146
Participants
Start Date
April 7, 2024
Primary Completion Date
September 30, 2028
Study Completion Date
September 30, 2028
Venetoclax plus Azacitidine
"Induction cycle 1:~100 mg venetoclax p.o. on day 1; 200 mg venetoclax p.o. on day 2; 400 mg venetoclax p.o. on days 3-28; 75 mg/m\^2 azacitidine s.c. on days 1-7~Induction cycles 2-3:~400 mg venetoclax p.o. on days 1-28; 75 mg/m\^2 azacitidine s.c. on days 1-7~Postremission cycles 1-9:~400 mg venetoclax p.o. on days 1-28; 75 mg/m\^2 azacitidine s.c. on days 1-7"
standard of care chemotherapy plus gemtuzumab ozogamicin
"Induction cycle 1:~200 mg/m\^2 cytarabine cont inf i.v. on days 1-7; 60 mg/m\^2 daunorubicin i.v. on days 3-5; 3 mg/m\^2 (max 1 vial) gemtuzumab ozogamicin i.v. on days 1+4+7~Induction cycle 2 (patients not in remission, moderate or non-responders):~3000/1000 mg/m\^2 cytarabine i.v. BID on days 1-3; 10 mg/m\^2 mitoxantrone i.v. on days 3-5~Postremission cycles 1-3:~3000/1000 mg/m\^2 cytarabine i.v. BID on days 1-3"
RECRUITING
Universitätsklinikum Schleswig-Holstein, Kiel
RECRUITING
Philipps-Universität Marburg Fachbereich Medizin, Marburg
RECRUITING
Universitätsklinikum Essen, Essen
RECRUITING
Universitätsklinikum Münster, Münster
NOT_YET_RECRUITING
Universiätsklinikum Köln, Cologne
RECRUITING
Universitätsklinikum Aachen, Aachen
RECRUITING
Johann Wolfgang Goethe-Universität, Frankfurt am Main
RECRUITING
Klinikum Mannheim gGmbH, Mannheim
RECRUITING
Universitätsklinikum Heidelberg, Heidelberg
RECRUITING
Robert-Bosch-Krankenhaus, Stuttgart
RECRUITING
Universitätsklinikum Augsburg, Augsburg
RECRUITING
Klinikum Nürnberg-Nord, Nuremberg
RECRUITING
Universitätsklinikum Erlangen, Erlangen
RECRUITING
Krankenhaus Barmherzige Brüder, Regensburg
RECRUITING
Klinikum Chemnitz gGmbH, Chemnitz
RECRUITING
Universitätsklinikum Dresden, Dresden
RECRUITING
Universitätsklinikum Halle, Halle
RECRUITING
Universitätsklinikum Leipzig, Leipzig
Collaborators (1)
University Hospital Heidelberg
OTHER
AbbVie
INDUSTRY
Technische Universität Dresden
OTHER