Overview

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

Status:
Completed

Trial end date:
2017-10-02

Target enrollment:

Participant gender:

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.

Phase:

Phase 2

Details

Lead Sponsor:

University of Birmingham

Collaborators:

Leukaemia Lymphoma Research
Millennium Pharmaceuticals, Inc.

Treatments:

Antibodies, Monoclonal
Brentuximab Vedotin