30
Participants
Start Date
December 15, 2021
Primary Completion Date
April 30, 2026
Study Completion Date
April 30, 2026
Blinatumomab
"All patients with hematological relapse will additionally receive Blinatumomab immunotherapy (first cycle: 9 ug/d c.i.v. on d1 until d7 and 28 ug/d c.iv. on d8 until d28; second cycle: 28 ug/d c.iv. on d1 to d28) in six-week cycles (4 weeks on Blinatumomab, 2 weeks off Blinatumomab).~All patients with molecular relapse will additionally receive Blinatumomab immunotherapy at 28 ug/d c.iv. on d1 until d28 in six-week cycles (4 weeks on Blinatumomab, 2 weeks off Blinatumomab.)~Patients eligible for a second cycle shall not receive Blinatumomab starting dose independent from relapse type."
Venetoclax
"In phase I of the study all eligible patients will receive increasing doses of Venetoclax on days -7 to -1 (Venetoclax dose-titration) in the first cycle and continuous dosing of Venetoclax at a pre-specified target dose (TD, p.o., once daily, d1 to d42) in six-week cycles for a maximum of two cycles.~In phase II of the study all eligible patients will receive the recommended phase 2 dose (RP2D) of Venetoclax in six-week cycles for a maximum of two cycles. RP2D will be MTD.~Patients eligible for a second cycle shall not receive Venetoclax dose-titration independent from relapse type."
Charité - Campus Benjamin Franklin, Berlin
Universitätsklinikum Hamburg-Eppendorf, Hamburg
Klinikum Oldenburg, Oldenburg
University Hospital Düsseldorf, Düsseldorf
Universitätsklinikum Köln, Cologne
University Hospital of Frankfurt (Main), Frankfurt am Main
Universitätsklinikum Heidelberg, Heidelberg
Universitätsklinikum Tübingen, Tübingen
Klinikum Rechts der Isar der TU München, München
Universitätsklinikum Ulm, Ulm
Universitätsklinikum Dresden, Dresden
Universität Erlangen, Erlangen
Universitätsklinikum Essen, Essen
UKSH-Kiel, Kiel
Universitätsklinik Leipzig, Leipzig
Klinikum Mannheim, Mannheim
Robert - Bosch - Krankenhaus, Stuttgart
Lead Sponsor
University Hospital Schleswig-Holstein
OTHER
Goethe University
OTHER