At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase Ib, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Glofitamab or Mosunetuzumab in Combination With Gemcitabine Plus Oxaliplatin in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and High-Grade Large B-Cell Lymphoma
In Brief
A Phase 1 clinical trial evaluating Glofitamab, Gemcitabine, and 4 other interventions for B-cell Lymphoma. Completed, enrolled 23 participants across 3 sites.
Detailed Summary
This study is designed to evaluate the safety and efficacy of glofitamab or mosunetuzumab in combination with gemcitabine and oxaliplatin (Glofit-GemOx or Mosun-GemOx) in participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL).
Study Details
Timeline
Interventions
Participants will receive intravenous (IV) glofitamab in combination with gemcitabine and oxaliplatin for up to 8 cycles, followed by up to 4 cycles of glofitamab monotherapy.
Participants will receive IV gemcitabine prior to oxaliplatin administration for up to 8 cycles.
Participants will receive IV oxaliplatin after gemcitabine administration for up to 8 cycles.
Participants will receive IV mosunetuzumab in combination with gemcitabine and oxaliplatin for up to 8 cycles.
Participants will receive a single dose of IV obinutuzumab 7 days prior to the first administration of glofitamab.
Participants will receive IV tocilizumab as needed to treat cytokine release syndrome (CRS).