Non-interventional, post-authorization safety study (PASS) of patients treated with commercially available liso-cel (lisocabtagene maraleucel) for large B-cell lymphomas (JCAR017-BCM-005)

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:
  750

Study design details

• Main study objective:
  The main objective is to the incidence and severity of selected adverse drug reactions (ADRs), as outlined in the Summary of Product Characteristics (SmPC), in patients treated with liso-cel in the postmarketing setting and to monitor for potential clinically important adverse events (AEs) that have not yet been identified as part of the liso-cel safety profile.
• Outcomes:
  Secondary malignancies Cytokine release syndrome (CRS) all grades Neurotoxicities all grades Prolonged cytopenias Pregnancy outcome Other AEs considered related to liso-cel treatment (Grade ≥ 3, where applicable), Overall response rate (ORR) Complete response rate (CRR) Duration of response (DoR) Progression-free survival (PFS) Overall survival (OS) Time to next treatment (TTNT)
• Data analysis plan:
  Results will be analyzed and reported descriptively and no formal hypothesis testing is intended. Summary statistics will consist of the number and percentage of patients in each category for discrete variables, whereas for continuous variables the sample size, mean, median, standard deviation, minimum, and maximum will be given. For the primary safety endpoints, incidence proportions and incidence rates will be calculated with the appropriate time periods and methods, analyses will be carried out both with and without accounting for competing risks. For the secondary effectiveness endpoints, Kaplan-Meier estimates and curves will be generated.