First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia (NCT04067336)
A Phase 1/2 First in Human Study of the Menin-MLL(KMT2A) Inhibitor KO-539 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
🩺 Plain-English Summary (8th-Grade Level)
In this trial, ziftomenib, a menin-MLL(KMT2A) inhibitor, will be tested in patients for the first time. The trial includes a Main Study and four sub-studies. In the Main Study (including Phase 1a, Phase 1b, and Phase 2 portions), ziftomenib will be evaluated in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML). The main study has completed enrollment. In Sub-studies 1 and 2, the effects of taking ziftomenib and other common drugs at the same time will be investigated in AML patients. In Sub-study 3, ziftomenib will be evaluated in patients with R/R acute lymphoblastic leukemia (ALL). In Sub-study 4, ziftomenib will be evaluated in patients with R/R AML with certain genetic mutations.
Who can join: Review the eligibility criteria below.
Location: Banner MD Anderson Cancer Center — Gilbert, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (43 Sites)
Showing the first 25 of 43 sites.
- Banner MD Anderson Cancer Center — Gilbert, Arizona
- UCLA Ronald Reagan Medical Center — Los Angeles, California
- Mayo Clinic — Jacksonville, Florida
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University — Chicago, Illinois
- University of Maryland Greenebaum Comprehensive Cancer Center — Baltimore, Maryland
- Massachusetts General Hospital — Boston, Massachusetts
- University of Michigan Hospitals — Ann Arbor, Michigan
- Karmanos Cancer Institute — Detroit, Michigan
- Mayo Clinic — Rochester, Minnesota
- Hackensack University Medical Center - John Theurer Cancer Center — Hackensack, New Jersey
- Roswell Park Comprehensive Cancer Center — Buffalo, New York
- Weill Cornell Medical College - NY Presbyterian Hospital — New York, New York
- The Mount Sinai Hospital — New York, New York
- Duke Cancer Institute — Durham, North Carolina
- Oklahoma University Health - Stephenson Cancer Center — Oklahoma City, Oklahoma
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania
- Vanderbilt-Ingram Cancer Center — Nashville, Tennessee
- Harold C. Simmons Comprehensive Cancer Center - UT Southwestern Medical Center — Dallas, Texas
- MD Anderson Cancer Center — Houston, Texas
- Fred Hutchinson Cancer Research Center — Seattle, Washington
- AZ Delta - Campus Rumbeke — Roeselare,
- Queen Elizabeth II Health Sciences Centre — Halifax, Nova Scotia
- Hopital Maisonneuve-Rosemont — Montreal, Quebec
- Hopital de l'Enfant-Jesus - Centre Integre en Cancerologie du CHU de Quebec - Universite Laval — Québec, Quebec
- Centre Hospitalier Universitaire de Lille — Lille,
📞 Contact the Study Coordinator
Phone: (877) 632-6789
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.