Study identification

EU PAS number

EUPAS3583

Study ID

42799

Official title and acronym

Post-Authorisation Safety Study (PASS) MA25101: An Observational Cohort Study of the Safety of Brentuximab Vedotin in the Treatment of Relapsed or Refractory CD30+ Hodgkin Lymphoma and Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma (ARROVEN)

DARWIN EU® study

No

Study countries

Austria
Belgium
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Ireland
Italy
Latvia
Lithuania
Netherlands
Norway
Poland
Portugal
Slovakia
Slovenia
Spain
Sweden
Switzerland
United Kingdom

Study description

This study is a Post Approval Safety Study (PASS) mandated by the European Medicines Agency. This is a multi-centre prospective, observational cohort study of the safety of brentuximab vedotin treatment in patients who have been diagnosed with relapsed or refractory CD30+ Hodgkin Lymphoma (HL) or relapsed or refractory Systemic Anaplastic Large Cell Lymphoma (sALCL). The study will target the enrolment of approximately 300 patients (at least 50 of whom have a diagnosis of sALCL), who will be treated or are being treated with brentuximab vedotin at approximately 75-100 sites in Europe and potentially other countries outside of Europe. Patients will be enrolled over a 3-year enrolment period and the total study duration will be five years from the date of first patient enrolled. The objectives of the study are to: 1. Evaluate the occurrence of Serious Adverse Events (SAEs) and specified adverse events of special interest (AESI), both serious and non-serious, in patients actively treated for relapsed or refractory CD30+ Hodgkin Lymphoma and Relapsed or Refractory sALCL in routine practice with brentuximab vedotin 2. Identify and describe potential risk factors for peripheral neuropathy in relapsed or refractory CD30+ Hodgkin Lymphoma or Relapsed or Refractory sALCL patients treated with brentuximab vedotin

Study status

Finalised
Research institutions and networks

Institutions

Multiple centres: 100 centres are involved in the study

Contact details

Linton Kim

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Millennium Pharmaceuticals Inc.
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 2 (specific obligation of marketing authorisation)