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

NCT06448013 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-12-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Venetoclax

Given by PO

DRUG

Gemtuzumab

Given by IV

DRUG

Ziftomenib

Given by PO

Sponsors & Collaborators

  • Kura Oncology, Inc.

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Branko Cuglievan, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-07
Primary Completion
2028-12-31
Completion
2030-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06448013 on ClinicalTrials.gov