MedTrace Logo

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

NCT05024552 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-12-05

No results posted yet for this study

Summary

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

Conditions

  • Acute Myeloid Leukemia With FLT3/ITD Mutation

Interventions

DRUG

Gilteritinib

Gilteritinib is an oral inhibitor of FLT3-ITD and FLT3-TKD. Dose cohort 1 will receive 120mg daily on days 6-19 of induction and days 4-17 of re-induction and consolidation

DRUG

Vyxeos

Vyxeos is a liposomal encapsulation of cytarabine and daunorubicin. It is given as an intravenous infusion over 90 minutes on days 1, 3 and 5 of induction and days 1 and 3 of re-induction and consolidation. The induction and reinduction dose is 44mg/m2 daunorubicin and 100mg/m2 of cytarabine with each infusion. The consolidation dose is 29mg/m2 daunorubicin and 65mg/m2 of cytarabine with each dose.

Sponsors & Collaborators

  • Jazz Pharmaceuticals

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Onyee Chan, MD · Moffitt Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-25
Primary Completion
2027-02-15
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05024552 on ClinicalTrials.gov