Recruiting

Phase 1

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

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Code:

NCT05024552

Conditions

Acute Myeloid Leukemia With FLT3/ITD Mutation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Gilteritinib

Vyxeos

Study Details

Brief 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

Study ID

NCT05024552

Start date

Feb 25, 2022

Status verified date

Dec, 2025

Completion date

Mar, 2027

Anticipated

Primary completion date

Feb 15, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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.

Study Design

Enrollment

22 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation Arm

Participants will receive intravenous Vyxeos on days 1, 3 and 5 and Gilteritinib will be given on days 6-19 of induction therapy. The induction and reinduction dose of Vyxeos is 44mg/m2 daunorubicin and 100mg/m2 of cytarabine with each infusion.

Dose level 1: Vyxeos + 120 mg Gilertinib

In the event of a dose-limiting toxicity (DLT) at the initial dose level, a dose level minus (-) 1 is permitted Dose Level -1: Vyxeos + 80 mg Gilertinib

experimental: Dose Expansion Arm

Participants will receive intravenous Vyxeos on days 1, 3 and 5 and Gilteritinib will be given on days 6-19 of induction therapy in the dose determined in the dose escalation arm.

Interventions

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

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.

Primary outcome measure

Maximum Tolerated Dose (MTD) [ Time Frame: Up to 18 months ]

Central Contacts and Locations

Central contacts

Jhada-Kai Hunter

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

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Jhada-Kai Hunter

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

Principal Investigator:

Onyee Chan, MD

More Information

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Last update posted

Dec 5, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute on 2025-12-05.