Study Of Nivolumab Alone, Or In Combination With Vinblastin In Patients With Classical Hodgkin Lymphoma

Summary

This study is a multicentric phase II open-label trial consisting of 6 cycles Nivolumab (2 weeks interval) followed by a PET-CT scan. The treatment will be allocated according to PET and CT scan responses. : * In case of CMR according to Lugano Classification (Cheson et al.2014, PET-CT based response), patients will receive 18 additional cycles of Nivolumab, according to CT-based response at Cycle 12. * In case of Partial Metabolic Response (PMR) or No Metabolic Response(NMR), according to Lugano Classification (Cheson et al.2014, PET-CT based response) patients will receive 12 to 18 cycles of Nivolumab combined with Vinblastin according to CT-based response at Cycle 12. * In case of progressive disease, according to Lugano Classification (Cheson et al.2014, PET-CT scan based response) patients will be considered in treatment failure.

Timeline

Start

2018-08-31

Primary completion

2021-02-19

Completion

2021-08-12

Publications

• Lazarovici J, Amorim S, Bouabdallah K, Fournier M, Guidez S, Molina L, Morschhauser F, Delapierre B, Gastinne T, Laribi K, Launay V, Slama B, Belmecheri N, Casasnovas RO, Corby A, Durot E, Feugier P, Nicolas-Virelizie E, Sibon D, Berriolo-Riedinger A, Edeline V, Borght TV, Damotte D, Traverse-Glehen A, Ribrag V, Andre M. Nivolumab with or without vinblastine for first-line treatment of elderly patients with Hodgkin lymphoma and coexisting medical conditions: the Niviniho phase II Lysa study. Haematologica. 2026 May 28. doi: 10.3324/haematol.2025.300166. Online ahead of print.

Drugs

Indications