BrECADD: A New Standard in Advanced Hodgkin Lymphoma

Introduction

The BrECADD regimen, established in the targeted BEACOPP study, is now being evaluated in the HD21 study as part of a randomized controlled trial. The primary efficacy endpoint of the GHSG HD21 study compares PET2-guided eBEACOPP versus PET2-guided BrECADD for patients aged 18-60 yo with newly diagnosed advanced-stage classical Hodgkin lymphoma (AS-cHL).

HD21 Study Design

The GHSG-HD21 trial is a multicenter, randomized, open-label, phase III study comparing the efficacy and safety of PET2-guided eBEACOPP versus PET2-guided BrECADD in patients with newly diagnosed AS-cHL. The study includes approximately 1,000 patients aged 18-60 years. Patients are randomized 1:1 to receive either eBEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone) or BrECADD (bleomycin, etoposide, cyclophosphamide, doxorubicin, dacarbazine, and dexamethasone).

Study Objectives

The primary objective of the HD21 study is to compare the progression-free survival (PFS) of patients treated with PET2-guided eBEACOPP versus PET2-guided BrECADD. Secondary objectives include the comparison of overall survival (OS), event-free survival (EFS), and response rates between the two treatment arms. The study will also evaluate the safety and tolerability of both regimens.

Significance of the HD21 Study

The HD21 study is expected to provide important data on the efficacy and safety of PET2-guided eBEACOPP versus PET2-guided BrECADD in patients with newly diagnosed AS-cHL. The results of the study could impact the standard of care for this patient population.