OncoMatch/Clinical Trials/NCT06222580
SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation
Is NCT06222580 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including Gilteritinib and Revumenib for acute myeloid leukemia with flt3/itd mutation.
Treatment: Gilteritinib · Revumenib — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: FLT3 ITD
FLT-3 mutated disease of the ITD or TKD subtype
Required: FLT3 TKD
FLT-3 mutated disease of the ITD or TKD subtype
Required: NPM1 mutation
NPM1 mutation
Required: KMT2A (MLL) rearrangement
MLL gene rearrangement
Allowed: NUP98 mutation with proven HOXA-MEIS1 overexpression
any other mutation that has proven HOXA-MEIS1 overexpression (NUP98, UBTF-TD, MLL-PTD and any others that have supporting literature)
Allowed: UBTF tandem duplication with proven HOXA-MEIS1 overexpression
any other mutation that has proven HOXA-MEIS1 overexpression (NUP98, UBTF-TD, MLL-PTD and any others that have supporting literature)
Allowed: KMT2A (MLL) partial tandem duplication with proven HOXA-MEIS1 overexpression
any other mutation that has proven HOXA-MEIS1 overexpression (NUP98, UBTF-TD, MLL-PTD and any others that have supporting literature)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: intensive induction
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
Must have received: hypomethylating agent + Venetoclax (Venetoclax)
2 cycles of hypomethylating agent (HMA) + Venetoclax with persistent disease of ≥ 5% blasts in the bone marrow and/or reappearance of peripheral blasts
Lab requirements
Kidney function
Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/min/1.73m^2 (MDRD formula, by local laboratory)
Liver function
AST and ALT ≤ 3 × upper limit of normal (ULN); Total bilirubin ≤ 1.5 × ULN (except in the setting of isolated Gilbert syndrome)
Cardiac function
Ejection fraction (EF) of ≥50% by echocardiogram or MUGA scan
AST and 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 (MDRD formula, by local laboratory); Adequate cardiac function defined as ejection fraction (EF) of ≥50% by echocardiogram or multigated acquisition (MUGA) scan
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UNC Hospitals, University of North Carolina at Chapel Hill · Chapel Hill, North Carolina
- Ohio State University Comprehensive Cancer Center · Columbus, Ohio
- University of Pennsylvania · Philadelphia, Pennsylvania
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06222580 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received intensive induction and hypomethylating agent + Venetoclax.
Does this trial require FLT3?
Yes, FLT3 ITD is a required biomarker for enrollment.
Does this trial require FLT3?
Yes, FLT3 TKD is a required biomarker for enrollment.
Does this trial require NPM1?
Yes, NPM1 mutation is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify