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 (Jun 2026). This Phase 1/2 trial studies multiple treatments including SNDX-5613 and Venetoclax for acute myeloid leukemia.
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 qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
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)
Demographics
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 →Frequently asked questions
Is NCT05360160 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior menin inhibitor disqualifies patients from enrollment.
Does this trial require KMT2A?
Yes, KMT2A rearrangement is a required biomarker for enrollment.
Does this trial require NPM1?
Yes, NPM1 mutation is a required biomarker for enrollment.
Does this trial require NUP98?
Yes, NUP98 rearrangement 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