A Study of Glofitamab in Combination With Rituximab or Obinutuzumab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP), or Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (CHP) in Participants With Non-Hodgkin Lymphomas or With DLBCL

PHASE1CompletedINTERVENTIONAL
Enrollment

111

Participants

Timeline

Start Date

March 13, 2018

Primary Completion Date

December 2, 2024

Study Completion Date

December 2, 2024

Conditions
B-Cell LymphomaNon-Hodgkin Lymphoma
Interventions
DRUG

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.

DRUG

Obinutuzumab (G)

Obinutuzumab 1000 mg single dose IV infusion on Day 1 of Cycle 1 only

DRUG

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).

DRUG

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.

DRUG

Cyclophosphamide

Cyclophosphamide 750 mg/m\^2 administered IV on Day 1 of each 21-day cycle

DRUG

Doxorubicin

Doxorubicin 50 mg/m\^2 administered IV on Day 1 of each 21-day cycle

DRUG

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

DRUG

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

DRUG

Polatuzumab vedotin

Polatuzumab vedotin 1.8 mg/kg administered IV on Day 1 of each 21-day cycle

Trial Locations (22)

2100

Rigshospitalet, København Ø

3000

Peter Maccallum Cancer Centre, Melbourne

19111

Fox Chase-Temple Cancer Center, Philadelphia

20089

Istituto Clinico Humanitas, Rozzano

24127

Asst Papa Giovanni Xxiii, Bergamo

28040

START Madrid-FJD, Hospital Fundacion Jimenez Diaz, Madrid

28204

Levine Cancer Institute, Charlotte

35294

University of Alabama Medical Center, Birmingham

44093

Hopital Hotel Dieu Et Hme, Nantes

48121

UO Ematologia, Ospedale S.Maria delle Croci, Ravenna

59037

Hopital Claude Huriez, Lille

76038

Centre Henri Becquerel, Rouen

79106

Universitätsklinikum Freiburg, Freiburg im Breisgau

80131

Istituto Nazionale Tumori Irccs Fondazione g. Pascale, Napoli

89081

Universitätsklinikum Ulm, Ulm

91054

Universitätsklinikum Erlangen, Translational Research Center (TRC), Medizin 5, Erlangen

97080

Universitätsklinikum Würzburg, Würzburg

M5G 1Z5

Princess Margaret Cancer Center, Toronto

08035

Hospital Universitari Vall d'Hebron, Barcelona

08036

Hospital Clínic i Provincial, Barcelona

W1T 7HA

University College London Hospitals NHS Foundation Trust, London

NG5 1PB

Nottingham University Hospitals NHS Trust - City Hospital, Nottingham

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT03467373 - A Study of Glofitamab in Combination With Rituximab or Obinutuzumab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP), or Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (CHP) in Participants With Non-Hodgkin Lymphomas or With DLBCL | Biotech Hunter | Biotech Hunter