Clinical effectiveness and safety of CT-P10 in patients with diffuse large B-cell lymphoma: an observational study in Europe

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety 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:
  • 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:
  500

Study design details

• Main study objective:
  To describe the clinical effectiveness of CT-P10 for the treatment of DLBCL.
• Outcomes:
  • OS, defined as the time from index until death from any cause.• PFS, defined as the time from index until the first documented evidence of disease progression or death from any cause. • Summary of best response to CT-P10 • Time to complete or partial response, defined as the time from index until first documentation of complete or partial response by the local investigator. o Any IRR, Any grade 3 or grade 4 IRRs (according to the Common Terminology Criteria for Adverse Events CTCAE version 4), Any other AE (excluding IRR), Any other grade 3 or grade 4 AE (excluding IRR), Any serious adverse event (SAE).o Demographic and clinical characteristics o DLBCL disease characteristicso Treatment patterns
• Data analysis plan:
  For the primary analyses, the time-to-event clinical effectiveness endpoint analyses (OS, PFS, time to complete or partial response) will be displayed descriptively using Kaplan Meier plots from the index event until the date of the event (or censoring, which will occur at the date of the last hospital visit for OS, where patient is lost to follow-up, the date of data collection for OS, where patient is known to be alive, the date of the last hospital visit at which the patient was known to be free from disease progression for PFS, or the date of the last recorded known response for time to complete or partial response. Absolute counts and the percentages of these events will be reported. The proportion of patients assessed as having a best response of complete response, partial response, stable disease or progressive disease within the 12-, 18-, and 30- months post-index based the documented assessment of the local investigator will be presented with 95% CI.