A Phase Ii Study Of Brentuximab Vedotin (Bv) In The Treatment Of Elderly Hodgkin Lymphoma (Hl) Patients At First Relapse Or With Primary Refractory Disease - Fil_bvhd01

Older age (≥60 years) has consistently been identified as an independent adverse prognostic factor for Hodgkin lymphoma (HL) survival in population-based studies and clinical trials in the last several decades. Elderly HL patients are significantly underrepresented in clinical trials and have a markedly inferior prognosis compared with younger patients. Brentuximab vedotin (BV) is an antibody-drug conjugate linking the microtubule-disrupting agent monomethylauristatin E to an anti-CD30 antibody. BV monotherapy yields an objective response rate (ORR) of 75% in relapsed HL, with a subset of patients having durable remissions at 5 years. In a retrospective analysis of BV activity in patients aged ≥60 years with relapsed HL, ORR was 56%. Although higher rates of adverse events (AEs) such as anemia, fatigue, and neuropathy were seen in older compared with younger patients, BV was tolerable overall, and a significant proportion of older patients had clinical benefit. Based upon this favorable experience, our phase II study evaluated the efficacy and safety of BV as a single agent in elderly patients at first relapse or with primary refractory HL. This was a single-arm, open-label, multicenter, clinical trial. The primary endpoint of this study was the ORR. Main secondary endpoints were: duration of response, complete remission rate, progression free and overall survival at 1 year and type, incidence, severity, seriousness, and relatedness of any adverse events occurring during the study period. ClinicalTrials.gov identifier NCT02227433.