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)

Phase 1/2 Active not recruiting 80 enrolled Peter MacCallum Cancer Centre, Australia Hoffmann-La Roche · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2021-06-29
Primary completion: 2023-12-05
Completion: 2025-07

Publications

Minson A, Verner E, Giri P, Butler J, Janowski W, Cheah CY, Ratnasingam S, Wong SM, Ku M, Hertzberg M, Herbert K, Hamad N, Yannakou CK, Swain F, Neeson P, Steiner TM, Saghebi J, Blombery P, Hunter SM, Robertson M, Lau LS, Bennett R, Harrop S, Xie J, Seymour JF, Dickinson MJ. Glofitamab Combined With Pola-R-CHP or R-CHOP as First Therapy in Younger Patients With High-Risk Large B-Cell Lymphoma: Results From the COALITION Study. J Clin Oncol. 2025 Aug 10;43(23):2595-2605. doi: 10.1200/JCO-25-00481. Epub 2025 Jun 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Glofitamab	Monoclonal antibody	—	Intravenous
Subject	Polatuzumab Vedotin	Other / unclassified	1.8 mg/kg	Intravenous
Subject	Vincristine	Small molecule	1.4 mg/m2	Intravenous
Background	Cyclophosphamide	Other / unclassified	750 mg/m2	Intravenous
Background	Doxorubicin	Other / unclassified	50 mg/m2	Intravenous
Background	Prednisolone	Other / unclassified	100 mg	Oral
Background	Rituximab	Monoclonal antibody	375 mg/m2	Intravenous

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)

Summary

Timeline

Publications

Drugs

Indications