OncoMatch/Clinical Trials/NCT06448013
A Phase I Study Investigating the Combination of the Menin Inhibitor Ziftomenib With Venetoclax and Gemtuzumab in Pediatric Patients With Acute Myeloid Leukemia
Is NCT06448013 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1 trial studies multiple treatments including Venetoclax and Gemtuzumab for acute myeloid leukemia.
Treatment: Venetoclax · Gemtuzumab · Ziftomenib — To find the recommended dose of ziftomenib in combination with gemtuzumab ozogamicin and venetoclax that can be given to pediatric participants who have relapsed or refractory AML or MPAL.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: KMT2A (MLL) rearrangement
Presence of KMT2Ar
Required: NUP98 rearrangement
Presence of NUP98r
Required: NPM1 mutation
Presence of NPM1c
Required: UBTF internal tandem duplication
Presence of UBTF-ITD
Required: HOX pathway mutation
other HOX pathway mutation
Demographics
Lab requirements
Kidney function
creatinine clearance ≥ 30 ml/min unless related to disease
Liver function
direct bilirubin < 1.5x 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
Cardiac function
baseline ejection fraction must be > 40%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- MD Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06448013 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require KMT2A?
Yes, KMT2A rearrangement is a required biomarker for enrollment.
Does this trial require NUP98?
Yes, NUP98 rearrangement is a required biomarker for enrollment.
Does this trial require NPM1?
Yes, NPM1 mutation is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 21 years or younger and at least 3 years old.
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