Actively Recruiting

Phase 1
Age: 3Years - 21Years
All Genders
NCT06448013

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

Led by M.D. Anderson Cancer Center · Updated on 2025-12-15

22

Participants Needed

1

Research Sites

303 weeks

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

K

Kura Oncology, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 3Years - 21Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 3 and 21 years
  • Karnofsky score for children over 16 years or Lansky score for children under 16 years
  • Diagnosis of relapsed or refractory AML or MPAL with a myeloid phenotype
  • Evidence of leukemia in bone marrow by morphology or molecular testing
  • Presence of specific mutations such as KMT2Ar, NUP98r, NPM1c, UBTF-ITD, or other HOX pathway mutations
  • White blood cell count below 25,000 per microliter at enrollment; cytoreduction allowed before enrollment
  • Baseline heart ejection fraction greater than 40%
  • Adequate liver function with bilirubin and liver enzymes within specified limits
  • Adequate kidney function with creatinine clearance of at least 30 mL/min unless related to disease
  • At least 14 days since prior treatment unless allowed exceptions for rapidly proliferative disease
  • At least 3 months washout after bone marrow transplantation
  • Women of childbearing potential must agree to use effective contraception during and after the study
Not Eligible

You will not qualify if you...

  • Weighing less than 10 kilograms
  • Having uncontrolled medical conditions, laboratory abnormalities, or psychiatric illnesses posing risk
  • Using other chemotherapeutic or anti-leukemic agents except specified exceptions
  • Severe gastrointestinal or metabolic conditions interfering with oral medication absorption
  • Chronic liver disease
  • Concurrent active malignancy under treatment
  • Known active hepatitis B, hepatitis C, or HIV infection
  • Pregnant or breastfeeding females
  • Active uncontrolled infection
  • Recent serious heart problems within 6 months prior to study entry
  • Prolonged corrected QT interval over 480 ms on electrocardiograms
  • Conditions or therapies that may interfere with participation or study results
  • Active central nervous system leukemia
  • Severe graft-versus-host disease except specified controlled conditions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

B

Branko Cuglievan, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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