NCT04657302

A Study to Evaluate Glofitamab as Single Agent Administered After Pretreatment With Obinutuzumab in Chinese Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

A Phase I, Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Efficacy of Glofitamab as Single Agent Administered After a Fixed, Single Dose Pretreatment of Obinutuzumab in Chinese Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the pharmacokinetics, safety, tolerability, and efficacy of glofitamab as a single agent following a fixed single dose of obinutuzumab in Chinese patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have failed two or more lines of systemic therapy.

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	Obinutuzumab	Participants will receive 1000 mg of intravenous (IV) obinutuzumab on Cycle 1 Day 1.
DRUG	Glofitamab	Participants will receive 2.5 mg of IV glofitamab Cycle 1 Day 8, 10 mg at Cycle 1 Day 15, and 30 mg on Day 1 of Cycles 2-12 Q3W (cycle length = 21 days).
DRUG	Tocilizumab	Participants will receive tocilizumab as needed to manage cytokine release syndrome (CRS).

Timeline

• Start date: 2021-01-08
• Primary completion: 2022-10-25
• Completion: 2024-01-12
• First posted: 2020-12-08
• Last updated: 2024-01-19

Locations

6 sites across 1 country: China