NIVINIHO (FL)

A Prospective Phase II Study Of Nivolumab Alone, Or In Combination With Vinblastin In Patients Aged 61 Years And Older, With Classical Hodgkin Lymphoma And Coexisting Medical Conditions (NIVINIHO)

Study Treatments

• Induction treatment: Nivolumab will be given alone at 240 mg flat dose every 2 weeks (i.e. one cycle) Patients will be assessed after 3 months of therapy.
• Consolidation treatment: depending on the induction evaluation by PET-CT and CT-scan
  • Complete  Metabolic response: nivolumab 240 mg every 2 weeks for 9 months
  • Partial Metabolic response and NMR: Nivolumab+Vinblastin regimen every 2 weeks for 9 additional months: Vinblastin(6 mg/m2 (IV) + Nivolumab 240 mg (IV)
  • Progressive disease: treatment failure

Inclusion criteria

• First diagnosis of classical Hodgkin lymphoma according to WHO criteria excluding nodular lymphocyte predominant subtype
• Age 61 years or older
• Unfit for poly chemotherapy because of co-morbidities evaluated by a Cumulative Illness Rating Scale (CIRS) score ≥6)
• No previous treatment for Hodgkin lymphoma
• Ann Arbor stages: I-IV
• ECOG score 0-3

Exclusion criteria

• Contra-indication to Nivolumab and /or Vinblastin
• Subjects with active interstitial pneumonitis
• Subjects with active infectious disease
• Subjects with active, known or suspected autoimmune disease

Participating sites

• CHU UCL Namur - site Mont-Godinne
• Institut Jules Bordet
• ZNA