A Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive Chemotherapy

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

777

Participants

Timeline

Start Date

December 20, 2019

Primary Completion Date

October 31, 2025

Study Completion Date

June 30, 2033

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

Gilteritinib

Patients with a FLT3 mutation w ill be randomized to receive either the investigational drug gilteritinib or midostaurin given sequentially to standard induction and consolidation chemotherapy. After completing induction and consolidation treatment, patients who achieve CR/CRi/MLFS will receive maintenance therapy with gilteritinib or midostaurin

DRUG

Midostaurin

Patients with a FLT3 mutation w ill be randomized to receive either the investigational drug gilteritinib or midostaurin given sequentially to standard induction and consolidation chemotherapy. After completing induction and consolidation treatment, patients who achieve CR/CRi/MLFS will receive maintenance therapy with gilteritinib or midostaurin

Trial Locations (193)

Unknown

AU-Adelaide-FLINDERS, Adelaide

AU-Adelaide-RAH, Adelaide

AU-Brisbane-PAH, Brisbane

AU-Brisbane-RBWH, Brisbane

AU-Camperdown-RPA, Camperdown

AU-Douglas-TOWNSVILLE, Douglas

AU-Geelong VIC-BARWONHEALTH, Geelong

AU-Gosford NSW-GOSFORDHOSPITAL, Gosford

AU-Hobart TAS-RHOBART, Hobart

AU-Melbourne-ALFRED, Melbourne

AU-Melbourne-AUSTIN, Melbourne

AU-Melbourne-BOXHILL, 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-NEPEAN, Sydney

AU-Sydney-RNSH, Sydney

AU-Sydney-WSAH, Sydney

St George Hospital, Sydney

AU-Waratah-CALVARYMATER, Waratah

AT-Graz-MEDUNIGRAZ, Graz

AT-Innsbruck-IMED, Innsbruck

AT-Linz-KEPLER, Linz

AT-Linz-ORDENSKLINIKUM, Linz

AT-Salzburg-SALK, Salzburg

AT-Vienna-HANUSCH, Vienna

BE-Antwerpen-ZNASTUIVENBERG, Antwerp

BE-Brugge-AZBRUGGE, Bruges

BE-Brussel-BORDET, 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-Mons-AMBROISE, Mons

BE-Roeselare-AZDELTA, Roeselare

BE-Yvoir-MONTGODINNE, Yvoir

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-Le Chesnay cedex-CHVERSAILLES, Chesnay

FR-Clamart-HIAPERCY, Clamart

FR-Clermont-Ferrand-ESTAING, Clermont-Ferrand

FR-Grenoble cedex 9-CHUGRENOBLE, Grenoble

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-Nantes-CHUNANTES, Nantes

FR-Nice-CAL, Nice

FR-Nice-LARCHET, Nice

FR-Paris cedex 10-SAINTLOUIS, 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-Saint-Priest-en-Jarez-ICLOIRE, Saint-Priest-en-Jarez

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-Aschaffenburg-KLINIKUMAB, Aschaffenburg

DE-Bad Saarow-HELIOSBADSAAROW, Bad Saarow

DE-Berlin-CAMPUSBENFRANKLIN, Berlin

DE-Berlin-CAMPUSMITTE, 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-Darmstadt-KLINIKUMDARMSTADT, Darmstadt

DE-Dortmund-JOHODORTMUND, Dortmund

DE-Düsseldorf-MEDUNIDUESSELDORF, Düsseldorf

DE-Essen-KEM, Essen

DE-Esslingen-KLINIKUMESSLINGEN, Esslingen am Neckar

DE-Flensburg-MALTESER, Flensburg

DE-Frankfurt-KLINIKUMFRANKFURT, Frankfurt

DE-Giessen-UKGM, Giessen

DE-Goch-KKLE, Goch

DE-Greifswald-UNIGREIFSWALD, Greifswald

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-Heilbronn-SLK, Heilbronn

DE-Herne-MARIENHOSPITALHERNE, Herne

DE-Homburg-UNIKLINIKSAARLAND, Homburg

DE-Kaiserslautern-WESTPFALZ, Kaiserslautern

DE-Karlsruhe-KLINIKUMKARLSRUHE, Karlsruhe

DE-Lemgo-KLINIKUMLIPPE, Lemgo

DE-Ludwigshafen-KLILU, Ludwigshafen

DE-Lübeck-UKSHLUBECK, Lübeck

DE-Luedenscheid-KLINIKUMLUEDENSCHEID, Lüdenscheid

DE-Magdeburg-OVGU, Magdeburg

DE-Mainz-UNIMEDIZINMAINZ, Mainz

DE-Meschede-HOCHSAUERLAND, Meschede

DE-Minden-MUEHLENKREISKLINKEN, Minden

DE-München-IRZTUM, München

DE-Offenburg-ORTENAUKLINIKUM, Offenburg

DE-Oldenburg-KLINIKUMOLDENBURG, Oldenburg

DE-Passau-KLINIKUMPASSAU, Passau

DE-Regensburg-UKR, Regensburg

DE-Saarbrücken-CARITASKLINIKUM, Saarbrücken

DE-Stuttgart-DIAKSTUTTGART, Stuttgart

DE-Stuttgart-KLINIKUMSTUTTGART, Stuttgart

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 24-TUH, Dublin

IE-Dublin 4-SVUH, Dublin

IE-Dublin 7-MATER, Dublin

IE-Dublin 8-STJAMES, Dublin

IE-Dublin 9-BEAUMONT, Dublin

IE-Galway-UHGALWAY, Galway

IE-Co. Limerick-UHL, Limerick

LT-Vilnius-SANTA, Vilnius

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-Lleida-ICSVILANOVA, Lleida

ES-Madrid-CSGREGORIOMARANON, Madrid

ES-Palma-HSLL, Palma

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-Aarau-KSA, Aarau

CH-Basel-USB, Basel

CH-Bellinzona-IOSI, Bellinzona

CH-Bern-INSEL, Bern

CH-Fribourg-HFR, Fribourg

CH-Geneve (14)-HCUGE, Geneva

CH-Lausanne-CHUV, Lausanne

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

collaborator

Astellas Pharma Global Development, Inc.

INDUSTRY

lead

Stichting Hemato-Oncologie voor Volwassenen Nederland

OTHER