Title
A Phase III, Multicenter, Randomized, Open-Label Study Comparing The Efficacy and Safety of Glofitamab (RO7082859) In Combination With Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, And Prednisone (Pola-R-Chp) Versus Pola-R-Chp in Previously Untreated Patients With Large B-Cell Lymphoma

Description
A Phase III, Multicenter, Randomized, Open-Label Study Comparing the Efficacy and Safety of Glofitamab (RO7082859) in Combination With Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP) Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma

Objective
Primary
-To evaluate the efficacy of glofitamab in combination with Pola-R-CHP compared with Pola-R-CHP

Secondary
-To evaluate the efficacy of glofitamab in combination with Pola-R-CHP compared with Pola-R-CHP in patients with IPI 3-5
-To evaluate the efficacy of glofitamab in combination with Pola-R-CHP compared with Pola-R-CHP in participants classified to be high-risk based on ctDNA
-To evaluate the safety of glofitamab in combination with Pola-R-CHP compared with Pola-R-CHP
-To characterize the glofitamab PK profile in combination with Pola-R-CHP
-To evaluate the immunogenicity of glofitamab in combination with Pola-R-CHP
-To evaluate the health-related quality of life (HRQoL) of participants treated with glofitamab in combination with Pola-R-CHP

Treatment The purpose of this study is to compare the efficacy and safety of glofitamab in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) vs Pola-R-CHP in participants with previously untreated CD20-positive large B-cell lymphoma (LBCL).

Key Eligibility Inclusion Criteria:

Previously untreated participants with CD20-positive LBCL

Ability to provide tumor tissue

International prognostic index (IPI) score 2-5

Eastern cooperative oncology group (ECOG) performance status of 0, 1, or 2

At least one bi-dimensionally measurable lesion, defined as > 1.5 cm in its longest dimension as measured by CT or MRI

Left ventricular ejection fraction (LVEF) >/=50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)

Adequate hematologic function

Negative HIV test at screening with exceptions as defined by the protocol

Negative SARS-CoV-2 antigen or PCR test

Applicable Disease Sites
Lymphoma

Participating Institutions
UW Health 1 S. Park Medical Center; UW Health Eastpark Medical Center; UW Health University Hospital