First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia
Public ClinicalTrials.gov record NCT04067336. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04067336
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 263 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 12, 2019 (Actual)
- Primary completion
- Oct 16, 2028 (Estimated)
- Completion
- Oct 16, 2028 (Estimated)
- Last update posted
- May 13, 2026
2019 – 2028
United States locations
- U.S. sites
- 20
- U.S. states
- 16
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | — |
| UCLA Ronald Reagan Medical Center | Los Angeles | California | 90095 | — |
| Mayo Clinic | Jacksonville | Florida | 32224 | — |
| Robert H. Lurie Comprehensive Cancer Center of Northwestern University | Chicago | Illinois | 60611 | — |
| University of Maryland Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | 21201 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| University of Michigan Hospitals | Ann Arbor | Michigan | 48109 | — |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Hackensack University Medical Center - John Theurer Cancer Center | Hackensack | New Jersey | 07601 | — |
| Roswell Park Comprehensive Cancer Center | Buffalo | New York | 14203 | — |
| Weill Cornell Medical College - NY Presbyterian Hospital | New York | New York | 10021 | — |
| The Mount Sinai Hospital | New York | New York | 10029 | — |
| Duke Cancer Institute | Durham | North Carolina | 27710 | — |
| Oklahoma University Health - Stephenson Cancer Center | Oklahoma City | Oklahoma | 73117 | — |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| Harold C. Simmons Comprehensive Cancer Center - UT Southwestern Medical Center | Dallas | Texas | 75390 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 23 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04067336, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 13, 2026 · Synced Oct 16, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04067336 live on ClinicalTrials.gov.