The safety and clinical effectiveness of rapid infusion with CT-P10 in patients with non-Hodgkin’s lymphoma or chronic lymphocytic leukaemia: a retrospective non-interventional post-authorisation safety study in Europe (CT-P10 rapid infusion)

Study type

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

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L01XC02) rituximab

  rituximab
• Medical condition to be studied:
  Diffuse large B-cell lymphoma

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  300

Study design details

• Main study objective:
  To describe the incidence of infusion-related reactions (IRR) associated with rapid infusion of CT-P10 in patients with NHL or CLL on day 1 or day 2 after the index event (index event defined as the first rapid infusion of CT-P10, which must have been given as part of the second or a subsequent treatment cycle)
• Outcomes:
  Proportion of patients who experience an IRR* on day 1 or day 2 after the index event.* An IRR is defined as any AE from a pre-defined list occurring on day 1 or day 2 after an infusion of CT-P10. IRRs, grade 3 or grade 4 IRRs, any adverse event (AE), any serious adverse event (SAE), any grade 3 or grade 4 AE, AEs as the primary cause for treatment discontinuation, overall survival (OS), progression free survival (PFS), best response, overall (complete/partial) response rate, time, NHL / CLL treatment patterns, patients’ demographic, clinical, and NHL/CLL disease characteristics
• Data analysis plan:
  For the primary endpoint analyses, the frequency and proportion of patients receiving CT-P10 who experience IRRs on day 1 or day 2 after the index event will be presented with 95% CI. The proportional Z-test will be used to compare the IRR rate observed in this study with rates previously reported for reference rituximab in the literature.