Status: OngoingLast updated on: 09/01/2019
1. Study identification
EU PAS Register NumberEUPAS3583
Official titlePost-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
Study title acronymARROVEN
Study typeOther: Post-Authorisation Safety Study (PASS)
Brief description of the studyThis 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
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 2 (specific obligation of marketing authorisation)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameNA
Centre locationNA
Details of (Primary) lead investigator
Title Dr
Last name Dolin
First name Paul
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?100
Countries in which this study is being conducted
International study

Austria
Denmark
France
Germany
Greece
Ireland
Italy
Netherlands
Slovakia
Spain
Sweden
Switzerland
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed04/09/201204/09/2012
Start date of data collection31/03/201326/06/2013
Start date of data analysis30/09/201530/09/2015
Date of interim report, if expected30/04/201630/03/2016
Date of final study report30/07/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesMillennium Pharmaceuticals Inc.100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Dolin
First name Paul
Address line 1Takeda Pharmaceuticals International
Address line 261 Aldwych 
Address line 3 
CityLondon 
PostcodeWC2B 4AE 
CountryUnited Kingdom
Phone number (incl. country code)442031168000 
Alternative phone number 
Fax number (incl. country code) 
Public Enquiries
Title Ms 
Last name Desmons 
First name Nadine 
Address line 1IQVIA 
Address line 2151-161 Boulevard Victor Hugo 
Address line 3 
City93588 Saint-Ouen Cedex 
Postcode 
CountryFrance 
Phone number (incl. country code)33174882215 
Alternative phone number 
Fax number (incl. country code) 
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