RecruitingPhase 1

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

United States22 participantsStarted 2022-02-25

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * Patients may n…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maximum Tolerated Dose (MTD)

Timeframe: Up to 18 months

Trial details

NCT IDNCT05024552

SponsorH. Lee Moffitt Cancer Center and Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02-15

Contact for this trial

Jhada-Kai Hunter

813-745-0286 Jhada-Kai.Hunter@moffitt.org

View on ClinicalTrials.gov More Acute Myeloid Leukemia With FLT3/ITD Mutation trials