A Study to Evaluate the Optimization of the Cytokine Release Syndrome Profile for Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed/Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

This Phase II trial evaluates the optimization of the cytokine release syndrome (CRS) profile for glofitamab in combination with gemcitabine and oxaliplatin (Glofit-GemOx) in participants with relapsed or refractory aggressive B-cell Non-Hodgkin's lymphoma. The study utilizes an optimized steroid premedication regimen and monitoring schedule specifically designed to enable the administration of the treatment regimen in an outpatient setting.

Trial Details

NCT ID
NCT06806033
Phase
PHASE2
Sponsor
Hoffmann-La Roche
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • Obinutuzumab
  • Glofitamab
  • Gemcitabine
  • Oxaliplatin
Locations (sample)
  • Anchorage, Alaska, United States|61.21806,-149.90028
  • Clovis, California, United States|36.82523,-119.70292
  • Los Angeles, California, United States|34.05223,-118.24368
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Gainesville, Florida, United States|29.65163,-82.32483

Key Eligibility Criteria

  • Histologically confirmed large B-cell lymphoma (de novo or transformed from FL) with one of the following diagnoses according to World Health Organ…
  • R/R disease, defined as: relapsed = disease that has recurred following a response that lasted \>/= 6 months after completion of the last line of t…
  • At least one line of prior systemic therapy
  • Participants who have failed only one prior line of therapy must not be a candidate for high-dose chemotherapy followed by autologous stem cell tra…

For full eligibility, visit ClinicalTrials.gov.

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