Real-world Evidence Study on Brentuximab Vedotin Retreatment Outcomes of Cutaneous T-cell Lymphoma Patients (Brentuximab-5020)

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

• Name of medicine:
  ADCETRIS
• Study drug International non-proprietary name (INN) or common name:
  BRENTUXIMAB VEDOTIN
• Anatomical Therapeutic Chemical (ATC) code:
  (L01XC12) brentuximab vedotin

  brentuximab vedotin
• Medical condition to be studied:
  Cutaneous T-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:
  50

Study design details

• Main study objective:
  The main objective of this study is to describe the safety and effectiveness of Brentuximab Vedotin (BV) retreatment in participants with CTCL.
• Outcomes:
  - Objective Response Rate (ORR) ; - Progression Free Survival (PFS) ; - Time to Next Treatment (TTNT); - Incidence & Grading of Motor Neuropathy ; - Time to Improvement & Resolution of Motor ; - Neuropathy Incidence & Grading of Sensory Neuropathy ; - Time to Improvement & Resolution of Sensory Neuropathy ; - Incidence & Grading of Neutropenia ; - Incidence & Grading of Febrile Neutropenia ; - Incidence & Grading of Serious Infections, ; - Number of Participants With Cutaneous Lymphoma Co-Medications or Strategies Used to Treat CTCL Disease --; - Number of Cycles of BV Administered Time Interval Between BV Administration
• Data analysis plan:
  The summary tables with measures of central tendency and standard deviation for continuous variables and frequency distributions would be presented as a part of the descriptive analysis. Main results would consist of summary across countries, with subgroup analysis stratified by variables of interest performed based on number of participants in each subgroup. There would be a summarization of participants characteristics, treatment patterns and outcomes. To understand the association between participants' characteristics and study outcomes Univariate and Multivariate regression analyses would be performed. Kaplan-Meier survival analysis with 95% will be presented.