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

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

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
• Anatomical Therapeutic Chemical (ATC) code:
  (L01FX05) brentuximab vedotin

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

Population studied

• Short description of the study population:
  Study subjects were patients with mycosis fungoides or primary cutaneous anaplastic large cell, ; with the presence of the CD30+ antigen in the lymphoma tissue. Eligible patients were male or ; female subjects, aged ≥ 18 years, included in the CTCL Drug Program between October 2020 and ; April 2024 who received treatment according to the Adcetris (brentuximab vedotin) SmPC. There ; was no predefined sample size, and all data entered in the study database were considered for the ; analysis.
• 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

• Study design:
  Prospective, multicenter, observational, open-label study designed
• 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.
• Setting:
  The study is planned to be conducted in approx. 10 sites in Poland. The sites in BV-BALTIC study will be hospitals and clinics administrating BV in the frames of CTCL Drug Program.
• 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.