Ziftomenib + Mezigdomide for Acute Myeloid Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to evaluate the safety and tolerability of mezigdomide in combination with ziftomenib in adolescent and adult participants with either KMT2A-rearranged (KMT2A-r) or NPM1-mutant relapsed or refractory acute myeloid leukemia (AML).
Who Is on the Research Team?
Amir Fathi, MD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
This trial is for adolescents and adults with relapsed or refractory acute myeloid leukemia (AML), specifically those with KMT2A rearrangements or NPM1 mutations. Participants must be over 12 years old, weigh at least 40 kg, have an ECOG performance status of 0-2, and meet certain health criteria including normal liver function tests and a cardiac LVEF of ≥40%.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ziftomenib and mezigdomide orally once daily for 12 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Mezigdomide
- Ziftomenib
Trial Overview
The study is testing the safety and effectiveness of combining two drugs: Ziftomenib and Mezigdomide. It targets patients whose AML has specific genetic changes (KMT2A-r or NPM1-mutant) that have not responded to previous treatments.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Ziftomenib will be taken orally once daily of each cycle. A drug diary will be provided to participants to document information about taking ziftomenib. Mezigdomide will be taken orally once daily on days 1-21 or possibly days 1-14 of each cycle. The study doctor will confirm which days mezigdomide will be taken on. A drug diary will be provided to participants to document information about taking mezigdomide.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Kura Oncology, Inc.
Industry Sponsor
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania
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