Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(L01XC25) mogamulizumab
mogamulizumab

Medical condition to be studied

Cutaneous T-cell lymphoma
Population studied

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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 primary objective is to assess non-relapse mortality (death without prior relapse or progression) among patients who were either treated with mogamulizumab, (alone as a single agent or in combination with other therapies) within one year prior to alloHCT, or treated with mogamulizumab, (alone as a single agent or in combination with other therapies), within 18 months after alloHCT.

Outcomes

Cumulative incidence of non-relapse death (NRM) at day 100, day 180, 1-year and 2-years: Time to death without evidence of relapse. Relapse is the competing risk. The secondary objectives are to evaluate the cumulative incidence of: acute GVHD by grade, steroid-refractory GVHD, chronic GVHD, GVHD-free survival, critical illness, primary graft failure, potentially immune-mediated adverse events, hepatic veno-occlusive disease and incidence of relapse.

Data analysis plan

Tabulations of summary statistics, graphical presentations, and statistical analyses will be performed using SAS system as validated software. Descriptive statistics (mean, standard deviation SD, median, minimum, and maximum) for continuous variables and frequency distributions and percentages for discrete variables will be utilized.