Investigating Ziftomenib, Venetoclax, and Gemtuzumab for Pediatric AML

This study is looking for a safe dose of a new combination of medicines for children and young adults (ages 3-21) with acute myeloid leukemia (AML) or mixed phenotype acute leukemia (MPAL) that has come back or not responded to previous treatments. The medicines being tested are ziftomenib, venetoclax, and gemtuzumab. The main goal is to find the right dose of ziftomenib when given with venetoclax and gemtuzumab. Researchers will also look at how well this combination works to shrink the leukemia and how long patients respond to the treatment. You may be eligible if you have relapsed/refractory AML or MPAL with certain genetic changes (like KMT2Ar, NUP98r, NPM1c, UBTF-ITD, or other HOX pathway mutations). The study plans to enroll 22 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 22 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and side effects will be measured through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06448013

A Phase I Study Investigating the Combination of the Menin Inhibitor Ziftomenib With Venetoclax and Gemtuzumab in Pediatric Patients With Acute Myeloid Leukemia

Recruiting
PHASE1Ages 3–21InterventionalTreatment
M.D. Anderson Cancer Center
~22 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:VenetoclaxGemtuzumabZiftomenib

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and adverse events (AEs)
Measured over Through study completion; an average of 1 year
Acute Myeloid Leukemia
1 sites across 1 states
Texas1
  • Branko Cuglievan, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

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  • Safety and adverse events (AEs)Through study completion; an average of 1 year

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0