Study of Glofitamab Alone and With Chemoimmunotherapy for Children and Young Adults With Relapsed or Refractory Mature B-Cell Non-Hodgkin Lymphoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of glofitamab, alone and combined with a standard chemoimmunotherapy regimen rituximab, ifosfamide, carboplatin, and etoposide, in children and young adults with relapsed or refractory mature B-cell non-Hodgkin lymphoma B-NHL. This Phase III trial focuses on participants who have not responded to prior treatments or whose disease has returned, aiming to better understand treatment responses and side effects. Participants are assigned to one of two groups. One group receives glofitamab combined with R-ICE chemoimmunotherapy for up to three 21-day cycles. The other group receives only glofitamab for up to twelve 21-day cycles. Additional drugs such as obinutuzumab, rituximab, ifosfamide, carboplatin, and etoposide are given intravenously according to specified schedules. Tocilizumab may be used if needed to manage cytokine release syndrome. Treatment cycles and drug administration days vary depending on the group. Throughout the study, participants attend regular visits for up to three or twelve treatment cycles depending on their group. Researchers will assess tumor response, safety, drug levels in the blood, and immune responses. Outcome measures include complete response rates, adverse events, progression-free survival, overall survival, and other clinical outcomes. The study will follow participants for up to approximately 3 to 4 years to monitor long-term effects and outcomes.

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