Actively Recruiting
SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation
Led by Uma Borate · Updated on 2026-05-14
30
Participants Needed
4
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase I trial tests the safety, side effects, and best dose of SNDX-5613 and gilteritinib for treating patients with acute myeloid leukemia that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory) and has a mutation in the FLT3 gene along with either a mutation in the NMP1 gene or a type of mutation called a rearrangement in the MLL gene. SNDX-5613 is in a class of medications called menin inhibitors. It works by blocking the action of mutated MLL and NMP1 proteins that signal cancer cells to multiply. Gilteritinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of mutated FLT3 proteins that signal cancer cells to multiply. Giving SNDX-5613 with gilteritinib may be safe, tolerable and/or effective in treating patients with relapsed/refractory FLT3 mutated acute myeloid leukemia.
CONDITIONS
Official Title
SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before joining the study
- Age 18 years or older at time of consent
- Confirmed diagnosis of relapsed or refractory acute myeloid leukemia with FLT3 mutation (ITD or TKD subtype) and either NPM1 mutation, MLL gene rearrangement, or other mutation causing HOXA-MEIS1 overexpression
- Receiving itraconazole, ketoconazole, posaconazole, or voriconazole for antifungal protection for at least 24 hours before enrollment and during treatment
- Not suitable for immediate intensive chemotherapy based on age, health, or local guidelines
- ECOG performance status of 0, 1, or 2
- Liver enzymes (AST, ALT) no more than 3 times the upper limit of normal
- Total bilirubin no more than 1.5 times the upper limit of normal (except Gilbert syndrome)
- Estimated kidney function (eGFR) at least 60 mL/min/1.73m2
- Adequate heart function with ejection fraction of at least 50%
- Ability to communicate and follow study procedures
- Negative pregnancy test for those who can become pregnant at screening and first treatment day
- Agreement to use contraception or abstain from intercourse for those who can impregnate others during study and 90 days after
- Able to swallow study medications
- Any previous treatment side effects resolved to grade 1 or less, except grade 2 neuropathy or hair loss
- Not currently receiving certain therapies or met required waiting periods since last treatment: radiation, stem cell transplant, immunotherapy, antileukemia therapy, hematopoietic growth factors, biologics, or steroids
- Prior treatment with gilteritinib is allowed
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia
- Diagnosis of extra-medullary AML or myeloid sarcoma
- Suspected central nervous system involvement without clearance or active treatment
- History of other malignancies unless fully treated and no ongoing systemic therapy
- Known allergy or sensitivity to gilteritinib or SNDX-5613 components
- Active HIV, hepatitis B or C infection unless well controlled or cured
- QTcF interval longer than 450 msec at screening
- Serious heart rhythm problems or recent heart attack
- Uncontrolled illnesses such as unstable angina, serious arrhythmias, or advanced heart failure
- Uncontrolled infections
- Psychiatric illness preventing informed consent
- Pregnant or breastfeeding
- Conditions preventing swallowing study drugs
- Medical conditions that may affect participation or study results as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
UNC Hospitals, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 24514
Actively Recruiting
2
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
4
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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