Efficacy and Tolerability of N-AVD compared to BrECADD in patients with advanced Hodgkin Lymphoma (N-BRAVE)

Condition studied

Hodgkin lymphoma

Investigational medicinal product(s)

Eligibility

Primary endpoint

Complete metabolic response (CMR) rate assessed by PET/CT 6–8 weeks after completion of chemotherapy.

Endpoint detail

Progression-Free Survival (PFS), assessed during the whole study period., Event-Free Survival (EFS), assessed during the whole study period., Quality of life (QoL) assessed using the EORTC QLQ-HL27 questionnaire, evaluated before treatment, after 2 cycles of chemotherapy, at the end of chemotherapy, and at each follow-up visit., Treatment-related morbidity (TRMB), assessed as the frequency of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE), evaluated after each cycle of chemotherapy., Gonadal recovery assessed by follicle-stimulating hormone (FSH) measurement, evaluated 1 year after completion of chemotherapy., Negative residual disease status assessed by circulating tumor DNA (ctDNA) concentration and thymus and activation-regulated chemokine (TARC) concentration, evaluated after 2 chemotherapy cycles and at the end of chemotherapy (at the time of PET assessment)., Overall survival (OS), assessed during the whole study period.