Revumenib in Combination With Azacitidine + Venetoclax in Patients NPM1-mutated or KMT2A-rearranged AML
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Nowo zdiagnozowana ostra białaczka szpikowa (AML) z mutacją genu NPM1 lub zmianą w genie KMT2A, potwierdzona w laboratorium.
- •Pacjent nie kwalifikuje się do intensywnego leczenia chemioterapią ze względu na wiek (powyżej 75 lat) lub inne choroby towarzyszące.
- •Pacjent ma co najmniej 18 lat.
- •Przewidywany czas życia pacjenta wynosi co najmniej 12 tygodni.
✗ Disqualifies
- •Pacjenci z niektórymi typami zmian w genie KMT2A (duplikacje lub delecje częściowe).
- •Pacjenci, którzy wzięli udział w innym badaniu klinicznym dotyczącym leczenia AML w określonym czasie przed rozpoczęciem tego badania.
- •Kobiety w ciąży lub karmiące piersią.
- •Pacjenci z ciężkimi chorobami innych narządów, które mogą wpływać na bezpieczeństwo leczenia.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 4, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (203)
US-Los Angeles CA-UCLA
Los Angeles, United States
US-San Francisco CA-UCSF
San Francisco, United States
US-Jacksonville FL-MAYOFL
Jacksonville, United States
US-Atlanta GA-EMORY
Atlanta, United States
US-Kansas City KS-KUMC
Fairway, United States
US-Baltimore MD-UMGCCC
Baltimore, United States
US-Rochester MN-MAYOMN
Rochester, United States
US-New York-MSKCC
New York, United States
US-Chapel Hill-UNCNORTHCAROLINA
Chapel Hill, United States
US-Cincinnati OH-CINCY
Cincinnati, United States
US-Colombus OH-OSU
Columbus, United States
US-Portland OR-OHSU
Portland, United States
US-Pittsburgh PA-PITT
Pittsburgh, United States
US-Providence RI-BROWN
Providence, United States
US-Dallas TX-SOUTHWESTERN
Dallas, United States
US-Wheeling WV-WVU
Wheeling, United States
AU-Adelaide-RAH
Adelaide, Australia
AU-Birtinya-SUNSHINECOASTUH General Information
Birtinya, Australia
AU-Brisbane-RBWH
Brisbane, Australia
AU-Douglas-TOWNSVILLE
Douglas, Australia
AU-Melbourne-ALFRED
Melbourne, Australia
AU-Melbourne-MONASH
Melbourne, Australia
AU-Perth-FSH
Perth, Australia
AU-Perth-SCGH
Perth, Australia
AU-Sydney-RNSH
Sydney, Australia
AU-Sydney-SVSH
Sydney, Australia
AT-Feldkirch-IKHF
Feldkirch, Austria
AT-Linz-KEPLER
Linz, Austria
AT-Salzburg-SALK
Salzburg, Austria
AT-Vienna-HANUSCH
Vienna, Austria
BE-Antwerpen-ZAS
Antwerp, Belgium
BE-Brugge-AZBRUGGE
Bruges, Belgium
BE-Brussel-BORDET
Brussels, Belgium
BE-Brussel-UZBRUSSEL
Brussels, Belgium
BE-Bruxelles-STLUC
Brussels, Belgium
BE-Gent-UZGENT
Ghent, Belgium
BE-Hasselt-VIRGAJESSE
Hasselt, Belgium
BE-Leuven-UZLEUVEN
Leuven, Belgium
BE-Liege-CHULIEGE
Liège, Belgium
BE-Yvoir-MONTGODINNE
Yvoir, Belgium
DK-Aalborg-AALBORGUH
Aalborg, Denmark
DK-Aarhus N-AUH
Aarhus N, Denmark
DK-Copenhagen-RIGSHOSPITALET
Copenhagen, Denmark
DK-Odense-OUH
Odense, Denmark
EE-Tallinn-REGIONAALHAIGLA
Tallinn, Estonia
EE-Tartu-TARTU
Tartu, Estonia
FI-Helsinki-HUS
Helsinki, Finland
FI-Oulu-OYS
Oulu, Finland
FI-Tampere-TAYS
Tampere, Finland
FI-Turku-TYKS
Turku, Finland
FR-Amiens-CHUAMIENS
Amiens, France
FR-Angers-CHUANGERS
Angers, France
FR-Bayonne-CHCOTEBASQUE
Bayonne, France
FR-Besançon Cedex-JEANMINJOZ
Besançon, France
FR-Caen-CHUCAEN
Caen, France
FR-Clamart-HIAPERCY
Clamart, France
FR-Clermont Ferrand-ESTAING
Clermont-Ferrand, France
FR-Créteil cedex-CHUMONDOR
Créteil, France
FR-Grenoble cedex 9-CHUGRENOBLE
Grenoble, France
FR-Le Chesnay cedex-CHVERSAILLES
Le Chesnay, France
FR-Lille-CHULILLE
Lille, France
FR-Limoges-CHULIMOGES
Limoges, France
FR-Metz-Cedex-MERCY
Metz, France
FR-Montpellier-STELOI
Montpellier, France
FR-Nantes-CHUNANTES
Nantes, France
FR-Nice-LARCHET
Nice, France
FR-Pessac Cedex-CHUBORDEAUX
Pessac, France
FR-Lyon Pierre Benite cedex-LYONSUD
Pierre-Bénite, France
FR-Rouen cedex-BECQUEREL
Rouen, France
FR-Saint-Priest-en-Jarez-STETIENNE
Saint-Priest-en-Jarez, France
FR-Strasbourg cedex-HAUTEPIERRE
Strasbourg, France
DE-Berlin-CAMPUSBENFRANKLIN
Berlin, Germany
DE-Berlin-CAMPUSVIRCHOW
Berlin, Germany
DE-Berlin-VIVANTESNEUKOLLN
Berlin, Germany
DE-Bochum-RUB
Bochum, Germany
DE-Bonn-UNIBONN
Bonn, Germany
DE-Braunschweig-KLINIKUMBRAUNSCHWEIG
Braunschweig, Germany
DE-Bremen-KBM
Bremen, Germany
DE-Darmstadt-KLINIKUMDARMSTADT
Darmstadt, Germany
DE-Essen-KEM
Essen, Germany
DE-Flensburg-MALTESER
Flensburg, Germany
DE-Freiburg-UNIKLINIKFREIBURG
Freiburg im Breisgau, Germany
DE-Greifswald-UNIGREIFSWALD
Greifswald, Germany
Halle-UMH
Halle, Germany
DE-Hamburg-ASKLEPIOSSTGEORG
Hamburg, Germany
DE-Hamburg-UKE
Hamburg, Germany
DE-Hannover-MHHANNOVER
Hanover, Germany
DE-Heilbronn-SLK General Information
Heilbronn, Germany
DE-Herne-MARIENHOSPITALHERNE
Herne, Germany
DE-Karlsruhe-KLINIKUMKARLSRUHE
Karlsruhe, Germany
DE-Magdeburg-OVGU
Magdeburg, Germany
DE-Mainz-UNIMEDIZINMAINZ
Mainz, Germany
DE-Minden-MUEHLENKREISKLINKEN
Minden, Germany
DE-München-IRZTUM
München, Germany
DE-Oldenburg-KLINIKUMOLDENBURG
Oldenburg, Germany
DE-Potsdam-BERGMANN
Potsdam, Germany
DE-Regensburg-UKR
Regensburg, Germany
DE-Rostock-MUROSTOCK
Rostock, Germany
DE-Stuttgart-KLINIKUMSTUTTGART
Stuttgart, Germany
DE-Tübingen-MEDUNITUEBINGEN
Tübingen, Germany
DE-Ulm-UNIKLINKULM
Ulm, Germany
DE-Wuppertal-HELIOSGESUNDHEIT
Wuppertal, Germany
IE-Cork-CUH
Cork, Ireland
IE-Dublin 4-SVUH
Dublin, Ireland
IE-Dublin 7-MATER
Dublin, Ireland
IE-Dublin 8-STJAMES
Dublin, Ireland
IE-Dublin 9-BEAUMONT
Dublin, Ireland
IE-Galway-UHGALWAY
Galway, Ireland
IE-Waterford City-WATERFORD
Waterford, Ireland
IT-Ancona-MARCHE
Ancona, Italy
IT-Bologna-MALPHIGI
Bologna, Italy
IT-Civitanova Marche-AZURZONA
Civitanova Marche, Italy
IT-Milano-NIGUARDA
Milan, Italy
IT-Pagani-TORTORA
Pagani, Italy
IT-Palermo-CERVELLO
Palermo, Italy
IT-Perugia-OSPEDALEPERUGIA
Perugia, Italy
IT-Pescara-AUSLPESCARA
Pescara, Italy
IT-Roma-SAPIENZA
Roma, Italy
IT-Roma-TORVERGATA
Roma, Italy
IT-Torino-CITTADELLASALUTE
Torino, Italy
IT-Trieste-MAGGIORETRIESTE
Trieste, Italy
LT-Vilnius-SANTA
Vilnius, Lithuania
NL-Den Bosch-JBZ
's-Hertogenbosch, Netherlands
NL-Amersfoort-MEANDERMC
Amersfoort, Netherlands
Amsterdamumc
Amsterdam, Netherlands
NL-Amsterdam-OLVG
Amsterdam, Netherlands
NL-Arnhem-RIJNSTATE
Arnhem, Netherlands
NL-Breda-AMPHIA
Breda, Netherlands
NL-Delft-RDGG
Delft, Netherlands
NL-Dordrecht-ASZ
Dordrecht, Netherlands
NL-Dordrecht-ASZ
Dordrecht, Netherlands
NL-Eindhoven-MAXIMAMC
Eindhoven, Netherlands
NL-Enschede-MST
Enschede, Netherlands
NL-Goes-ADRZ
Goes, Netherlands
NL-Groningen-UMCG
Groningen, Netherlands
NL-Leeuwarden-FRISIUSMC
Leeuwarden, Netherlands
NL-Leiden-LUMC
Leiden, Netherlands
NL-Maastricht-MUMC
Maastricht, Netherlands
NL-Nieuwegein-ANTONIUS
Nieuwegein, Netherlands
NL-Nijmegen-RADBOUDUMC
Nijmegen, Netherlands
NL-Rotterdam-ERASMUSMC
Rotterdam, Netherlands
NL-Den Haag-HAGA
The Hague, Netherlands
NL-Utrecht-UMCUTRECHT
Utrecht, Netherlands
NL-Zwolle-ISALA
Zwolle, Netherlands
NO-Bergen-HELSEBERGEN
Bergen, Norway
NO-Drammen-VESTREVIKEN
Drammen, Norway
NO-Lørenskog-AKERSHUS
Lørenskog, Norway
NO-Oslo-OSLOUH
Oslo, Norway
NO-Stavanger-HELSESTAVANGER
Stavanger, Norway
NO-Tromsø-NORTHNOORWEGEN
Tromsø, Norway
NO-Trondheim-STOLAV
Trondheim, Norway
ES-Alicante-BALMIS
Alicante, Spain
ES-Barcelona-CLINICUB
Barcelona, Spain
ES-Barcelona-GERMANTRIALS
Barcelona, Spain
ES-Barcelona-ICODURANREYNALS
Barcelona, Spain
ES-Barcelona-MUTUATERRASSA
Barcelona, Spain
ES-Barcelona-PARCDESALUTMAR
Barcelona, Spain
ES-Barcelona-SANTPAU
Barcelona, Spain
ES-Girona-ICOGIRONA
Girona, Spain
ES-Lleida-ICSVILANOVA
Lleida, Spain
ES-Madrid-CSGREGORIOMARANON
Madrid, Spain
ES-Palma-SSIB
Palma de Mallorca, Spain
ES-Tarragona-JOAN
Tarragona, Spain
ES-Valencia-MALVARROSA
Valencia, Spain
SE-Goteborg-SAHLGRENSKA
Gothenburg, Sweden
SE-Lund-SUH
Lund, Sweden
SE-Stockholm-KAROLINSKAHUDDINGE
Stockholm, Sweden
SE-Uppsala-UPPSALAUH
Uppsala, Sweden
CH-Aarau-KSA
Aarau, Switzerland
CH-Basel-USB
Basel, Switzerland
CH-Bellinzona-IOSI
Bellinzona, Switzerland
CH-Bern-INSEL
Bern, Switzerland
CH-Geneve (14)-HCUGE
Geneva, Switzerland
CH-Zürich-USZ
Zurich, Switzerland
Belfasttrust
Belfast, United Kingdom
Birmingham-QE
Birmingham, United Kingdom
Blackpool Victoria
Blackpool, United Kingdom
UK-Bodelwyddan-BCUHB
Bodelwyddan, United Kingdom
UK-Bristol-BRISTOLCENTRE
Bristol, United Kingdom
University Hospital of Wales
Cardiff, United Kingdom
UK-Portsmouth-QUEENALEXANDRA
Cosham, United Kingdom
UK-Coventry-UHCOVENTRYANDWARWICKSHIRE
Coventry, United Kingdom
UK-Derby-ROYALDERBYHOSPITAL
Derby, United Kingdom
UK-Edinburgh-WGH
Edinburgh, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
UK-Harrow-NORTHWICK
Harrow, United Kingdom
UK-Hull-CASTLEHILL
Hull, United Kingdom
St. James UH
Leeds, United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom
King's College Hospital
London, United Kingdom
St Bartholomew's Hospital
London, United Kingdom
University College Hospital
London, United Kingdom
Christie NHS Foundation Trust
Manchester, United Kingdom
UK-Manchester-ROYALINFIRMARY
Manchester, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Churchill Hospital, Oxford
Oxford, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
UK-Stoke on Trent-UHNM
Stoke-on-Trent, United Kingdom
The Royal Marsden NHSFT
Sutton, United Kingdom
UK-Swindon-GWH
Swindon, United Kingdom
UK-Cornwall-RCH
Truro, United Kingdom
New cross hospital wolverhampton
Wolverhampton, United Kingdom
Trial contact
Gerwin Huls, MD
Paresh Vyas, MD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/31/2026.
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