650
Participants
Start Date
September 13, 2022
Primary Completion Date
March 31, 2029
Study Completion Date
February 29, 2032
Venetoclax
Venetoclax will be administered in Induction cycle 1, Induction cycle 2 and in the chemo consolidation therapy in addition to the standard chemotherapy
Placebo
Placebo will be administered in Induction cycle 1, Induction cycle 2 and in the chemo consolidation therapy in addition to the standard chemotherapy
Standard chemotherapy
"Induction cycle 1: Patients will receive cytarabine 200 mg/m2 continuous IV (days 1-7) and daunorubicin 60 mg/m2 IV (days 1-3). Induction cycle 2: Patients ≤ 60 yrs will receive cytarabine 1000 mg/m2 BID (3h IV), days 1-4, and daunorubicin 60 mg/m2 IV (days 1-3). Patients \>60 yrs will receive cytarabine 1000 mg/m2 BID (3h IV), days 1-4 without daunorubicin.~Consolidation chemotherapy with intermediate doses of cytarabine. Patients ≤60 yrs will receive up to 3 cycles of IDAC (single dose 1500 mg/m2 every 12 hours, days 1-3). Patients who are \>60 yrs will receive up to 3 cycles of IDAC with single doses of 1000 mg/m2, every 12 hours, days 1-3. In patients \>60 yrs less than 3 cycles of IDAC or dose-reduced IDAC (500 mg/m2 per single dose) may be given based on an individual risk assessment."
Allogeneic stem cell transplantation
Generally, patients will proceed to allogeneic HCT upon completion of remission induction chemotherapy. It is however allowed, as per investigator's discretion, for a patient to receive 'bridging' consolidation chemotherapy in exceptional cases of delay towards transplantation. At baseline, HLA-compatible donor search must be initiated as soon as possible, first among siblings and second in the world donor bank for unrelated donors or cord blood. In order to avoid inappropriate delay in cases where no suitable sibling is present, high-resolution HLA typing should be performed immediately after registration, enabling a more rapid matched-unrelated donor search. In case no sibling or unrelated donor can be identified, haploidentical allogeneic HCT is allowed. Conditioning and GVHD prophylaxis will take place according to institutional guidelines. Patients who undergo allogeneic HCT will not receive venetoclax during conditioning, engraftment or after hematologic recovery.
RECRUITING
Charité Berlin - Campus Mitte, Berlin
RECRUITING
Charité Berlin - Campus Benjamin Franklin, Berlin
RECRUITING
Universitätsklinikum Hamburg-Eppendorf, Hamburg
RECRUITING
Medizinische Hochschule Hannover, Hanover
RECRUITING
Staedtisches Klinikum Braunschweig, Braunschweig
RECRUITING
Knappschaftskrankenhaus Bochum-Langendreer, Bochum
RECRUITING
Uniklinikum Bonn, Bonn
RECRUITING
Diakonie Klinikum Stuttgart, Stuttgart
RECRUITING
Uniklinikum Tübingen, Tübingen
RECRUITING
Städtisches Klinikum Karlsruhe, Karlsruhe
RECRUITING
University Hospital Ulm, Ulm
NOT_YET_RECRUITING
Tirol Kliniken GmbH, Innsbruck
NOT_YET_RECRUITING
Kepler Universitaetsklinikum GmbH, Linz
NOT_YET_RECRUITING
Ordensklinikum Linz GmbH, Linz
NOT_YET_RECRUITING
Landeskrankenhaus (LKH) Rankweil, Interne E am Landeskrankenhaus Rankweil, Rankweil
NOT_YET_RECRUITING
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH, Salzburg
NOT_YET_RECRUITING
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse, Vienna
NOT_YET_RECRUITING
Ziekenhuis Aan De Stroom, Antwerp
NOT_YET_RECRUITING
Az St-Jan Brugge-Oostende A.V., Bruges
NOT_YET_RECRUITING
Universitair Ziekenhuis Brussel, Brussels
NOT_YET_RECRUITING
Katholieke Universiteit te Leuven, Leuven
NOT_YET_RECRUITING
Algemeen Ziekenhuis Delta, Roeselare
NOT_YET_RECRUITING
CHU UCL NAMUR - Mont Godinne, Yvoir
NOT_YET_RECRUITING
North Estonia Medical Centre Foundation, Tallinn
NOT_YET_RECRUITING
Tartu University Hospital, Tartu
NOT_YET_RECRUITING
Helsinki University Central Hospital Meilahden Kolmiosairaala, Helsinki
NOT_YET_RECRUITING
Tampere University Hospital, Tampere
RECRUITING
Klinikum Aschaffenburg-Alzenau gGmbH, Aschaffenburg
NOT_YET_RECRUITING
HELIOS Klinikum Bad Saarow GmbH, Bad Saarow
RECRUITING
Charité Berlin - Campus Virchow Klinikum, Berlin
NOT_YET_RECRUITING
Vivantes am Urban, Berlin
NOT_YET_RECRUITING
Vivantes Neukölln, Berlin
WITHDRAWN
Vivantes Spandau, Berlin
RECRUITING
Gesundheit Nord gGmbH Klinikverbund Bremen, Bremen
NOT_YET_RECRUITING
Klinikum Darmstadt GmbH, Darmstadt
NOT_YET_RECRUITING
St. Johannes Hospital Dortmund, Dortmund
NOT_YET_RECRUITING
Marien Hospital Duesseldorf GmbH, Düsseldorf
NOT_YET_RECRUITING
Klinikum Frankfurt Hoechst GmbH, Frankfurt
RECRUITING
Justus-Liebig-Universitaet Giessen, Giessen
RECRUITING
Wilhelm-Anton-Hospital Goch, Goch
NOT_YET_RECRUITING
Universitätsmedizin Greifswald, Greifswald
NOT_YET_RECRUITING
Asklepios Klinik Altona, Hamburg
RECRUITING
Asklepios Klinik St Georg, Hamburg
NOT_YET_RECRUITING
KRH Klinikum Siloah, Hanover
NOT_YET_RECRUITING
SLK-Kliniken Heilbronn GmbH, Heilbronn
RECRUITING
Marien Hospital Herne, Herne
NOT_YET_RECRUITING
Universitaetsklinikum des Saarlandes AöR, Homburg
NOT_YET_RECRUITING
Wespfalz-Klinikum, Kaiserslautern
NOT_YET_RECRUITING
Staedtisches Klinikum Karlsruhe gGmbH, Karlsruhe
RECRUITING
Klinikum der Stadt Ludwigshafen am Rhein gGmbH, Ludwigshafen
NOT_YET_RECRUITING
UNIVERSITÄTSKLINIKUM Schleswig-Holstein, Lübeck
NOT_YET_RECRUITING
Otto Von Guericke Universitaet Magdeburg, Magdeburg
NOT_YET_RECRUITING
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR, Mainz
RECRUITING
Klinikum Hochsauerland GmbH, Meschede
NOT_YET_RECRUITING
Muhlenkreiskliniken AöR, Minden
NOT_YET_RECRUITING
Klinikum rechts der Isar der TU Muenchen AöR, München
NOT_YET_RECRUITING
Ortenauklinikum, Offenburg
RECRUITING
Klinikum Oldenburg AöR, Oldenburg
NOT_YET_RECRUITING
Universitaetsklinikum Regensburg AöR, Regensburg
NOT_YET_RECRUITING
Universitaetsklinikum, Rostock
NOT_YET_RECRUITING
Klinikum Traunstein, Traunstein
NOT_YET_RECRUITING
Barmherzige Brueder Trier gGmbH, Trier
NOT_YET_RECRUITING
Klinikum Mutterhaus der Borromaerinnen, Trier
RECRUITING
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH, Villingen-Schwenningen
NOT_YET_RECRUITING
Helios Universitaetsklinikum Wuppertal, Wuppertal
NOT_YET_RECRUITING
Vilnius University Hospital Santaros Klinik, Vilnius
NOT_YET_RECRUITING
Jeroen Bosch ziekenhuis, 's-Hertogenbosch
NOT_YET_RECRUITING
Meander Medisch Centrum, Amersfoort
RECRUITING
Amsterdam UMC Stichting, Amsterdam
NOT_YET_RECRUITING
OLVG, Amsterdam
NOT_YET_RECRUITING
Rijnstate Ziekenhuis Stichting, Arnhem
NOT_YET_RECRUITING
Amphia Hospital, Breda
NOT_YET_RECRUITING
Reinier de Graaf Gasthuis, Delft
NOT_YET_RECRUITING
Albert Schweitzer Ziekenhuis, Dordrecht
NOT_YET_RECRUITING
Maxima Medisch Centrum, Eindhoven
NOT_YET_RECRUITING
Medisch Spectrum Twente, Enschede
NOT_YET_RECRUITING
UMCG, Groningen
NOT_YET_RECRUITING
Medisch Centrum Leeuwarden B.V., Leeuwarden
NOT_YET_RECRUITING
Leids Universitair Medisch Centrum (LUMC), Leiden
NOT_YET_RECRUITING
Maastricht University Medical Center+ (MUMC+), Maastricht
NOT_YET_RECRUITING
Sint Antonius Ziekenhuis Stichting, Nieuwegein
RECRUITING
Radboudumc, Nijmegen
NOT_YET_RECRUITING
Erasmus MC - Daniel, Rotterdam
NOT_YET_RECRUITING
Hagaziekenhuis, locatie Leyweg, The Hague
NOT_YET_RECRUITING
UMCU, Utrecht
NOT_YET_RECRUITING
Isala Klinieken Stichting, Zwolle
NOT_YET_RECRUITING
Haukeland University Hospital, Bergen
NOT_YET_RECRUITING
Stavanger Univ. Hosp.-Rogaland Hosp., Oslo
NOT_YET_RECRUITING
University Hospital of North Norway, Tromsø
NOT_YET_RECRUITING
St. Olavs Hospital, Trondheim
Stichting Hemato-Oncologie voor Volwassenen Nederland
OTHER
University of Ulm
OTHER