drugset / Trial / NCT05533775

A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma

NCT05533775

Phase 1/2 Recruiting 65 enrolled Hoffmann-La Roche
NaParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety and efficacy of glofitamab, as monotherapy and in combination with a standard chemoimmunotherapy regimen: rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) in pediatric and young adult participants with relapsed and refractory (R/R) mature B-cell non-Hodgkin lymphoma (B-NHL).

Timeline

Start
2022-11-16
Primary completion
2029-11-30
Completion
2032-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule Intravenous
Subject Etoposide Small molecule Intravenous
Subject Glofitamab Monoclonal antibody Intravenous
Subject Ifosfamide Small molecule Intravenous
Subject Rituximab Monoclonal antibody Intravenous
Background Obinutuzumab Monoclonal antibody Intravenous
Background Tocilizumab Monoclonal antibody Intravenous