NCT04914741

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)

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Peter MacCallum Cancer Centre, Australia · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, multi-centre, phase Ib/II, parallel arm study evaluating the safety and tolerability of glofitamab in addition to backbone chemotherapy consisting of R-CHOP or polatuzumab vedotin-RCHP for younger patients with higher-risk Diffuse Large B-cell Lymphoma or High Grade B-Cell Lymphoma.

Conditions

• Diffuse Large B Cell Lymphoma
• High-grade B-cell Lymphoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-06-29
• Primary completion: 2023-12-05
• Completion: 2025-07-01
• First posted: 2021-06-07
• Last updated: 2024-08-12

Locations

15 sites across 1 country: Australia