A Multicenter Prospective Phase II Study Evaluating the Efficacy and Safety of PD-1 Inhibitors Maintenance in Patients With Refractory/Relapsed Classical Hodgkin Lymphoma After Autologous Hematopoietic Stem Cell Transplantation
This phase II study is designed to determine the clinical efficacy of PD-1 inhibitors, administered as maintenance therapy after autologous stem cell transplant (autoHCT), in patients with relapsed or refractory (R/R) classical Hodgkin Lymphoma (cHL)
• 18-70 years;
• Diagnosis of r/r cHL with auto-HCT being performed as consolidation of 2 or later therapy lines;
• High-risk cHL (Primary refractoriness after first-line therapy / Relapse after first line therapy within 12 months / PET/CT-positive status at the time of auto-HCT / Late relapse (\> 12 months) with unfavourable prognosis factors (extranodal lesion and/or bulky and/or B-symptoms) / More than one salvage regimen performed)
• Complete or partial response by PET/CT after auto-HSCT
• No evidence of grade 3-4 adverse events (CTCAEs) after auto-HCT at the time of inclusion in the study;
• Achieved recovery of peripheral blood counts after auto-HSCT (white blood cell count\> 1 109/L, absolute neutrophil count\> 0.5 109/L, platelets \> 25 109/L);
• ECOG 0-2; The decision to include patients that do not fulfil the criteria of hight-risk cHL is made in consultation with the PI