A Study of Ivosidenib or Enasidenib in Combination With Induction Therapy and Consolidation Therapy, Followed by Maintenance Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myedysplastic Syndrome EB2, With an IDH1 or IDH2 Mutation, Respectively, Eligible for Intensive Chemotherapy

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

968

Participants

Timeline

Start Date

March 1, 2019

Primary Completion Date

April 17, 2027

Study Completion Date

September 19, 2034

Conditions
Acute Myeloid LeukemiaMyelodysplastic Syndrome With Excess Blasts-2
Interventions
DRUG

AG-120

250mg tablets

DRUG

Placebo for AG-120

250mg tablets

DRUG

AG-221

100mg tablets

DRUG

Placebo for AG-221

100mg tablets

Trial Locations (181)

Unknown

AU-Adelaide-FLINDERS, Adelaide

AU-Adelaide-RAH, Adelaide

AU-Brisbane-PAH, Brisbane

AU-Camperdown-RPA, Camperdown

AU-Canberra-CANBERRAHOSPITAL, Canberra

AU-Douglas-TOWNSVILLE, Douglas

AU-Hobart TAS-RHOBART, Hobart

AU-Launceston TAS-LAUNCESTON, Launceston

AU-Melbourne-ALFRED, Melbourne

AU-Melbourne-AUSTIN, Melbourne

AU-Melbourne-MONASH, Melbourne

AU-Melbourne-RMELBOURNE, Melbourne

AU-Melbourne-SVHM, Melbourne

AU-Perth-FSH, Perth

AU-Perth-RPH, Perth

AU-Perth-SCGH, Perth

AU-Sydney-CONCORD, Sydney

AU-Sydney-RNSH, Sydney

AU-Sydney-SVHS, Sydney

AU-Sydney-WSAH, Sydney

AU-Waratah-CALVARYMATER, Waratah

AT-Graz-MEDUNIGRAZ, Graz

AT-Innsbruck-IMED, Innsbruck

AT-Linz-ORDENSKLINIKUM, Linz

AT-Vienna-HANUSCH, Vienna

BE-Antwerpen-ZNASTUIVENBERG, Antwerp

BE-Brugge-AZBRUGGE, Bruges

BE-Brussel-BORDET, Brussels

BE-Brussel-UZBRUSSEL, Brussels

BE-Bruxelles-STLUC, Brussels

BE-Gent-UZGENT, Ghent

BE-Haine-Saint-Paul-JOLIMONT, Haine-Saint-Paul

BE-Hasselt-VIRGAJESSE, Hasselt

BE-Leuven-UZLEUVEN, Leuven

BE-Liege-CHRCITADELLE, Liège

BE-Liege-CHULIEGE, Liège

BE-Roeselare-AZDELTA, Roeselare

BE-Yvoir-MONTGODINNE, Yvoir

EE-Tartu-TARTU, Tartu

FI-Helsinki-HUS, Helsinki

FI-Tampere-TAYS, Tampere

FR-Amiens-CHUAMIENS, Amiens

FR-Angers-CHUANGERS, Angers

FR-Argenteuil-CHARGENTEUIL, Argenteuil

FR-Bayonne-CHCOTEBASQUE, Bayonne

FR-Besançon Cedex-JEANMINJOZ, Besançon

FR-Bobigny-AVICENNE, Bobigny

FR-Chambery-CHMETROPOLESAVOIE, Chambéry

FR-Le Chesnay cedex-CHVERSAILLES, Chesnay

FR-Clamart-HIAPERCY, Clamart

FR-Clermont-Ferrand-ESTAING, Clermont-Ferrand

FR-Créteil cedex-CHUMONDOR, Créteil

FR-Grenoble cedex 9-CHUGRENOBLE, Grenoble

FR-Lens-CHLENS, Lens

FR-Lille-CHULILLE, Lille

FR-Limoges-CHULIMOGES, Limoges

FR-Lyon Pierre Benite cedex-LYONSUD, Lyon

FR-Lyon-LEONBERARD, Lyon

FR-Marseille-IPC, Marseille

FR-Montpellier-STELOI, Montpellier

FR-Mulhouse-GHRMSA, Mulhouse

FR-Nantes-CHUNANTES, Nantes

FR-Nice-CAL, Nice

FR-Nice-LARCHET, Nice

FR-Orléans-CHORLEANS, Orléans

FR-Paris cedex 10-SAINTLOUIS, Paris

FR-Paris cedex 12-SAINTANTOINE, Paris

FR-Paris cedex 15-NECKER, Paris

FR-Pessac Cedex-CHUBORDEAUX, Pessac

FR-Poitiers-CHUPOITERS, Poitiers

FR-Reims-CHREIMS, Reims

FR-Rennes cedex 9-CHURENNES, Rennes

FR-Rouen cedex-BECQUEREL, Rouen

FR-Strasbourg cedex-HAUTEPIERRE, Strasbourg

FR-Toulouse-CHUTOULOUSE, Toulouse

FR-Tours cedex-BRETONNEAU, Tours

FR-Vandoeuvre Les Nancy-CHRUNANCY, Vandœuvre-lès-Nancy

FR-Villejuif-GUSTAVEROUSSY, Villejuif

DE-Bad Saarow-HELIOSBADSAAROW, Bad Saarow

DE-Berlin-CAMPUSBENFRANKLIN, Berlin

DE-Berlin-CAMPUSVIRCHOW, Berlin

DE-Berlin-VIVANTESNEUKOLLN, Berlin

DE-Berlin-VIVANTESURBAN, Berlin

DE-Bochum-RUB, Bochum

DE-Bonn-UNIBONN, Bonn

DE-Braunschweig-KLINIKUMBRAUNSCHWEIG, Braunschweig

DE-Bremen-KBM, Bremen

DE-Dortmund-JOHODORTMUND, Dortmund

DE-Düsseldorf-MEDUNIDUESSELDORF, Düsseldorf

DE-Essen-KEM, Essen

DE-Esslingen-KLINIKUMESSLINGEN, Esslingen am Neckar

DE-Flensburg-MALTESER, Flensburg

DE-Giessen-UKGM, Giessen

DE-Goch-KKLE, Goch

DE-Hamburg-ASKLEPIOSSTGEORG, Hamburg

DE-Hamburg-ASKLEPIOS, Hamburg

DE-Hamburg-UKE, Hamburg

DE-Hamm-EVKHAMM, Hamm

DE-Hanau-KLINIKUMHANAU, Hanau

DE-Hannover-MHHANNOVER, Hanover

DE-Hannover-SILOAHKRH, Hanover

DE-Herne-MARIENHOSPITALHERNE, Herne

DE-Homburg-UNIKLINIKSAARLAND, Homburg

DE-Karlsruhe-KLINIKUMKARLSRUHE, Karlsruhe

DE-Lebach-CARITASKHLEBACH, Lebach

DE-Lemgo-KLINIKUMLIPPE, Lemgo

DE-Ludwigshafen-KLILU, Ludwigshafen

DE-Luedenscheid-KLINIKUMLUEDENSCHEID, Lüdenscheid

DE-Magdeburg-OVGU, Magdeburg

DE-Mainz-KLINKUNIMAINZ, Mainz

DE-Mainz-UNIMEDIZINMAINZ, Mainz

DE-Meschede-HOCHSAUERLAND, Meschede

DE-Minden-MUEHLENKREISKLINKEN, Minden

DE-München-IRZTUM, München

DE-München-MEDUNIMUNCHIN, München

DE-Offenburg-ORTENAUKLINIKUM, Offenburg

DE-Oldenburg-KLINIKUMOLDENBURG, Oldenburg

DE-Passau-KLINIKUMPASSAU, Passau

DE-Stuttgart-DIAKSTUTTGART, Stuttgart

DE-Stuttgart-KLINIKUMSTUTTGART, Stuttgart

DE-Traunstein-TSSOB, Traunstein

DE-Trier-MUTTERHAUS, Trier

DE-Tübingen-MEDUNITUEBINGEN, Tübingen

DE-Ulm-UNIKLINKULM, Ulm

DE-Villingen-Schwenningen-SBKVS, Villingen-Schwenningen

DE-Wuppertal-HELIOSGESUNDHEIT, Wuppertal

IE-Cork-CUH, Cork

IE-Dublin 8-STJAMES, Dublin

IE-Dublin 9-BEAUMONT, Dublin

IE-Galway-UHGALWAY, Galway

LT-Vilnius-SANTA, Vilnius

LU-Luxembourg-CHL, Luxembourg

NL-Den Bosch-JBZ, 's-Hertogenbosch

NL-Amersfoort-MEANDERMC, Amersfoort

NL-Amsterdam-AMC, Amsterdam

NL-Amsterdam-OLVG, Amsterdam

NL-Amsterdam-VUMC, Amsterdam

NL-Arnhem-RIJNSTATE, Arnhem

NL-Breda-AMPHIA, Breda

NL-Delft-RDGG, Delft

NL-Dordrecht-ASZ, Dordrecht

NL-Eindhoven-MAXIMAMC, Eindhoven

NL-Enschede-MST, Enschede

NL-Groningen-UMCG, Groningen

NL-Leeuwarden-MCL, Leeuwarden

NL-Leiden-LUMC, Leiden

NL-Maastricht-MUMC, Maastricht

NL-Nieuwegein-ANTONIUS, Nieuwegein

NL-Nijmegen-RADBOUDUMC, Nijmegen

NL-Rotterdam-ErasmusMC, Rotterdam

NL-Den Haag-HAGA, The Hague

NL-Utrecht-UMCUTRECHT, Utrecht

NL-Zwolle-ISALA, Zwolle

NO-Bergen-HELSEBERGEN, Bergen

NO-Oslo-OSLOUH, Oslo

NO-Stavanger-HELSESTAVANGER, Stavanger

NO-Tromsø-NORTHNOORWEGEN, Tromsø

NO-Trondheim-STOLAV, Trondheim

ES-Barcelona-CLINICUB, Barcelona

ES-Barcelona-GERMANTRIALS, Barcelona

ES-Barcelona-ICODURANREYNALS, Barcelona

ES-Barcelona-MUTUATERRASSA, Barcelona

ES-Barcelona-PARCDESALUTMAR, Barcelona

ES-Barcelona-SANTPAU, Barcelona

ES-Barcelona-VHEBRON, Barcelona

ES-Girona-ICSTRUETA, Girona

ES-Madrid-CSGREGORIOMARANON, Madrid

ES-Palma-SSIB, Palma

ES-Tarragona-JOAN, Tarragona

ES-Valencia-MALVARROSA, Valencia

SE-Lund-SUH, Lund

SE-Stockholm-KAROLINSKAHUDDINGE, Stockholm

SE-Uppsala-UPPSALAUH, Uppsala

CH-Basel-USB, Basel

CH-Bellinzona-IOSI, Bellinzona

CH-Bern-INSEL, Bern

CH-Fribourg-HFR, Fribourg

CH-Geneve (14)-HCUGE, Geneva

CH-Luzern-LUKS, Lucerne

CH-St. Gallen-KSSG, Sankt Gallen

CH-Zürich-USZ, Zurich

All Listed Sponsors
collaborator

Deutsch-Österreichische Studiengruppe Akute Myeloische Leukämie (AMLSG)

UNKNOWN

lead

Stichting Hemato-Oncologie voor Volwassenen Nederland

OTHER