Post-authorisation safety study of allogeneic haematopoietic cell transplantation in patients treated with mogamulizumab

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• If ‘other’, further details on the scope of the study:
  Post-Authorisation Safety Study

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  MOGAMULIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01FX09) 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 of the study is to assess treatment-related mortality and 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:
  Primary: Cumulative incidence of treatment-related death and 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.; ; Secondary: Cumulative incidence of acute GVHD, severe acute GVHD, steroid-refractory acute GVHD, hyperacute GVHD, chronic GVHD, steroid-refractory chronic GVHD, GVHD-free survival, critical illness, primary graft failure, potentially immune-medicated adverse events, hepatic veno-occlusive disease and relapse. Evaluating progression-free survival, overall survival, cause of death and time to neutrophil and platelet recovery.; ; Exploratory: Exploring probability of non-relapse mortality and acute GVHD after alloHCT by duration between treatment with mogamulizumab (prior to and post) alloHCT.
• 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.