Obinutuzumab in Marginal Zone Lymphoma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

November 23, 2018

Primary Completion Date

January 31, 2027

Study Completion Date

January 31, 2027

Conditions
Marginal Zone Lymphoma
Interventions
DRUG

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"

Trial Locations (12)

37075

Universitätsmedizin Georg-August-University, Göttingen

44791

Augusta-Kranken-Anstalt gGmbH, Bochum

45147

University Hospital Essen, Essen

48149

Gemeinschaftspraxis für Hämatologie und Onkologie, Münster

University Hospital Münster, Münster

55101

University Hospital Mainz, Mainz

56068

Institut für Versorgungsforschung GbR, Koblenz

68167

Universitätsklinikum Mannheim, Mannheim

79106

Universitätsklinikum Freiburg, Freiburg im Breisgau

89081

University Hospital Ulm, Ulm

94032

Klinikum Passau, Passau

06120

University Hospital Halle, Halle

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

University of Ulm

OTHER

collaborator

Optimapharm

INDUSTRY

collaborator

Zentrum für Klinische Studien Ulm

OTHER

collaborator

X-act Cologne Clinical Research GmbH

INDUSTRY

collaborator

Roche Pharma AG

INDUSTRY

lead

Christian Buske

OTHER

NCT03322865 - Obinutuzumab in Marginal Zone Lymphoma | Biotech Hunter | Biotech Hunter