Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: A Phase 3, Multicenter, Open-label, Randomized, 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 (AML) or Myelodysplastic Syndromes With Excess Blasts-2 (MDS-EB2) With FLT3 Mutations Eligible for Intensive Chemotherapy (HOVON 156 AML / AMLSG 28-18)
Study ID: NCT04027309
Study Description
Brief Summary: Activating mutations in the fms like tyrosine kinase 3 (FLT3) gene are observed in approximately 30% of patients with newly diagnosed acute myeloid leukemia (AML). Addition of the multitargeted kinase inhibitor midostaurin to standard chemotherapy prolongs event-free survival (EFS) and overall survival (OS) in patients with a FLT3 mutation. Gilteritinib is a more potent and more specific inhibitor of mutant FLT3 in comparison to midostaurin and has shown promising clinical activity in AML.
Detailed Description: AML and MDS-EB2 are malignant diseases of the bone marrow. The standard treatment for these diseases is chemotherapy. A subgroup of these diseases is characterized by a specific error in the DNA of the leukemic cells. This is the FLT3 mutation, which leads to a change of a certain protein (FLT3) on the blasts. This altered protein plays an important role in the development of leukemia and the survival of leukemic cells. FLT3 can be inhibited by the drug midostaurin. Adding midostaurin to chemotherapy leads to better treatment results in patients with AML. Therefore, the standard treatment for AML or MDS-EB2 with a FLT3 mutation (FLT3-AML) is a combination of chemotherapy and midostaurin. Gilteritinib is also a drug that inhibits FLT3. In laboratory studies, gilteritinib was found to be significantly more specific and potent than midostaurin in inhibiting FLT3. Gilteritinib has subsequently been studied in patients with AML, who relapsed after previous treatment with chemotherapy. This resulted in a much larger number of complete remissions than previously seen when comparable patients were treated with midostaurin.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
AU-Adelaide-FLINDERS, Adelaide, , Australia
AU-Adelaide-RAH, Adelaide, , Australia
AU-Brisbane-PAH, Brisbane, , Australia
AU-Brisbane-RBWH, Brisbane, , Australia
AU-Camperdown-RPA, Camperdown, , Australia
AU-Douglas-TOWNSVILLE, Douglas, , Australia
AU-Geelong VIC-BARWONHEALTH, Geelong, , Australia
AU-Gosford NSW-GOSFORDHOSPITAL, Gosford, , Australia
AU-Hobart TAS-RHOBART, Hobart, , Australia
AU-Melbourne-ALFRED, Melbourne, , Australia
AU-Melbourne-AUSTIN, Melbourne, , Australia
AU-Melbourne-BOXHILL, Melbourne, , Australia
AU-Melbourne-MONASH, Melbourne, , Australia
AU-Melbourne-RMELBOURNE, Melbourne, , Australia
AU-Melbourne-SVHM, Melbourne, , Australia
AU-Perth-FSH, Perth, , Australia
AU-Perth-RPH, Perth, , Australia
AU-Perth-SCGH, Perth, , Australia
AU-Sydney-CONCORD, Sydney, , Australia
AU-Sydney-NEPEAN, Sydney, , Australia
AU-Sydney-RNSH, Sydney, , Australia
AU-Sydney-WSAH, Sydney, , Australia
St George Hospital, Sydney, , Australia
AU-Waratah-CALVARYMATER, Waratah, , Australia
AT-Graz-MEDUNIGRAZ, Graz, , Austria
AT-Innsbruck-IMED, Innsbruck, , Austria
AT-Linz-KEPLER, Linz, , Austria
AT-Linz-ORDENSKLINIKUM, Linz, , Austria
AT-Salzburg-SALK, Salzburg, , Austria
AT-Vienna-HANUSCH, Vienna, , Austria
BE-Antwerpen-ZNASTUIVENBERG, Antwerpen, , Belgium
BE-Brugge-AZBRUGGE, Brugge, , Belgium
BE-Brussel-BORDET, Brussels, , Belgium
BE-Bruxelles-STLUC, Brussels, , Belgium
BE-Gent-UZGENT, Gent, , Belgium
BE-Haine-Saint-Paul-JOLIMONT, Haine-Saint-Paul, , Belgium
BE-Hasselt-VIRGAJESSE, Hasselt, , Belgium
BE-Leuven-UZLEUVEN, Leuven, , Belgium
BE-Liege-CHRCITADELLE, Liège, , Belgium
BE-Liege-CHULIEGE, Liège, , Belgium
BE-Mons-AMBROISE, Mons, , Belgium
BE-Roeselare-AZDELTA, Roeselare, , Belgium
BE-Yvoir-MONTGODINNE, Yvoir, , Belgium
FI-Helsinki-HUS, Helsinki, , Finland
FI-Tampere-TAYS, Tampere, , Finland
FR-Amiens-CHUAMIENS, Amiens, , France
FR-Angers-CHUANGERS, Angers, , France
FR-Argenteuil-CHARGENTEUIL, Argenteuil, , France
FR-Bayonne-CHCOTEBASQUE, Bayonne, , France
FR-Besançon Cedex-JEANMINJOZ, Besançon, , France
FR-Bobigny-AVICENNE, Bobigny, , France
FR-Le Chesnay cedex-CHVERSAILLES, Chesnay, , France
FR-Clamart-HIAPERCY, Clamart, , France
FR-Clermont-Ferrand-ESTAING, Clermont-Ferrand, , France
FR-Grenoble cedex 9-CHUGRENOBLE, Grenoble cedex 9, , France
FR-Lille-CHULILLE, Lille, , France
FR-Limoges-CHULIMOGES, Limoges, , France
FR-Lyon Pierre Benite cedex-LYONSUD, Lyon, , France
FR-Lyon-LEONBERARD, Lyon, , France
FR-Marseille-IPC, Marseille, , France
FR-Montpellier-STELOI, Montpellier, , France
FR-Nantes-CHUNANTES, Nantes, , France
FR-Nice-CAL, Nice, , France
FR-Nice-LARCHET, Nice, , France
FR-Paris cedex 10-SAINTLOUIS, Paris, , France
FR-Paris cedex 15-NECKER, Paris, , France
FR-Pessac Cedex-CHUBORDEAUX, Pessac, , France
FR-Poitiers-CHUPOITERS, Poitiers, , France
FR-Reims-CHREIMS, Reims, , France
FR-Rennes cedex 9-CHURENNES, Rennes, , France
FR-Rouen cedex-BECQUEREL, Rouen, , France
FR-Saint-Priest-en-Jarez-ICLOIRE, Saint-Priest-en-Jarez, , France
FR-Strasbourg cedex-HAUTEPIERRE, Strasbourg, , France
FR-Toulouse-CHUTOULOUSE, Toulouse, , France
FR-Tours cedex-BRETONNEAU, Tours, , France
FR-Vandoeuvre Les Nancy-CHRUNANCY, Vandœuvre-lès-Nancy, , France
FR-Villejuif-GUSTAVEROUSSY, Villejuif, , France
DE-Aschaffenburg-KLINIKUMAB, Aschaffenburg, , Germany
DE-Bad Saarow-HELIOSBADSAAROW, Bad Saarow, , Germany
DE-Berlin-CAMPUSBENFRANKLIN, Berlin, , Germany
DE-Berlin-CAMPUSMITTE, Berlin, , Germany
DE-Berlin-CAMPUSVIRCHOW, Berlin, , Germany
DE-Berlin-VIVANTESNEUKOLLN, Berlin, , Germany
DE-Berlin-VIVANTESURBAN, 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-Dortmund-JOHODORTMUND, Dortmund, , Germany
DE-Düsseldorf-MEDUNIDUESSELDORF, Düsseldorf, , Germany
DE-Essen-KEM, Essen, , Germany
DE-Esslingen-KLINIKUMESSLINGEN, Esslingen, , Germany
DE-Flensburg-MALTESER, Flensburg, , Germany
DE-Frankfurt-KLINIKUMFRANKFURT, Frankfurt, , Germany
DE-Giessen-UKGM, Gießen, , Germany
DE-Goch-KKLE, Goch, , Germany
DE-Greifswald-UNIGREIFSWALD, Greifswald, , Germany
DE-Hamburg-ASKLEPIOSSTGEORG, Hamburg, , Germany
DE-Hamburg-ASKLEPIOS, Hamburg, , Germany
DE-Hamburg-UKE, Hamburg, , Germany
DE-Hamm-EVKHAMM, Hamm, , Germany
DE-Hanau-KLINIKUMHANAU, Hanau, , Germany
DE-Hannover-MHHANNOVER, Hannover, , Germany
DE-Hannover-SILOAHKRH, Hannover, , Germany
DE-Heilbronn-SLK, Heilbronn, , Germany
DE-Herne-MARIENHOSPITALHERNE, Herne, , Germany
DE-Homburg-UNIKLINIKSAARLAND, Homburg, , Germany
DE-Kaiserslautern-WESTPFALZ, Kaiserslautern, , Germany
DE-Karlsruhe-KLINIKUMKARLSRUHE, Karlsruhe, , Germany
DE-Lemgo-KLINIKUMLIPPE, Lemgo, , Germany
DE-Ludwigshafen-KLILU, Ludwigshafen, , Germany
DE-Lübeck-UKSHLUBECK, Lübeck, , Germany
DE-Luedenscheid-KLINIKUMLUEDENSCHEID, Lüdenscheid, , Germany
DE-Magdeburg-OVGU, Magdeburg, , Germany
DE-Mainz-UNIMEDIZINMAINZ, Mainz, , Germany
DE-Meschede-HOCHSAUERLAND, Meschede, , Germany
DE-Minden-MUEHLENKREISKLINKEN, Minden, , Germany
DE-München-IRZTUM, München, , Germany
DE-Offenburg-ORTENAUKLINIKUM, Offenburg, , Germany
DE-Oldenburg-KLINIKUMOLDENBURG, Oldenburg, , Germany
DE-Passau-KLINIKUMPASSAU, Passau, , Germany
DE-Regensburg-UKR, Regensburg, , Germany
DE-Saarbrücken-CARITASKLINIKUM, Saarbrücken, , Germany
DE-Stuttgart-DIAKSTUTTGART, Stuttgart, , Germany
DE-Stuttgart-KLINIKUMSTUTTGART, Stuttgart, , Germany
DE-Trier-MUTTERHAUS, Trier, , Germany
DE-Tübingen-MEDUNITUEBINGEN, Tübingen, , Germany
DE-Ulm-UNIKLINKULM, Ulm, , Germany
DE-Villingen-Schwenningen-SBKVS, Villingen-Schwenningen, , Germany
DE-Wuppertal-HELIOSGESUNDHEIT, Wuppertal, , Germany
IE-Cork-CUH, Cork, , Ireland
IE-Dublin 24-TUH, Dublin, , 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-Co. Limerick-UHL, Limerick, , Ireland
LT-Vilnius-SANTA, Vilnius, , Lithuania
LU-Luxembourg-CHL, Luxembourg, , Luxembourg
NL-Amersfoort-MEANDERMC, Amersfoort, , Netherlands
NL-Amsterdam-AMC, Amsterdam, , Netherlands
NL-Amsterdam-OLVG, Amsterdam, , Netherlands
NL-Amsterdam-VUMC, Amsterdam, , Netherlands
NL-Arnhem-RIJNSTATE, Arnhem, , Netherlands
NL-Breda-AMPHIA, Breda, , Netherlands
NL-Delft-RDGG, Delft, , Netherlands
NL-Den Bosch-JBZ, Den Bosch, , Netherlands
NL-Den Haag-HAGA, Den Haag, , Netherlands
NL-Dordrecht-ASZ, Dordrecht, , Netherlands
NL-Eindhoven-MAXIMAMC, Eindhoven, , Netherlands
NL-Enschede-MST, Enschede, , Netherlands
NL-Groningen-UMCG, Groningen, , Netherlands
NL-Leeuwarden-MCL, 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-Utrecht-UMCUTRECHT, Utrecht, , Netherlands
NL-Zwolle-ISALA, Zwolle, , Netherlands
NO-Bergen-HELSEBERGEN, Bergen, , Norway
NO-Oslo-OSLOUH, Oslo, , Norway
NO-Stavanger-HELSESTAVANGER, Stavanger, , Norway
NO-Tromsø-NORTHNOORWEGEN, Tromsø, , Norway
NO-Trondheim-STOLAV, Trondheim, , Norway
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-Barcelona-VHEBRON, Barcelona, , Spain
ES-Girona-ICSTRUETA, Girona, , Spain
ES-Lleida-ICSVILANOVA, Lleida, , Spain
ES-Madrid-CSGREGORIOMARANON, Madrid, , Spain
ES-Palma-HSLL, Palma, , Spain
ES-Palma-SSIB, Palma, , Spain
ES-Tarragona-JOAN, Tarragona, , Spain
ES-Valencia-MALVARROSA, Valencia, , Spain
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-Fribourg-HFR, Fribourg, , Switzerland
CH-Geneve (14)-HCUGE, Geneve, , Switzerland
CH-Lausanne-CHUV, Lausanne, , Switzerland
CH-Luzern-LUKS, Luzern, , Switzerland
CH-St. Gallen-KSSG, Saint Gallen, , Switzerland
CH-Zürich-USZ, Zürich, , Switzerland
Contact Details
Name: M. Raaijmakers, Prof. Dr.
Affiliation: Erasmus MC / HOVON
Role: PRINCIPAL_INVESTIGATOR
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