A Multicentre, Parallel Arm, Open-label Trial of Frontline R-CHOP/Pola-RCHP and Glofitamab in Younger, Higher Risk Patients With Diffuse Large B Cell Lymphoma (DLBCL)

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

June 29, 2021

Primary Completion Date

December 5, 2023

Study Completion Date

July 31, 2025

Conditions
Diffuse Large B Cell LymphomaHigh-grade B-cell Lymphoma
Interventions
DRUG

Rituximab

Rituximab 375 mg/m\^2 administered by IV infusion on Day 1 of every 21-day cycle

DRUG

Cyclophosphamide

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

DRUG

Doxorubicin

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

DRUG

Vincristine

Vincristine 1.4mg/m\^2 administered by IV infusion on Day 1 of every 21-day cycle

DRUG

Prednisolone

Prednisolone 100mg orally on Days 1-5 of every 21-day cycle

DRUG

Glofitamab

Glofitamab will be administered by IV infusion as per the schedule specified in the respective arm

DRUG

Polatuzumab vedotin

Polatuzumab 1.8mg/kg administered by IV infusion on Day 1 of every 21-day cycle

Trial Locations (15)

2010

St Vincent's Public Hospital Sydney, Darlinghurst

2031

Prince of Wales Hospital, Randwick

2050

Concord Repatriation General Hospital, Camperdown

2298

Calvary Mater Newcastle, Newcastle

3000

Peter MacCallum Cancer Centre, Melbourne

3065

St Vincent's Hospital Melbourne, Melbourne

3128

Box Hill Hospital, Box Hill

3144

Cabrini Hospital, Malvern

3220

Barwon Health, Geelong

4029

Royal Brisbane and Women's Hospital, Herston

4102

Princess Alexander Hospital, Woolloongabba

5000

Royal Adelaide Hospital, Adelaide

6009

Sir Charles Gairdner Hospital, Nedlands

Unknown

Alfred Hospital, Melbourne

Epworth Healthcare, Melbourne

All Listed Sponsors
collaborator

Hoffmann-La Roche

INDUSTRY

lead

Peter MacCallum Cancer Centre, Australia

OTHER