Revumenib in Combination With Azacitidine + Venetoclax in Patients NPM1-mutated or KMT2A-rearranged AML
Public ClinicalTrials.gov record NCT06652438. 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
Randomized Study to Assess Revumenib in Combination With Azacitidine + Venetoclax in Adult Patients With Newly Diagnosed NPM1-mutated or KMT2A-rearranged AML Ineligible for Intensive Chemotherapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Treatment of patients with newly diagnosed AML who are not eligible for intensive chemotherapy has remained an area of high unmet medical need. The combination therapy with two medicines, azacitidine and venetoclax, is the usual plan of action. This has brought significant progress in the treatment, but it nevertheless is not curative and the disease does relapse over time. Revumenib blocks a specific molecule called menin in the cell nucleus. Some types of AML are reliant on menin working properly. These are leukemia cells with a change in the DNA, i.e. a mutation in the NPM1 or KMT2A gene. Revumenib can prevent the production of these types of leukemia cells by disrupting the production of this menin. The current study investigates whether adding revumenib to the combination therapy improves the prognosis for AML patients with a mutation in the NPM1 or KMT2A gene. This is a randomized, double-blind, placebo-controlled clinical study where subjects will be treated until disease progression, or development of side effects or death. From the moment of inclusion of the last patient, there will be a 4-year observational follow-up study in order to register survival duration and follow-up visits. Approximately 448 previously untreated patients with a mutation in the NPM1 or KMT2A gene and with newly diagnosed AML, who are not eligible for intensive chemotherapy. Patients must be ≥18 years of age.
Study identification
- NCT ID
- NCT06652438
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 448 participants
Conditions and interventions
Conditions
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
- May 4, 2025
- Primary completion
- Dec 12, 2029
- Completion
- Aug 26, 2032
- Last update posted
- Sep 1, 2026
2025 – 2032
United States locations
- U.S. sites
- 14
- U.S. states
- 12
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| US-Los Angeles CA-UCLA | Los Angeles | California | 90095 | Not yet recruiting |
| US-San Francisco CA-UCSF | San Francisco | California | 94143 | Not yet recruiting |
| US-Jacksonville FL-MAYOFL | Jacksonville | Florida | 32224 | Not yet recruiting |
| US-Atlanta GA-EMORY | Atlanta | Georgia | 30322 | Recruiting |
| US-Kansas City KS-KUMC | Fairway | Kansas | 66205 | Not yet recruiting |
| US-Baltimore MD-UMGCCC | Baltimore | Maryland | 21201 | Recruiting |
| US-Rochester MN-MAYOMN | Rochester | Minnesota | 55905 | Not yet recruiting |
| US-Chapel Hill-UNCNORTHCAROLINA | Chapel Hill | North Carolina | 27514 | Recruiting |
| US-Cincinnati OH-CINCY | Cincinnati | Ohio | 45219 | Recruiting |
| US-Colombus OH-OSU | Columbus | Ohio | 43210 | Recruiting |
| US-Portland OR-OHSU | Portland | Oregon | 97239 | Not yet recruiting |
| US-Pittsburgh PA-PITT | Pittsburgh | Pennsylvania | 15232 | Recruiting |
| US-Dallas TX-SOUTHWESTERN | Dallas | Texas | 75390 | Not yet recruiting |
| US-Wheeling WV-WVU | Wheeling | West Virginia | 26003 | Recruiting |
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 186 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06652438, 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 Sep 1, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06652438 live on ClinicalTrials.gov.