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SNDX-5613 and Gilteritinib for Relapsed or Refractory FLT3-Mutated AML

This study is testing the safety and best dose of two medications, SNDX-5613 (revumenib) and gilteritinib, for people with acute myeloid leukemia (AML) that has come back (relapsed) or isn't responding to treatment (refractory). You may be eligible if your AML has a specific change in the FLT3 gene, along with a change in the MLL gene (a rearrangement) or the NPM1 gene (a mutation). SNDX-5613 works by blocking certain proteins that make cancer cells grow, and gilteritinib also blocks proteins that signal cancer cells to multiply. The main goal is to see how safe this combination of drugs is and what side effects might occur. This study plans to enroll about 30 participants, but its current recruitment status is unclear.

Study design
This is a dose-escalation study, meaning participants will start with lower doses that are gradually increased to find the safest and most effective amount. It plans to enroll 30 participants.
What's involved
You would take SNDX-5613 and gilteritinib by mouth daily in cycles. You would also have blood samples, bone marrow biopsies, and heart tests (echocardiograms) throughout the study.
Compensation
Not stated in the trial record.
Follow-up
After treatment, you would have a follow-up visit 30 days later, and then every 6 months for up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06222580

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Uma Borate
~30 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:Biospecimen CollectionBone Marrow Aspiration and BiopsyGilteritinibRevumenibEchocardiography TestMultigated Acquisition Scan

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of hematologic adverse events (AEs)
Measured over Up to 30 days after completion of study treatment
+2 more outcomes measured

Conditions

Acute Myeloid Leukemia With FLT3/ITD Mutation
Acute Myeloid Leukemia With KMT2A Rearrangement
Acute Myeloid Leukemia With NPM1 Mutation
Recurrent Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia

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Acute Myeloid LeukemiaHOXA-MEIS1KMT2A GeneNPM1 GeneReceptor-Type Tyrosine-Protein Kinase FLT3

Where it's being run

4 sites across 4 states
North Carolina1
Ohio1
Pennsylvania1
Wisconsin1

Study leadership

  • Uma M Borate, MD, MS · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center

Who to contact

The Ohio State University Comprehensive Cancer Center
[email protected]
800-293-5066
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Signed informed consent must be obtained prior to participation in the study
Age ≥ 18 years at the date of signing the informed consent form (ICF)
Morphologically confirmed diagnosis of the following based on 2022 World Health Organization (WHO) classification:
Relapsed or Refractory Acute Myeloid Leukemia with the following:
Refractory disease classified as having received 2 cycles of intensive induction or 2 cycles of hypomethylating agent (HMA) + Venetoclax with persistent disease of ≥ 5% blasts in the bone marrow and/or reappearance of peripheral blasts
FLT-3 mutated disease of the ITD or TKD subtype, AND
NPM1 mutation, MLL gene rearrangement and any other mutation that has proven HOXA-MEIS1 overexpression (NUP98, UBTF-TD, MLL-PTD and any others that have supporting literature)
Patients must be receiving itraconazole, ketoconazole, posaconazole, or voriconazole (strong CYP3A4 inhibitors) for antifungal prophylaxis for at least 24 hours prior to enrollment and while on SNDX-5613 treatment. Patients must not be receiving any other strong CYP3A4 inhibitors/inducers
Not suitable for immediate myeloablative/intensive chemotherapy based on investigator assessment of age, comorbidities, local guidelines, institutional practice (any or all of these)
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN)
Total bilirubin ≤ 1.5 × ULN (except in the setting of isolated Gilbert syndrome)
Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/min/1.73m\^2 (estimation based on Modification of Diet in Renal Disease (MDRD) formula, by local laboratory)
Adequate cardiac function defined as ejection fraction (EF) of ≥50% by echocardiogram or multigated acquisition (MUGA) scan
Patient can communicate with the investigator and has the ability to comply with the requirements of the study procedures
Participants of childbearing potential must agree to have a negative serum pregnancy test at screening and a negative serum or urine pregnancy test on the first day of study treatment
Participants capable of impregnating others who are having intercourse with people of childbearing potential must agree to abstain from intercourse or have their partner use 2 forms of contraception from the screening visit until 90 days after the last dose of study treatment. They must also refrain from sperm donation from the screening visit until 90 days following the last dose of study treatment
Must be able to swallow the study medications
Any prior treatment-related toxicities resolved to ≤ grade 1 prior to enrollment, with the exception of ≤ grade 2 neuropathy or alopecia
Patients are not currently receiving the following therapies or have discontinued therapy based on the time periods below:
Radiation Therapy: At least 60 days from prior total body irradiation (TBI), craniospinal radiation and/or ≥ 50% radiation of the pelvis, or at least 14 days from local palliative radiation therapy (small port)
Stem Cell Infusion: At least 60 days must have elapsed from hematopoietic stem cell transplant (HSCT) and at least 4 weeks must have elapsed from donor lymphocyte infusion (DLI)
Immunotherapy: At least 42 days since prior immunotherapy, including tumor vaccines and checkpoint inhibitors, and at least 21 days since receipt of chimeric antigen receptor therapy or other modified T cell therapy
Antileukemia Therapy\*\*\*: At least 14 days, or 5 half-lives, whichever is shorter, since the completion of antileukemic therapy (for example, but not limited to, small molecule or cytotoxic/myelosuppressive therapy), with the following exceptions:
Wah-out can be shorter for patients with rapidly progressing disease as determined by the treating investigator
Hydroxyurea for cytoreduction can be initiated without restriction related to timing of study entry. Hydroxyurea can be continued concomitantly with SNDX-5613, with medical monitor approval. Patients may continue to receive prophylactic intrathecal chemotherapy at any time at the treating physician's discretion
Hematopoietic Growth Factors: At least 7 days since the completion of therapy with short-acting hematopoietic growth factors and 14 days with long-acting growth factors
Biologics (e.g., monoclonal antibody therapy): At least 90 days, or 5 half-lives, whichever is shorter, since the completion of therapy with an antineoplastic biologic agent
Steroids: At least 7 days since systemic glucocorticoid therapy, unless receiving physiologic dosing (equivalent to ≤10 mg prednisone daily for patients ≥ 18 years or ≤10 mg/m\^2 /day for patients
Prior treatment with gilteritinib is allowed

Exclusion

Diagnosis of acute promyelocytic leukemia
Diagnosis of extra-medullary acute myeloid leukemia (AML) based on WHO 2022 classification or myeloid sarcoma
Suspected central nervous system (CNS) involvement. Patients with history of cerebrospinal fluid (CSF) involvement must either have documented CSF clearance prior to treatment initiation or be receiving active treatment for CNS involvement
Participants with prior malignancy, except:
Participants with history of adequately treated malignancy for which no anticancer systemic therapy (namely chemotherapy, radiotherapy or surgery) is ongoing or required during the course of the study
Participants who are receiving adjuvant therapy such as hormone therapy are eligible. However, participants who developed therapy related neoplasms are not eligible
Previous known allergy/sensitivity to components of gilteritinib or SNDX-5613. Prior treatment with gilteritinib is allowed and does not exclude a patient
Patient with known human immunodeficiency virus (HIV) or has active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. For patients with evidence of chronic HBV infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Individuals with a history of HCV infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Fridericia's corrected QT interval (QTcF) \> 450 msec at time of screening
Clinically significant ventricular arrhythmia (e.g., ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
Uncontrolled intercurrent illness including, but not limited to, unstable angina pectoris, serious cardiac arrhythmia, myocardial infarction within 2 months prior to enrollment, New York Heart Association (NYHA) Class III or IV heart failure
Patients with uncontrolled infection will not be enrolled until infection is treated and under control per the principal investigator or their designee
Any psychiatric illness that prevents patient from informed consent process
Pregnant or breastfeeding at the time of enrollment
Patient has a malabsorption syndrome or other condition that precludes an enteral route of administration
Patient has history of a cardiovascular, endocrinologic, hepatic, immunologic metabolic, neurologic, psychiatric, pulmonary, renal disease, or any other condition that in the opinion of the investigator would adversely affect his/her participation in this study or interpretation of study results

What this trial measures

  • Incidence of hematologic adverse events (AEs)Up to 30 days after completion of study treatment

    Adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. The toxicity data captured will include type, frequency, grade, severity, timing of onset, duration and relationship to study drug. Frequency tables will be used to summarize the AE data, where the number of patients with different types of AE will be tabulated by toxicity grade, counting only the highest grade of a certain type of AE occurred to the same patient. All adverse events regardless of attribution as well as those treatment- related AEs will be summarized.

  • Incidence of non-hematologic adverse eventsUp to 30 days after completion of study treatment

    Adverse events will be graded according to CTCAE v5.0. The toxicity data captured will include type, frequency, grade, severity, timing of onset, duration and relationship to study drug. Frequency tables will be used to summarize the AE data, where the number of patients with different types of AE will be tabulated by toxicity grade, counting only the highest grade of a certain type of AE occurred to the same patient. All adverse events regardless of attribution as well as those treatment- related AEs will be summarized.

  • Recommended phase 2 dose for drug combinationDuring cycle 1 (28 days)

    Will be determined based on the maximum tolerated dose in conjunction with pharmacokinetic and pharmacodynamic assessments.