Austrian Brentuximab Vedotin observational study
AGMT_BV-NIS
Synopsis
Short title: AGMT_BV-NIS
Title: Austrian Brentuximab Vedotin observational study
Status: open
Start: July 2017
Coordinating Investigator: Univ. Prof. Dr. Richard Greil
NIS Number: NIS005961
Number of patients: 100 (planned)
Sponsor: AGMT gemeinnützige GmbH
Design
This non-interventional clinical study (NIS) is a prospective and retrospective, observational, multi-center research initiative. Data is collected from all sites in Austria willing to participate.
100 patients in 5 years are planned. According to the Austrian office of statistic (Statistik Austria) this would be about 50% of the patients that qualify for BV treatment in this period.
To maintain patient confidentiality, each patient is assigned a unique patient identifying number upon enrolment; this number will accompany the patient’s medical and other information throughout the lifetime of the study.
Objectives:
The objective of this study is to evaluate the use, efficacy and toxicity of Brentuximab vedotin (BV) in Hodgkin´s disease (HD) and systemic anaplastic large cell lymphoma sALCL according to WHO 2008 in Austria and to identify the duration of therapy in these indications.
Further objectives are the evaluation of Progression free and Overall Survival (PFS and OS).
Inclusion/Exclusion criteria
Inclusion criteria (selected):
Physicians select appropriate patients for enrolment. Appropriate patients:
- Patients with Hodgkin’s disease and PTCL (sub-entity sALCL) (according to the WHO 2008 classification) who are willing to partici-pate and receive or qualify for BV therapy
Due to the non-interventional design of the registry there are no specific inclusion or exclusion criteria.