Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06769490

Dose Escalation and Expansion of Ziftomenib in Combination With Quizartinib in Acute Myeloid Leukemia

Led by M.D. Anderson Cancer Center · Updated on 2026-02-11

44

Participants Needed

1

Research Sites

270 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this all-oral combination is to deliver safe and effective therapy for the largest portion of AML subtypes (NPM1mt, KMT2Ar, NUP98r \~ 40-45%).

CONDITIONS

Official Title

Dose Escalation and Expansion of Ziftomenib in Combination With Quizartinib in Acute Myeloid Leukemia

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • ECOG performance status less than 2
  • Relapsed or refractory AML or myeloid mixed-phenotype acute leukemia with NPM1mt, KMT2Ar, or NUP98r
  • White blood cell count below 25,000/µL at enrollment (cytoreduction allowed before enrollment)
  • Baseline ejection fraction greater than 40%
  • Adequate liver function with specified bilirubin and enzyme limits
  • Adequate kidney function with estimated glomerular filtration rate above 50 mL/min unless related to disease
  • Able to swallow pills
  • Willing and able to provide informed consent
  • At least 14 days since prior treatment for non-rapidly proliferative disease, or use of hydroxyurea/cytarabine allowed for rapidly proliferative disease
  • Concurrent therapy for CNS prophylaxis or controlled CNS disease permitted
  • Women of childbearing potential and males must agree to contraception during and after the study
Not Eligible

You will not qualify if you...

  • Prior treatment with a menin inhibitor
  • Use of other chemotherapeutic or anti-leukemic agents during study except specified exceptions
  • Severe gastrointestinal or metabolic conditions interfering with oral medication absorption
  • Active malignancy under treatment besides AML
  • Known active hepatitis B, hepatitis C, or HIV infection
  • Pregnant or breastfeeding females
  • Active uncontrolled infection
  • Certain recent serious cardiovascular events or conditions within 6 months
  • History of sustained bradycardia below 50 beats per minute without pacemaker
  • Diagnosis or suspicion of congenital long QT syndrome
  • Uncontrolled hypertension despite treatment
  • QTc over 450 msec using Fridericia Formula
  • Conditions or treatments interfering with study participation or safety
  • Clinically active CNS leukemia
  • Moderate to severe active graft-versus-host disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

Loading map...

Research Team

G

Ghayas Issa, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here