111
Participants
Start Date
March 13, 2018
Primary Completion Date
December 2, 2024
Study Completion Date
December 2, 2024
Glofitamab
Glofitamab will be administered intravenously (IV) as a step-up dose for Cycle 2 on Days 8 and 15, and as a single dose from Cycle 3 onwards.
Obinutuzumab (G)
Obinutuzumab 1000 mg single dose IV infusion on Day 1 of Cycle 1 only
Rituximab (R)
Rituximab will be administered as an IV infusion at a dose of 375 mg/m\^2 on Day 1 of each 21-day cycle starting from Cycle 1 to Cycle 6 (Part 1) or from Cycles 1-6 (up to 8) (Part 2: DLBCL R-CHOP).
Tocilizumab
Tocilizumab will be administered as an IV infusion as per the methods described in the Summary of Product Characteristics (SmPC) or other similar local prescribing documents. Tocilizumab will be given as rescue medication.
Cyclophosphamide
Cyclophosphamide 750 mg/m\^2 administered IV on Day 1 of each 21-day cycle
Doxorubicin
Doxorubicin 50 mg/m\^2 administered IV on Day 1 of each 21-day cycle
Vincristine
Vincristine 1.4 mg/m\^2 administered by IV push on Day 1 of each 21-day cycle with a recommended cap of 2 mg
Prednisone
Prednisone 100 mg/day orally on Days 1-5 (prednisone on Day 1 may be administered IV, with the remaining doses on Days 2-5 to be administered orally) of each 21-day cycle
Polatuzumab vedotin
Polatuzumab vedotin 1.8 mg/kg administered IV on Day 1 of each 21-day cycle
Rigshospitalet, København Ø
Peter Maccallum Cancer Centre, Melbourne
Fox Chase-Temple Cancer Center, Philadelphia
Istituto Clinico Humanitas, Rozzano
Asst Papa Giovanni Xxiii, Bergamo
START Madrid-FJD, Hospital Fundacion Jimenez Diaz, Madrid
Levine Cancer Institute, Charlotte
University of Alabama Medical Center, Birmingham
Hopital Hotel Dieu Et Hme, Nantes
UO Ematologia, Ospedale S.Maria delle Croci, Ravenna
Hopital Claude Huriez, Lille
Centre Henri Becquerel, Rouen
Universitätsklinikum Freiburg, Freiburg im Breisgau
Istituto Nazionale Tumori Irccs Fondazione g. Pascale, Napoli
Universitätsklinikum Ulm, Ulm
Universitätsklinikum Erlangen, Translational Research Center (TRC), Medizin 5, Erlangen
Universitätsklinikum Würzburg, Würzburg
Princess Margaret Cancer Center, Toronto
Hospital Universitari Vall d'Hebron, Barcelona
Hospital Clínic i Provincial, Barcelona
University College London Hospitals NHS Foundation Trust, London
Nottingham University Hospitals NHS Trust - City Hospital, Nottingham
Hoffmann-La Roche
INDUSTRY