A Study Evaluating the Safety and Efficacy of Glofitamab or Mosunetuzumab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and High-Grade Large B-Cell Lymphoma

PHASE1CompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

June 4, 2020

Primary Completion Date

October 26, 2021

Study Completion Date

October 26, 2021

Conditions
B-cell Lymphoma
Interventions
DRUG

Glofitamab

Participants will receive intravenous (IV) glofitamab in combination with gemcitabine and oxaliplatin for up to 8 cycles, followed by up to 4 cycles of glofitamab monotherapy.

DRUG

Gemcitabine

Participants will receive IV gemcitabine prior to oxaliplatin administration for up to 8 cycles.

DRUG

Oxaliplatin

Participants will receive IV oxaliplatin after gemcitabine administration for up to 8 cycles.

DRUG

Mosunetuzumab

Participants will receive IV mosunetuzumab in combination with gemcitabine and oxaliplatin for up to 8 cycles.

DRUG

Obinutuzumab

Participants will receive a single dose of IV obinutuzumab 7 days prior to the first administration of glofitamab.

DRUG

Tocilizumab

Participants will receive IV tocilizumab as needed to treat cytokine release syndrome (CRS).

Trial Locations (3)

2031

Prince of Wales Hospital; Haematology, Randwick

3065

St Vincent's Hospital Melbourne, Fitzroy

3168

Monash Health Monash Medical Centre, Clayton

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT04313608 - A Study Evaluating the Safety and Efficacy of Glofitamab or Mosunetuzumab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and High-Grade Large B-Cell Lymphoma | Biotech Hunter | Biotech Hunter