Tests revumenib with chemotherapy for newly diagnosed acute myeloid leukemia with NPM1 mutation
Tests revumenib added to chemotherapy in people aged 12 and older with newly diagnosed AML.
Plain-language title generated from the registry record
Registry title: Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation
Key facts
- Where
- Alexandria, Bari, Bergamo, Bologna, Brescia, Candiolo, Florence, Genoa, Meldola, Milan, Modena, Monza, Naples, Palermo, Pavia, Perugia, Pesaro, Pisa, Reggio Calabria, Reggio Emilia, Rimini, Rome, Turin, and Udine, ItalySee the 28 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- How old are you?
- Has your leukemia (AML) been treated yet? Please do not count hydroxyurea (a tablet that lowers white blood cell counts) or leukapheresis (a machine that filters extra white blood cells out of your blood).
- Has your doctor said you cannot have intensive chemotherapy (very strong chemotherapy given in hospital)?
- Has a lab test of your blood or bone marrow found one of these gene changes in your leukemia?
- Are you pregnant or breastfeeding?
- How old is the patient who may join a trial?
- What type of cancer has the patient been diagnosed with?
- Is the patient pregnant or breastfeeding?
Source: NCT07211958, who can take part
Where in Italy
- Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo AlessandriaAlexandria, ItalyTaking people
- Azienda Universitaria Ospedaliera Consorziale Policlinico BariBari, ItalyTaking people
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamo, ItalyTaking people
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyTaking people
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBrescia, ItalyTaking people
- Istituto di Candiolo Fondazione del Piemonte per l'oncologia IRCCSCandiolo, ItalyTaking people
- Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyTaking people
- IRCCS Azienda Ospedaliera MetropolitanaGenoa, ItalyTaking people
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.lMeldola, ItalyTaking people
- ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyTaking people
- Istituto Europeo di Oncologia s.r.lMilan, ItalyTaking people
- Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
- Azienda Ospedaliero - Universitaria di ModenaModena, ItalyTaking people
- Fondazione IRCCS San Gerardo dei TintoriMonza, ItalyTaking people
- Azienda Ospedaliera di Rilievo Nazionale Antonio CardarelliNaples, ItalyTaking people
- La Maddalena S.p.A.Palermo, ItalyTaking people
- Fondazione IRCCS Policlinico San MatteoPavia, ItalyTaking people
- Azienda Ospedaliera di PerugiaPerugia, ItalyTaking people
- Azienda Sanitaria Territoriale di Pesaro e UrbinoPesaro, ItalyTaking people
- Azienda Ospedaliero Universitaria PisanaPisa, ItalyTaking people
- Grande Ospedale Metropolitano Bianchi Melacrino MorelliReggio Calabria, ItalyTaking people
- Azienda USL IRCCS di Reggio EmiliaReggio Emilia, ItalyTaking people
- Azienda Unita Sanitaria Locale Della RomagnaRimini, ItalyTaking people
- Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
- Ospedale Pediatrico Bambino GesùRome, ItalyTaking people
- Azienda Ospedaliera Ordine Mauriziano di TorinoTurin, ItalyTaking people
- Azienda Sanitaria Universitaria Friuli CentraleUdine, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Syndax Pharmaceuticals
- Trial code
- NCT07211958EU 2025-522279-27-00
- Record updated
- 21 October 2026
- Original description
The purpose of this study is to assess if adding revumenib to standard chemotherapy improves outcomes in participants with AML with certain genetic mutations compared to chemotherapy alone. The study will also assess the safety of adding revumenib to chemotherapy.Read full original descriptionShow less
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Revumenib in Combination With Intensive Chemotherapy in Participants With Newly Diagnosed AML With an NPM1 Mutation
The purpose of this study is to assess if adding revumenib to standard chemotherapy improves outcomes in participants with AML with certain genetic mutations compared to chemotherapy alone. The study will also assess the safety of adding revumenib to chemotherapy.
Inclusion: Participants must have newly diagnosed and previously untreated AML and be candidates for intensive chemotherapy; Presence of an NPM1 mutation; Eastern Cooperative Oncology Group performance status ≤2 (≤1 if >65 years old); Karnofsky or Lansky ≥40; Have a life expectancy of ≥3 months as judged by the Investigator; Negative serum pregnancy test; Adequate liver, kidney, and cardiac function.
Exclusion: Any gastrointestinal (GI) issue of the upper GI tract likely to affect oral drug absorption or ingestion; Any concurrent malignancy requiring active therapy (except breast or prostate cancer stable on or responding to endocrine therapy); Inability to swallow oral medication; Active central nervous system disease; Participant has known active or chronic hepatitis B or active hepatitis C (HCV) infection or human immunodeficiency virus (HIV)-positive with detectable viral load; Note: Additional inclusion/exclusion criteria may apply, per protocol; Fridericia's corrected QT interval (QTcF) >450 milliseconds at screening, diagnosis or suspicion of Long QT syndrome or family history of Long QT syndrome; Diagnosis of active acute promyelocytic leukemia; Pregnant or nursing females.