OncoMatch/Clinical Trials/NCT05360160

A Phase I-II Study Investigating the All-Oral Combination of the Menin Inhibitor SNDX-5613 With Decitabine/Cedazuridine (ASTX727) and Venetoclax in Acute Myeloid Leukemia (SAVE)

Is NCT05360160 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including SNDX-5613 and Venetoclax for acute myeloid leukemia.

Phase 1/2RecruitingM.D. Anderson Cancer CenterNCT05360160Data as of May 2026

Treatment: SNDX-5613 · Venetoclax · ASTX727 — Part 1b of this clinical research study is to find the highest tolerable dose of SNDX-5613 that can be given in combination with ASTX727 (a combination of the drugs decitabine/cedazuridine) and venetoclax for patients with acute myeloid leukemia (AML) or those with a mixed phenotype acute leukemia with a myeloid phenotype (MPAL). Part 2 of this study is to learn if the dose of study drugs found in Part 1b can help to control AML/MPAL

Check if I qualify

Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Biomarker criteria

Required: KMT2A (MLL) rearrangement

Required: NPM1 mutation

Required: NUP98 rearrangement

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: menin inhibitor

Prior treatment with a menin inhibitor

Lab requirements

Kidney function

creatinine clearance ≥ 30 mL/min unless related to disease

Liver function

direct bilirubin < 2x ULN unless due to Gilbert's disease or leukemic involvement; AST/ALT < 3x ULN unless due to leukemic involvement, then < 5x ULN

Cardiac function

baseline ejection fraction > 40%

Adequate hepatic function (direct bilirubin < 2x ULN unless increase is due to Gilbert's disease or leukemic involvement, and AST and/or ALT < 3x ULN unless considered due to leukemic involvement, in which case direct bilirubin or AST and/or ALT < 5x ULN will be considered eligible). Adequate renal function (creatinine clearance ≥ 30 mL/min) unless related to disease. Baseline ejection fraction must be > 40%.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

M D Anderson Cancer Center · Houston, Texas

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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