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Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT05024552•H. Lee Moffitt Cancer Center and Research Institute

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+4 more criteria

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.

Locations (1)

Moffitt Cancer Center

Tampa, Florida, United States

Key Dates

Start Date

February 25, 2022

Primary Completion Date

February 15, 2027

Completion Date

March 1, 2027

Last Updated

December 5, 2025

Enrollment

ESTIMATED participants

Conditions

Acute Myeloid Leukemia With FLT3/ITD Mutation

Interventions

Gilteritinib

DRUG

Vyxeos

DRUG

Contacts

Jhada-Kai Hunter

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation

Venetoclax and Quizartinib in Treating Patients With FLT3-mutated Recurrent or Refractory Acute Myeloid Leukemia

The Gut Microbiome and Sorafenib Maintenance Therapy in FLT3-ITD Positive AML After Allo-HSCT

Midostaurin and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia and FLT3 Mutation