RecruitingPhase 1NCT05024552

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

A Phase 1 Study of Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated Acute Myeloid Leukemia


Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

22 participants

Start Date

Feb 25, 2022

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of Vyxeos (a dual chemotherapy drug) and gilteritinib (a targeted drug for FLT3-mutated leukemia) in people with acute myeloid leukemia (AML) that has come back or stopped responding to prior treatment. **You may be eligible if...** - You have AML (not the M3/promyelocytic subtype) with a FLT3-ITD or FLT3-TKD mutation confirmed at the time of relapse - Your cancer has relapsed or is refractory (not responding) to at least one prior AML treatment - Your physical health score (ECOG) is 2 or below - Your heart function (ejection fraction) is at least 50% - Your prior exposure to anthracycline chemotherapy (a class of drugs) is within safe limits - Your organ function is adequate **You may NOT be eligible if...** - You do not have a confirmed FLT3 mutation - You have AML subtype M3 (acute promyelocytic leukemia) - Your heart function is below the required threshold - You have active uncontrolled infections or other significant health problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGilteritinib

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

DRUGVyxeos

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.


Locations(1)

Moffitt Cancer Center

Tampa, Florida, United States

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NCT05024552


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