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 (May 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
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
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