Non-interventional, post-authorization efficacy study to assess the consistency of Breyanzi product quality and clinical outcomes in patients treated for relapsed/refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and follicular lymphoma Grade 3B after 2 or more lines of systemic therapy in the post-marketing setting (CA082-1105)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  BREYANZI
• Medical condition to be studied:
  Follicular lymphoma
• Additional medical condition(s):
  relapsed/refractory diffuse large B-cell lymphoma,primary mediastinal B-cell lymphoma

Population studied

• 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)
• Estimated number of subjects:
  30

Study design details

• Main study objective:
  The aim of this study is to further assess the consistency of Breyanzi product quality measured at the time of release and clinical outcomes in patients treated in the post-marketing setting for R/R DLBCL, PMBCL, and FL3B after 2 or more lines of systemic therapy. These data will contribute to the evaluation of the need for a revision of the finished product specifications.
• Outcomes:
  Overall response rate (ORR) Complete response rate (CRR) Duration of response (DoR) Progression-free survival (PFS) Overall survival (OS) Presence and severity of cytokine release syndrome (CRS) post Breyanzi infusion Presence and severity of neurotoxicity post-Breyanzi infusion
• Data analysis plan:
  The quality attributes of the infused products and corresponding clinical outcomes in patients treated with Breyanzi will be presented using a line listing including both product and patient variables. Additionally, summary tables and graphs will be presented. The Quantile Range method will be adopted to identify any outliers or errors in the data. No imputations will be performed for missing values. In order to describe batch analysis quality data, graphs such as scatter plots and run charts will be used to perform qualitative, visual assessment. The absence of shifts and trends in the graphs will be sufficient to ascertain consistency in product quality. No formal hypothesis testing is planned.