Efficacy of Brentuximab-Vedotin Combined with PD-1 Inhibitors in Relapsed/Refractory Hodgkin Lymphoma with ASCT Consolidation and Maintenance Therapy: A Phase 2 Clinical Trial.

Approximately 30% of patients with Hodgkin lymphoma experience relapse or are refractory to first-line chemotherapy. For these patients, immunotherapy has emerged as an effective option. Current treatments include anti-CD30 (Brentuximab-Vedotin) and PD-1 inhibitors (Nivolumab or Pembrolizumab), often in combination with Autologous Stem Cell Transplantation (ASCT). This study aims to evaluate clinical outcomes in a cohort of patients with relapsed/refractory Hodgkin lymphoma (R/R HL) undergoing treatment with immunotherapy combined with ASCT. This is an open-label, single-arm clinical trial involving patients diagnosed with R/R HL who were treated with Brentuximab-Vedotin (BV) combined with a PD-1 inhibitor, followed by consolidation with ASCT and maintenance therapy using BV and a PD-1 inhibitor. An intention-to-treat analysis was performed. The primary endpoints were complete remission rate (CRR), progression-free survival (PFS), overall survival (OS), and the occurrence of severe adverse events. Fifteen patients were included in the study (8 men and 7 women). The median age was 27 years, with an interquartile range (IQR) of 23-37 years. The median follow-up period for the entire cohort was 41.3 months. The pre-transplant CRR was 80%, and the PFS was also 80%. OS at the last follow-up was 100%. No severe adverse events were observed. ASCT was performed in 60% of the patients. This treatment strategy demonstrates high OS and PFS with no serious adverse effects, suggesting that it could be a clinically beneficial approach for patients with R/R HL. Further studies are needed to validate these findings in larger cohorts. The study is registered at ClinicalTrials.gov under the identifier NCT05595447.