NCT03366272

Nivolumab With Gemcitabine, Oxaliplatin + Rituximab in r/r Elderly Lymphoma Patients

Improvement of Outcome in Elderly Patients or Patients Not Eligible for High-dose Chemotherapy With Aggressive NHL in First Relapse/Progression by Adding Nivolumab to Gemcitabine, Oxaliplatin Plus Rituximab in Case of B-cell Lymphoma

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 348 (actual)
• Sponsor: Universität des Saarlandes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the addition of nivolumab to gemcitabine, oxaliplatin plus rituximab in case of B-cell lymphoma

Detailed description

International, multicentre, randomised, open-label, treatment optimisation study, preceded by safety run-in phases conducted for B-cell and T-cell lymphoma separately.

Conditions

• Lymphoma, Non-Hodgkin

Interventions

Type	Name	Description
DRUG	Nivolumab	eight cycles of nivolumab (240 mg flatdose) plus (R)-GemOx in 2-wk intervals followed by additional 9 infusions of Nivolumab (480 mg flatdose) in 4-wk intervals as consolidation or up to progression or unacceptable toxicity, whatever occurs first
DRUG	Rituximab	eight cycles of R-GemOx in 2-wk intervals
DRUG	Gemcitabine	eight cycles of (R)-GemOx in 2-wk intervals
DEVICE	Oxaliplatin	eight cycles of (R)-GemOx in 2-wk intervals

Timeline

• Start date: 2017-12-05
• Primary completion: 2025-01-15
• Completion: 2025-01-15
• First posted: 2017-12-08
• Last updated: 2025-01-28

Locations

77 sites across 8 countries: Austria, Belgium, France, Germany, Israel, Netherlands, Poland, Portugal