Brentuximab-5014: Brentuximab Vedotin Administration Registry and Outcomes Study in Polish CTCL Patients (BV-BALTIC study)

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

• Study drug International non-proprietary name (INN) or common name:
  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:
  60

Study design details

• Main study objective:
  The primary objective of the study is to determine objective skin response which lasted 4 months or longer (sORR4) measured by modified severity weighted assessment form (mSWAT) and to measure best overall skin response, (Best overall skin response rate BsORR) measured by mSWAT.
• Outcomes:
  The primary endpoint is percentage of patients with sORR4 measured by mSWAT, complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) as best response at any time between initiation and cessation of the treatment, and incidence rate of adverse events and serious adverse events. The secondary endpoint is progression free survival and duration of response.
• Data analysis plan:
  Data will be summarized using standard descriptive statistics. For primary and secondary endpoints percentages will be calculated and presented with 95 percent (%) confidence intervals. For secondary endpoints survival analysis using Kaplan-Meier method will be used. Subgroups will be compared using appropriate statistical tests: Chi-square or Fisher test (for categorical data), Two-sample t-test or U Mann-Whitney test for numeric data.