ClinicaliQ Trial Snapshot
- Revumenib in Combination With Azacitidine + Venetoclax in Patients NPM1-mutated or KMT2A-rearranged AML — Recruiting • Phase III • Oncology • NCT06652438.
- What is being tested: Revumenib (a menin inhibitor) combined with azacitidine and venetoclax in patients with newly diagnosed acute myeloid leukaemia (AML) harbouring NPM1 mutations or KMT2A rearrangements, compared to standard azacitidine-venetoclax therapy alone.
- Patient eligibility overview: Adults with newly diagnosed AML who are ineligible for intensive chemotherapy, stratified by molecular subtype (NPM1-mutated or KMT2A-rearranged disease), regardless of age or comorbidity status preventing standard intensive treatment.
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- Quick orientation before opening the registry record.
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What This Trial Is Studying
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,…
Eligibility Snapshot
- : In order to be eligible to participate in this study, a patient must meet all of the following criteria:
- Patient with newly diagnosed NPM1-mutated AML, consistent with NPM1c, according to the 2022 International Consensus Classification (i.e. ≥ 10% blasts). OR Patient with newly diagnosed KMT2A-rearranged AML according to the 2022 International Consensus Classification (i.e. ≥ 10% blasts). KMT2A partial tandem duplications or deletions are NOT eligible. Of note: in case both NPM1 and IDH1 are mutated and both EVOLVE-1 (HO173) and EVOLVE-2 (HO177) are open for inclusion at your site, then patients can only be included in the EVOLVE-1 trial (HO173) 2. Central confirmation of NPM1 mutation or KMT2A rearrangement in one of the dedicated central genetic laboratories. 3. Age ≥ 18 years, no upper age limit.
- Patient is ineligible for intensive induction chemotherapy by meeting at least 1 of the following criteria: * ≥ 75 years of age: ineligible for intensive chemotherapy per physician's discretion (with an ECOG performance status 0-2) . * 18-74 years: patient is not eligible for standard chemotherapy because any of the following co-morbidities: * ECOG performance status 2 or 3 . * Cardiac history of chronic heart failure requiring treatment;…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.