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
6. Study drug(s) information
Product NameAdcetris
CountryUnited States
Substance INN(s)BRENTUXIMAB VEDOTIN
7. Medical conditions to be studied
Medical condition(s)Yes
Hodgkin's disease mixed cellularity refractory
Anaplastic large cell lymphoma T- and null-cell types refractory
8. Population under study
Age
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of patients
Estimated total number of subjects500
Additional information
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.
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
Prospective patient-based data collection
11. Scope of the study
What is the scope of the study?
PASS
Primary scope : PASS
12. Main objective(s)
What is the main objective of the study?
Evaluate the occurrence of SAEs and specified AESIs, both serious and non-serious, in patients actively treated for relapsed or refractory CD30+ HL or relapsed or refractory sALCL in routine practice with brentuximab vedotin.
Identify and describe potential risk factors for peripheral neuropathy in relapsed or refractory sALCL patients treated with brentuximab vedotin.
Are there primary outcomes?Yes
The frequency, intensity and relationship to treatment will be evaluated for all reported serious adverse events (SAEs).
In addition to SAEs overall, the frequency, intensity and relationship to treatment for the following adverse events of special interest (AESI) will be evaluated:
• Peripheral neuropathy
• Neutropenia
• Infections
• Hyperglycaemia
• Hypersensitivity reactions
Are there secondary outcomes?Yes
All dose modifications including dose delays, temporary interruptions and permanent interruptions, and reported reason for change(s) will be summarised, and where possible the effect of modifications on safety will be explored.
13. Study design
What is the design of the study?
Cohort study
Non-randomised clinical trial
Observational, Multicenter, Prospective
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
Patients will remain under follow-up until death, withdrawal of consent, loss of follow-up or study closure, whichever comes first.
15. Data analysis plan
Please provide a brief summary of the analysis method
Frequency and incidence proportion for all reported SAEs and AESI will be reported for patients enrolled and receiving at least one dose of treatment. Incidence rates and 95% confidence interval (CI) will also be reported for select events. Subgroup safety analyses will be performed by indication and other characteristics of interest (e.g., by age at enrolment < 65 or ≥ 65 years, number of treatment cycles). All dose modifications including dose delays, temporary interruptions and permanent interruptions, and reported reason for change(s) will be summarised, and where possible the effect of modifications on safety will be explored.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Not submitted
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
