Ziftomenib + Quizartinib for Acute Myeloid Leukemia

Recruiting in Palo Alto (17 mi)

Overseen byGhayas Issa, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

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%).

Research Team

Ghayas Issa, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

Adults with Acute Myeloid Leukemia (AML) or related conditions, who haven't responded to previous treatments. They must have certain blood counts, organ functions within set limits, and no major heart issues in the past 6 months. Participants need to be able to take pills and agree to use contraception if they can have children.

Inclusion Criteria

I am 18 years old or older.

My white blood cell count is below 25,000/μL.

Baseline ejection fraction must be > 40%

See 8 more

Exclusion Criteria

I am not on chemotherapy, except for specific allowed treatments.

I have been treated with a menin inhibitor before.

I have an active hepatitis B, hepatitis C, or HIV infection.

See 12 more

Treatment Details

Interventions

Quizartinib (Kinase Inhibitor)
Ziftomenib (Kinase Inhibitor)

Trial OverviewThe trial is testing a combination of two oral drugs, Ziftomenib and Quizartinib, for AML treatment. It aims to provide an effective therapy option for about 40-45% of AML subtypes that share specific genetic changes.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Ziftoenib + Quizartinib Q4WExperimental Treatment2 Interventions

Participants will be randomized to study