Ivosidenib and Azacitidine With or Without Venetoclax in Adult Patients With Newly Diagnosed IDH1-Mutated AML or MDS/AML Considered Ineligible for Intensive Chemotherapy

PHASE3RecruitingINTERVENTIONAL
Enrollment

227

Participants

Timeline

Start Date

August 5, 2025

Primary Completion Date

December 31, 2028

Study Completion Date

March 31, 2029

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

Venetoclax 400

day 1-28 per cycle

DRUG

Placebo

day 1-28 per cycle

Trial Locations (119)

Unknown

NOT_YET_RECRUITING

AT-Feldkirch-IKHF, Feldkirch

NOT_YET_RECRUITING

AT-Salzburg-SALK, Salzburg

NOT_YET_RECRUITING

AT-Vienna-HANUSCH, Vienna

NOT_YET_RECRUITING

BE-Antwerpen-ZAS, Antwerp

NOT_YET_RECRUITING

BE-Brussel-BORDET, Brussels

NOT_YET_RECRUITING

BE-Brussel-UZBRUSSEL, Brussels

NOT_YET_RECRUITING

BE-Bruxelles-STLUC, Brussels

NOT_YET_RECRUITING

BE-Gent-UZGENT, Ghent

NOT_YET_RECRUITING

BE-Leuven-UZLEUVEN, Leuven

NOT_YET_RECRUITING

BE-Liege-CHULIEGE, Liège

RECRUITING

BE-Yvoir-MONTGODINNE, Yvoir

NOT_YET_RECRUITING

DK-Aalborg-AALBORGUH, Aalborg

NOT_YET_RECRUITING

DK-Aarhus N-AUH, Aarhus N

NOT_YET_RECRUITING

DK-Copenhagen-RIGSHOSPITALET, Copenhagen

NOT_YET_RECRUITING

DK-Odense-OUH, Odense

NOT_YET_RECRUITING

DK-Roskilde-ROSKILDE, Roskilde

NOT_YET_RECRUITING

EE-Tallinn-REGIONAALHAIGLA, Tallinn

NOT_YET_RECRUITING

EE-Tartu-TARTU, Tartu

NOT_YET_RECRUITING

FI-Helsinki-HUS, Helsinki

NOT_YET_RECRUITING

FI-Tampere-TAYS, Tampere

NOT_YET_RECRUITING

FR-Angers-CHUANGERS, Angers

NOT_YET_RECRUITING

FR-Pessac Cedex-CHUBORDEAUX, Bordeaux

NOT_YET_RECRUITING

FR-Caen-CHUCAEN, Caen

NOT_YET_RECRUITING

FR-Créteil cedex-CHUMONDOR, Créteil

NOT_YET_RECRUITING

FR-Grenoble cedex 9-CHUGRENOBLE, Grenoble

NOT_YET_RECRUITING

FR-Lille-CHULILLE, Lille

NOT_YET_RECRUITING

FR-Lyon Pierre Benite cedex-LYONSUD, Lyon

NOT_YET_RECRUITING

FR-Montpellier-CHUSAINTELOIS, Montpellier

NOT_YET_RECRUITING

FR-Nantes-CHUNANTES, Nantes

NOT_YET_RECRUITING

FR-Nice-LARCHET, Nice

NOT_YET_RECRUITING

FR-Rennes cedex 9-CHURENNES, Rennes

NOT_YET_RECRUITING

FR-Rouen cedex-BECQUEREL, Rouen

NOT_YET_RECRUITING

FR-Saint-Priest-en-Jarez-STETIENNE, Saint-Etienne

NOT_YET_RECRUITING

FR-Le Chesnay cedex-CHVERSAILLES, Versailles

NOT_YET_RECRUITING

DE-Berlin-CAMPUSBENFRANKLIN, Berlin

NOT_YET_RECRUITING

DE-Berlin-CAMPUSVIRCHOW, Berlin

NOT_YET_RECRUITING

DE-Berlin-VIVANTESNEUKOLLN, Berlin

NOT_YET_RECRUITING

DE-Bochum-RUB, Bochum

NOT_YET_RECRUITING

DE-Bonn-UNIBONN, Bonn

NOT_YET_RECRUITING

DE-Braunschweig-KLINIKUMBRAUNSCHWEIG, Braunschweig

NOT_YET_RECRUITING

DE-Bremen-KBM, Bremen

NOT_YET_RECRUITING

DE-Darmstadt-KLINIKUMDARMSTADT, Darmstadt

NOT_YET_RECRUITING

DE-Flensburg-MALTESER, Flensburg

NOT_YET_RECRUITING

DE-Freiburg-UNIKLINIKFREIBURG, Freiburg im Breisgau

NOT_YET_RECRUITING

DE-Greifswald-UNIGREIFSWALD, Greifswald

NOT_YET_RECRUITING

DE-Halle-UMH, Halle

NOT_YET_RECRUITING

DE-Hamburg-ASKLEPIOSSTGEORG, Hamburg

NOT_YET_RECRUITING

DE-Hamburg-UKE, Hamburg

NOT_YET_RECRUITING

DE-Hannover-MHHANNOVER, Hanover

NOT_YET_RECRUITING

DE-Hannover-SILOAHKRH, Hanover

NOT_YET_RECRUITING

DE-Heilbronn-SLK, Heilbronn

NOT_YET_RECRUITING

DE-Karlsruhe-KLINIKUMKARLSRUHE, Karlsruhe

NOT_YET_RECRUITING

DE-Mainz-UNIMEDIZINMAINZ, Mainz

NOT_YET_RECRUITING

DE-Minden-MUEHLENKREISKLINKEN, Minden

NOT_YET_RECRUITING

DE-München-IRZTUM, München

NOT_YET_RECRUITING

DE-Oldenburg-KLINIKUMOLDENBURG, Oldenburg

NOT_YET_RECRUITING

DE-Regensburg-UKR, Regensburg

NOT_YET_RECRUITING

DE-Stuttgart-KLINIKUMSTUTTGART, Stuttgart

NOT_YET_RECRUITING

DE-Tübingen-MEDUNITUEBINGEN, Tübingen

NOT_YET_RECRUITING

DE-Ulm-UNIKLINKULM, Ulm

NOT_YET_RECRUITING

IE-Cork-CUH, Cork

NOT_YET_RECRUITING

IE-Dublin 7-MATER, Dublin

NOT_YET_RECRUITING

IE-Dublin 8-ST JAMES, Dublin

NOT_YET_RECRUITING

IE-Galway-UHGALWAY, Galway

NOT_YET_RECRUITING

IT-Bologna-MALPHIGI, Bologna

NOT_YET_RECRUITING

IT-Milano-NIGUARDA, Milan

NOT_YET_RECRUITING

IT-Roma-SAPIENZA, Roma

NOT_YET_RECRUITING

IT-Roma-TORVERGATA, Roma

NOT_YET_RECRUITING

IT-Torino-CITTADELLASALUTE, Torino

NOT_YET_RECRUITING

LT-Vilnius-SANTA, Vilnius

NOT_YET_RECRUITING

NL-Den Bosch-JBZ, 's-Hertogenbosch

NOT_YET_RECRUITING

NL-Amsterdam-VUMC, Amsterdam

NOT_YET_RECRUITING

NL-Arnhem-RIJNSTATE, Arnhem

NOT_YET_RECRUITING

NL-Breda-AMPHIA, Breda

NOT_YET_RECRUITING

NL-Dordrecht-ASZ, Dordrecht

NOT_YET_RECRUITING

NL-Eindhoven-CATHARINA, Eindhoven

NOT_YET_RECRUITING

NL-Enschede-MST, Enschede

NOT_YET_RECRUITING

NL-Sittard-Geleen-ZUYDERLAND, Geleen

RECRUITING

NL-Groningen-UMCG, Groningen

NOT_YET_RECRUITING

NL-Nijmegen-RADBOUDUMC, Nijmegen

NOT_YET_RECRUITING

NL-Rotterdam-ERASMUSMC, Rotterdam

NOT_YET_RECRUITING

NL-DenHaag-HAGA, The Hague

NOT_YET_RECRUITING

NL-Utrecht-UMCU, Utrecht

NOT_YET_RECRUITING

NL-Zwolle-ISALA, Zwolle

NOT_YET_RECRUITING

NO-Bergen-HELSEBERGEN, Bergen

NOT_YET_RECRUITING

NO-Oslo-OSLOUH, Oslo

NOT_YET_RECRUITING

NO-Tromsø-NORTHNOORWEGEN, Tromsø

NOT_YET_RECRUITING

NO-Trondheim-STOLAV, Trondheim

NOT_YET_RECRUITING

ES-Barcelona-CLINICUB, Barcelona

NOT_YET_RECRUITING

ES-Barcelona-GERMANTRIALS, Barcelona

NOT_YET_RECRUITING

ES-Barcelona-SANTPAU, Barcelona

NOT_YET_RECRUITING

ES-Girona-ICSTRUETA, Girona

NOT_YET_RECRUITING

ES-Valencia-MALVARROSA, Valencia

NOT_YET_RECRUITING

SE-Goteborg-SAHLGRENSKA, Gothenburg

NOT_YET_RECRUITING

SE-Lund-SUH, Lund

NOT_YET_RECRUITING

SE-Stockholm-KAROLINSKAHUDDINGE, Stockholm

NOT_YET_RECRUITING

SE-Uppsala-UPPSALAUH, Uppsala

NOT_YET_RECRUITING

CH-Basel-USB, Basel

NOT_YET_RECRUITING

CH-Bellinzona-IOSI, Bellinzona

NOT_YET_RECRUITING

CH-Bern-INSEL, Bern

NOT_YET_RECRUITING

CH-Zurich-USZ, Zurich

NOT_YET_RECRUITING

UK-Birmingham-QE, Birmingham

NOT_YET_RECRUITING

UK-Blackpool-BLACKPOOLVICTORIA, Blackpool

NOT_YET_RECRUITING

UK-Bristol-BRISTOLCENTRE, Bristol

NOT_YET_RECRUITING

UK-Cardiff-UHW, Cardiff

NOT_YET_RECRUITING

UK-Glasgow-BEATSON, Glasgow

NOT_YET_RECRUITING

UK-Leeds-STJAMESUH, Leeds

NOT_YET_RECRUITING

UK-Leicester-LEICESTERRI, Leicester

NOT_YET_RECRUITING

UK-London-KCH, London

NOT_YET_RECRUITING

UK-London-ROYALMARSDEN, London

NOT_YET_RECRUITING

UK-London-UNICOLLEGEHOSP, London

NOT_YET_RECRUITING

UK-Manchester-CHRISTIE, Manchester

NOT_YET_RECRUITING

UK-Manchester-ROYALINFIRMARY, Manchester

NOT_YET_RECRUITING

UK-Newcastle on Tyne-FREEMAN, Newcastle upon Tyne

NOT_YET_RECRUITING

UK-Nottingham-NOTTINGHAMCH, Nottingham

NOT_YET_RECRUITING

UK-Oxford-CHURCHILL, Oxford

NOT_YET_RECRUITING

UK-Portsmouth-QUEENALEXANDRA, Portsmouth

NOT_YET_RECRUITING

UK-Southampton-SOUTHAMPTONGH, Southampton

NOT_YET_RECRUITING

UK-Wolverhampton-NEWCROSSH, Wolverhampton

All Listed Sponsors
collaborator

German-Austrian Acute Myeloid Leukemia Study Group

UNKNOWN

collaborator

United Kingdom AML Research Network

UNKNOWN

collaborator

Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA)

UNKNOWN

collaborator

Swiss Group for Clinical Cancer Research (SAKK)

UNKNOWN

collaborator

Danish Acute Leukemia Group

UNKNOWN

collaborator

Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias

OTHER

collaborator

Nordic AML Group

UNKNOWN

lead

Stichting Hemato-Oncologie voor Volwassenen Nederland

OTHER