Cytarabine / daunorubicin →
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
25 Feb 2022
Primary completion
15 Feb 2027
Completion
31 Mar 2027
Last update posted
5 Dec 2025
Registered enrollment
22
Registry id
NCT05024552
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.