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)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Post-Authorisation Safety Study (PASS), Multi-center international prospective, observational

Study drug and medical condition

• Name of medicine:
  ADCETRIS
• Medical condition to be studied:
  Hodgkin's disease mixed cellularity refractory

  Anaplastic large cell lymphoma T- and null-cell types refractory

Population studied

• Short description of the study population:
  The study will aim to enrol eligible patients with relapsed or refractory CD30+ HL or sALCL, from up to 115 centers in Europe. It is estimated that approximately 300 patients (at least 50 of whom have a diagnosis of sALCL) will be eligible and agree to participate during the planned approximate52-month (4 years, 4 months) enrolment period of the study. The sample size for this study was based on the need for more information regarding the occurrence of both serious and non-serious AESI, relative to the size of the current safety database. Patients already being treated with brentuximab vedotin at the time of enrolment will be considered to be retrospectively enrolled for purposes of analysis and inclusion in the PASS.; To the extent possible, enrolment of all eligible patients at each site is expected in order to ensure representativeness of the study population.; Inclusion Criteria; To be eligible for enrolment, patients must meet all of the following criteria:; • Age at enrolment ≥ 18 years; • Clinical diagnosis (with histologic confirmation) of relapsed or refractory CD30+ HL or relapsed or refractory sALCL; • Patient is planned to start or is already receiving single agent therapy with brentuximab vedotin as part of routine clinical care; • Willing and able to provide informed consent; ; Exclusion Criteria; Patients meeting ANY of the following criteria are not eligible for participation:; • Concurrent participation in an interventional clinical study; • Patients with primary cutaneous ALCL, unless the disease has transformed to systemic ALCL
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Hodgkin lymphoma, Anaplastic large cell lymphoma (systemic) patients
• Estimated number of subjects:
  311

Study design details

• Main study objective:
  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.
• Outcomes:
  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, 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.
• Data analysis plan:
  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.