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Revumenib in Combination With Azacitidine + Venetoclax in Patients NPM1-mutated or KMT2A-rearranged AML

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint added 1 → 2 primary endpoints
See other at-risk trials from Stichting Hemato-Oncologie voor Volwassenen Nederland

Record History

  1. Study sites: 203 to 201v8
  2. Site details revised at 3 of 203 sitesv7
  3. Study sites: 201 to 203v6
  4. Primary endpoint(s) modified Start date: Mar 31, 2025 to May 5, 2025 · Trial sites expanded: 67 → 201 locations · Completion pushed from Jul 10, 2031 to Aug 27, 2032 · 4 morev5 Show 7 more changesShow less
    • Start date: Mar 31, 2025 to May 5, 2025
    • Trial sites expanded: 67 → 201 locations
    • Completion pushed from Jul 10, 2031 to Aug 27, 2032
    • Enrollment target: 415 to 448
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: 7 to 9
    • Collaborators: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  5. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Mar 10, 2025 to Mar 31, 2025 · Site details revised at 67 of 67 sitesv4 Show 2 more changesShow less
    • Start date changed from estimate of Mar 10, 2025 to Mar 31, 2025
    • Site details revised at 67 of 67 sites
Show 2 earlier versionsHide 2 earlier versions
  1. Primary completion date: May 13, 2028 to Dec 13, 2029 Completion date: May 31, 2031 to Jul 10, 2031 · Start date: Feb 13, 2025 to Mar 10, 2025v3 Show 2 more changesShow less
    • Completion date: May 31, 2031 to Jul 10, 2031
    • Start date: Feb 13, 2025 to Mar 10, 2025
  2. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06652438
Lead Sponsor Stichting Hemato-Oncologie voor Volwassenen Nederland
Collaborators: German-Austrian Acute Myeloid Leukemia Study Group, United Kingdom AML Research Network, Beat AML, LLC
Conditions Acute Myeloid Leukemia, Adult
Enrollment 448 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov