Actively Recruiting
Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2025-12-05
22
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
J
Jazz Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to comply with all study procedures and be available for the entire study duration
- ECOG performance status of 2 or less
- Diagnosis of FLT3-ITD or FLT3-TKD mutated AML (non-M3) in first or greater relapse or refractory to at least one prior AML therapy
- Confirmation of FLT3 mutation testing at time of disease relapse
- Adequate organ function
- Left ventricular ejection fraction (LVEF) of 50% or greater
- Prior anthracycline exposure of 368 mg/m2 daunorubicin or less (or equivalent)
- Ability to take oral medication and willingness to adhere to medication regimen
- For females of reproductive potential: use of highly effective contraception and negative pregnancy tests within 10 days and again within 24 hours before treatment
- For males of reproductive potential: use of condoms
- Breastfeeding mothers must agree to stop nursing
- Patients who relapsed after allogeneic stem cell transplant must have controlled grade 2 or less graft versus host disease and may use stable or tapering immunosuppression with tacrolimus or sirolimus
You will not qualify if you...
- Receiving any other investigational agents
- Documented central nervous system involvement of AML
- AML progression while previously on gilteritinib therapy
- Evidence of gastrointestinal abnormalities that affect oral drug absorption
- Major surgery within two weeks before first study drug dose (must have recovered from surgery done more than two weeks prior)
- White blood cell count over 50,000 at treatment start (hydroxyurea use allowed to control WBC below 50,000 before treatment)
- Predicted inability to tolerate standard induction chemotherapy
- Uncontrolled illness including active infections, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social issues limiting study compliance
- Other cancers requiring treatment, except certain skin cancers, carcinoma in situ of cervix or breast, or breast cancer managed with adjuvant endocrine therapy
- Grade 3 or higher acute or chronic graft versus host disease after allogeneic stem cell transplant; no steroid use for GVHD allowed
AI-Screening
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Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
J
Jhada-Kai Hunter
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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