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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 (May 2026). This Phase 1 trial studies multiple treatments including Venetoclax and Gemtuzumab for acute myeloid leukemia.

Phase 1RecruitingM.D. Anderson Cancer CenterNCT06448013Data as of May 2026

Treatment: Venetoclax · Gemtuzumab · ZiftomenibTo 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.

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Extracted eligibility criteria

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

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 →

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