A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-cell Non-hodgkin's Lymphoma

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

920

Participants

Timeline

Start Date

February 21, 2017

Primary Completion Date

December 31, 2029

Study Completion Date

December 31, 2029

Conditions
Non-Hodgkin's Lymphoma
Interventions
DRUG

Glofitamab

Glofitamab will be administered at a dose and as per the schedule specified in the respective arms.

DRUG

Obinutuzumab

Obinutuzumab 1000 mg single dose IV infusion on Day -7; or 2000 mg single dose administered on Day -7, or split into two 1000 mg doses administered on Days -1 and -7, and per the schedule specified in the respective arms.

DRUG

Tocilizumab

Tocilizumab will be administered as an IV infusion, if required, for the management of severe Cytokine Release Syndrome (CRS) occurring during or after any infusion of glofitamab, as per the methods described in the Summary of Product Characteristics (SmPC) or other similar local prescribing documents.

Trial Locations (38)

100

ACTIVE_NOT_RECRUITING

National Taiwan Universtiy Hospital, Taipei

404

RECRUITING

China Medical University Hospital, Taichung

1023

ACTIVE_NOT_RECRUITING

Auckland Cancer Trial Centre, Auckland

1200

RECRUITING

Cliniques Universitaires St-Luc, Brussels

2031

ACTIVE_NOT_RECRUITING

Prince of Wales Hospital, Randwick

2100

RECRUITING

Rigshospitalet, København Ø

3000

RECRUITING

Peter Maccallum Cancer Centre, Melbourne

9000

RECRUITING

UZ Gent, Ghent

10029

ACTIVE_NOT_RECRUITING

Mount Sinai Medical Center, New York

10065

COMPLETED

MSKCC, New York

10126

WITHDRAWN

A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette, Turin

15212

ACTIVE_NOT_RECRUITING

Allegheny Health Network (Pittsburg PA), Pittsburgh

20089

ACTIVE_NOT_RECRUITING

Istituto Clinico Humanitas, Rozzano

20133

RECRUITING

Fond. IRCCS Istituto Nazionale Tumori, Milan

28041

ACTIVE_NOT_RECRUITING

Hospital Univ. 12 de Octubre, Madrid

34295

RECRUITING

CHU Saint Eloi, Montpellier

35033

RECRUITING

CHU DE RENNES - CHU Pontchaillou, Rennes

39008

ACTIVE_NOT_RECRUITING

Hospital Universitario Marques de Valdecilla, Santander

48121

RECRUITING

AUSL della Romagna, Ravenna

59037

RECRUITING

Hopital Claude Huriez, Lille

60426

WITHDRAWN

Ingalls Memorial Hospital, Harvey

63110

RECRUITING

Washington University, St Louis

69495

RECRUITING

Ch Lyon Sud, Pierre-Bénite

84112

WITHDRAWN

Hunstman Cancer Institute, Salt Lake City

94010

RECRUITING

Hopital Henri Mondor, Créteil

98104

ACTIVE_NOT_RECRUITING

Swedish Cancer Inst., Seattle

48109-0934

ACTIVE_NOT_RECRUITING

University of Michigan, Ann Arbor

M5G 1Z5

ACTIVE_NOT_RECRUITING

Princess Margaret Cancer Center, Toronto

128 08

ACTIVE_NOT_RECRUITING

Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK, Prague

00029

RECRUITING

Helsinki University Central Hospital, Helsinki

80-214

ACTIVE_NOT_RECRUITING

Uniwersyteckie Centrum Kliniczne, Gda?sk

60-569

RECRUITING

Uniwersytecki Szpital Kliniczny w Poznaniu, Późna

02-781

WITHDRAWN

Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie, Warsaw

50-367

ACTIVE_NOT_RECRUITING

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu, Wroc?aw

08915

ACTIVE_NOT_RECRUITING

Hospital Universitari Germans Trias i Pujol, Badalona

08908

ACTIVE_NOT_RECRUITING

Hospital Duran i Reynals L'Hospitalet, L'Hospitalet de Llobregat

08003

ACTIVE_NOT_RECRUITING

Hospital del Mar, Barcelona

08035

RECRUITING

Hospital Universitari Vall d'Hebron, Barcelona

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY