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Vyxeos Plus Gilteritinib for Relapsed or Refractory FLT3-Mutated AML

This study is testing a combination of two medicines, Vyxeos and Gilteritinib, for people with acute myeloid leukemia (AML) that has come back or hasn't responded to previous treatments, and has a specific gene change called a FLT3 mutation. Vyxeos is given through a vein, and Gilteritinib is a pill. The study aims to find the highest safe dose of this combination. If you achieve a complete remission (when signs of cancer disappear), you may continue with additional treatment phases. The study is planning to enroll 22 participants, but its current status is unclear.

Study design
This study is testing a combination of two drugs in 22 participants. The phase of the study is not specified.
What's involved
You will receive Vyxeos as an intravenous infusion and Gilteritinib as a daily pill during induction, re-induction, and consolidation phases. The duration of these phases is not specified.
Compensation
Not stated in the trial record.
Follow-up
The primary goal of finding the maximum tolerated dose will be measured for up to 18 months.

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NCT05024552

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
H. Lee Moffitt Cancer Center and Research Institute
~22 participants
Updated 2025-12-05 on ClinicalTrials.gov
What's tested:GilteritinibVyxeos

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Tolerated Dose (MTD)
Measured over Up to 18 months

Conditions

Acute Myeloid Leukemia With FLT3/ITD Mutation

Explore related trials

Acute Myeloid Leukemia

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Onyee Chan, MD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center

Who to contact

Jhada-Kai Hunter
[email protected]
813-745-0286
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Eastern Cooperative Oncology Group (ECOG) performance status ≤2
FLT3-ITD or FLT3-TKD mutated AML (non-M3) in 1st or greater relapse or refractory to at least one prior line of AML directed therapy
FLT3 testing must be confirmed at the time of disease relapse
Adequate organ function
Left ventricular ejection fraction (LVEF) ≥50%
Prior anthracycline exposure ≤368 mg/m2 daunorubicin (or equivalent)
Ability to take oral medication and willingness to adhere to the medication regimen
For females of reproductive potential: use of highly effective contraception including double barrier methods (condoms with spermicidal jelly or foam and diaphragm with spermicidal jelly or foam), oral, depo provera, or injectable contraceptives, intrauterine devices and tubal ligation.
For females of reproductive potential: negative serum or urine pregnancy test with a sensitivity of at least 50mIU/mL within 10 days and again within 24 hours of beginning study treatment
For males of reproductive potential: use of condoms
Breastfeeding mothers must agree to discontinue nursing
Patients who have relapsed after and allogeneic stem cell transplant must have controlled grade ≤2 GVHD. Immunosuppression with tacrolimus or sirolimus is allowed at stable or tapering doses.

Exclusion

Patients may not be receiving any other investigational agents
Patients with documented central nervous system involvement of AML
Progression of AML while on prior gilteritinib therapy
Patients must not have evidence of GI tract abnormalities that would alter the absorption of oral medications
Major surgery within two weeks of first dose of study drug. Patients must have recovered from the effects of any surgery performed greater than two weeks prior
WBC count ≥50,000 at the time study treatment begins. Use of hydroxyurea to maintain WBC \<50,000 is allowed up to the time that study treatment begins
Predicted inability to tolerate standard induction chemotherapy
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
No other malignancies in addition to AML that are currently requiring treatment with the exception of: 1) basal cell or squamous cell carcinoma or the skin; 2) carcinoma in situ of the cervix or breast; 3) a history of breast cancer that is currently being managed with adjuvant endocrine therapy
Grade ≥3 acute or chronic graft versus host disease after allogeneic stem cell transplant. No steroids for GVHD are allowed.

What this trial measures

  • Maximum Tolerated Dose (MTD)Up to 18 months

    Dose escalation will determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Vyxeos plus Gilteritinib. The MTD is the highest dose of the combination therapy that dose not cause unacceptable side effects.