Status: OngoingLast updated on: 04/02/2014
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+ HL or relapsed or refractory sALCL. The study will target the enrolment of approximately 500 patients (at least 50 of whom have a diagnosis of sALCL), who will be 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)?
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 Ms
Last name Cellauro
First name Francesca
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
Czech Republic
Denmark
France
Germany
Italy
Netherlands
Norway
Slovakia
Slovenia
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 collection30/06/201326/06/2013
Start date of data analysis01/09/2015
Date of interim report, if expected01/04/2016
Date of final study report01/12/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesMillennium Pharmaceutical Inc.100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Ms
Last name Cellauro
First name Francesca
Address line 1Quintiles
Address line 2Chemin du Glapin 6 
Address line 3 
CitySt-Prex 
Postcode1162 
CountrySwitzerland
Phone number (incl. country code)39051363098 
Alternative phone number 
Fax number (incl. country code)39051363098 
Public Enquiries
Title Ms 
Last name Cellauro 
First name Francesca 
Address line 1Quintiles 
Address line 2Chemin du Glapin 6 
Address line 3 
CitySt-Prex 
Postcode1162 
CountrySwitzerland 
Phone number (incl. country code)39051363098 
Alternative phone number 
Fax number (incl. country code)39051363098 
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