56
Participants
Start Date
November 23, 2018
Primary Completion Date
January 31, 2027
Study Completion Date
January 31, 2027
Obinutuzumab
"Induction:~Cycle 1 (28 days cycle): Obinutuzumab (OBINUTUZUMAB) 1000mg i.v. fixed dose day 1,8,15\*~\*In the case of suspected increased risk of severe IRR, the dose of obinutuzumab may be 100 mg intravenously on day 1 in cycle 1, 900 mg on day 2.~Cycle 2-6 (28 days cycle): Obinutuzumab (OBINUTUZUMAB) 1000mg i.v. fixed dose day 1 Maintenance~Start 8 weeks after the last induction cycle for patients at least achieving a partial response after induction:~Obinutuzumab (OBINUTUZUMAB) 1000mg i.v. fixed dose day 1 every 8 weeks for a maximum of 12 infusions unless progression or study drug - related intolerable toxicity"
Universitätsmedizin Georg-August-University, Göttingen
Augusta-Kranken-Anstalt gGmbH, Bochum
University Hospital Essen, Essen
Gemeinschaftspraxis für Hämatologie und Onkologie, Münster
University Hospital Münster, Münster
University Hospital Mainz, Mainz
Institut für Versorgungsforschung GbR, Koblenz
Universitätsklinikum Mannheim, Mannheim
Universitätsklinikum Freiburg, Freiburg im Breisgau
University Hospital Ulm, Ulm
Klinikum Passau, Passau
University Hospital Halle, Halle
Collaborators (1)
University of Ulm
OTHER
Optimapharm
INDUSTRY
Zentrum für Klinische Studien Ulm
OTHER
X-act Cologne Clinical Research GmbH
INDUSTRY
Roche Pharma AG
INDUSTRY
Christian Buske
OTHER