DSHNHL 2015-1 (NIVEAU) (R/R)

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 (Niveau)

Study treatment

• Standard treatment: 8 cycles of gemcitabine + oxaliplatin + rituximab
• Experimental treatment: 8 cycles of nivolumab + gemcitabine + oxaliplatin + rituximab, followed by additional 18 infusions of nivolumab as consolidation or up to progression or unacceptable toxicity

Inclusion criteria

• first relapse or progression of an aggressive Non-Hodgkin's lymphoma
• >65 years of age or older than 18 years if HCT-CI score > 2 or patients who underwent prior autologous stem cell transplantation and are not eligible for allogeneic stem cell transplantation
• ECOG score 0-2
• only one prior chemotherapy regimen including an anthracycline

Exclusion criteria

• already initiated lymphoma therapy after first relapse or progression
• Prolongation of QTc interval > 450 ms
• previous therapy with nivolumab, gemcitabine or oxaliplatin

Participating sites

• CHU UCL Cliniques Universitaires St-Luc
• Institut Jules Bordet
• Universitair ziekenhuis Gent
• CHU de Liège
• CHU- UCL Mont-Godinne