A Study of Brentuximab Vedotin in Patients With Hodgkin Lymphoma Unsuitable for Chemotherapy Due to Age, Frailty or Co-morbidity

Summary

An early phase II, single arm, two stage study, to investigate the level of activity, duration of response and tolerability of brentuximab vedotin (SGN-35), as a single agent, utilising a response adapted approach, in older, frailer or co-morbid patients with previously untreated Hodgkin lymphoma. Opened Feb 2014 and will recruit over 18 months. Duration of treatment will be dependent on the patients' response (see schema below) with a maximum of 16 cycles over 48 weeks. At the end of treatment patients will be assessed clinically at 3 months intervals and by CT scan at 15, 18, 24 and 36 months. For those still alive and disease free after 2 years, follow-up will be according to local practice.

Timeline

Start

2014-02

Primary completion

2016-01-14

Completion

2017-10-02

Publications

• Gibb A, Pirrie SJ, Linton K, Warbey V, Paterson K, Davies AJ, Collins GP, Menne T, McKay P, Fields PA, Miall FM, Nagy E, Wheatley K, Reed R, Baricevic-Jones I, Barrington S, Radford J. Results of a UK National Cancer Research Institute Phase II study of brentuximab vedotin using a response-adapted design in the first-line treatment of patients with classical Hodgkin lymphoma unsuitable for chemotherapy due to age, frailty or comorbidity (BREVITY). Br J Haematol. 2021 Apr;193(1):63-71. doi: 10.1111/bjh.17073. Epub 2020 Sep 14.

Drugs

Indications