C25023: Effectiveness and Safety for Re-treatment with Brentuximab-Vedotin (BV) in Patients with Relapsed/Refractory (R/R) CD30+ malignancies: a retrospective medical chart review study in Spain. The BELIEVE 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

• Medical condition to be studied:
  Hodgkin's disease

  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:
  35

Study design details

• Main study objective:
  Primary objective of the study is to assess the effectiveness and safety of re-treatment with Brentuximab-Vedotin in participants with Relapsed/Refractory (R/R) cHL/CTCL, MF and pcALCL, sALCL.
• Outcomes:
  The primary outcomes will assess the overall response rate (ORR) as assessed by investigator based on positron emission tomography/computerized tomography (PET/CT) status, number of participants reporting one or more adverse events (AEs). Secondary outcomes will assess duration of response (DOR) based on PET/CT status, overall survival (OS), percentage of participants with complete response based on PET/CT status, time to clinical response (CR or PR), time to best response, time to treatment failure (TTF).
• Data analysis plan:
  Descriptive statistics will be presented as counts or percentages for discrete variables and as median (interquartile range), mean, standard deviation, or standard error of the mean for quantitative variables. All data will be analyzed for overall sample and for different subgroups: cHL, CTCL and sALCL. Kaplan-Meier curves will be used for time-depending variables as PFS, DOR, TTF and OS.

Documents

Study results

C25023-clinical-study-report-redact.pdf