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AGMT_BV-NIS

Austrian Brentuximab Vedotin observational study

Synopsis

Short title: AGMT_BV-NIS

Title: Austrian Brentuximab Vedotin observational study

Status: closed

Start: July 2017

Coordinating Investigator: Univ. Prof. Dr. Richard Greil

NIS Number: NIS005961

Number of patients: 100 (planned)

Sponsor: AGMT gemeinnützige GmbH

Link to online CRF

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.

Register
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    • ARIADNE NIS
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    • PTCL Register
Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH
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UID-Nummer: ATU63467108
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