NCT05364424

A Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Glofitamab in Combination With Rituximab Plus Ifosfamide, Carboplatin Etoposide Phosphate in Participants With Relapsed/Refractory Transplant or CAR-T Therapy Eligible Diffuse B-Cell Lymphoma

A Phase IB, Open-Label, Multicenter, Single Arm Study Evaluating the Preliminary Efficacy, Safety, and Pharmacokinetics of Glofitamab in Combination With Rituximab Plus Ifosfamide, Carboplatin Etoposide Phosphate in Patients With Relapsed/Refractory Transplant or CAR-T Therapy Eligible Diffuse B-Cell Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the preliminary efficacy, safety, and pharmacokinetics of glofitamab (glofit) in combination with rituximab plus ifosfamide, carboplatin, and etoposide (R-ICE) in participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have failed one prior line of therapy incorporating an anti-cluster of differentiation (CD) 20 antibody (i.e., rituximab) and an anthracycline, and who are transplant or chimeric antigen receptor T-cell (CAR-T) therapy eligible, defined as being medically eligible for intensive platinum-based salvage therapy followed by autologous stem cell transplantation (ASCT) or for CAR-T therapy.

Conditions

• Diffuse Large B-Cell Lymphoma (DLBCL)

Interventions

Type	Name	Description
DRUG	Glofitamab	Participants will receive intravenous (IV) glofitamab for up to 3 cycles.
DRUG	Obinutuzumab	Participants will receive IV obinutuzumab on Cycle 1 Day 1.
DRUG	Tocilizumab	Participants will receive IV tocilizumab as necessary to manage cytokine release syndrome (CRS) events.
DRUG	Rituximab	Participants will receive up to 2 doses of IV rituximab.
DRUG	Ifosfamide	Participants will receive IV ifosfamide for up to 3 cycles.
DRUG	Carboplatin	Participants will receive IV carboplatin for up to 3 cycles.
DRUG	Etoposide	Participants will receive IV etoposide for up to 3 cycles.

Timeline

• Start date: 2022-11-04
• Primary completion: 2025-10-15
• Completion: 2025-10-15
• First posted: 2022-05-06
• Last updated: 2025-12-01

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study