OBSERVATIONAL COHORT STUDY TO CHARACTERIZE THE SAFETY OF ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANTATION (HCT) FOR PATIENTS WITH CLASSICAL HODGKIN LYMPHOMA (CHL) TREATED WITH NIVOLUMAB

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

• Study drug International non-proprietary name (INN) or common name:
  NIVOLUMAB
• Medical condition to be studied:
  Hodgkin's disease nodular sclerosis stage IV

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)
• Special population of interest:
  Renal impaired

  Hepatic impaired

  Immunocompromised

  Pregnant women
• Estimated number of subjects:
  90

Study design details

• Main study objective:
  To analyze treatment related mortality at 6 months after an allogeneic HCT among patients with cHL who were previously treated with nivolumab, either alone or in combination.
• Outcomes:
  Treatment related mortality, Causes of death, incidence and severity of acute graft versus host disease (GVHD), hyperacute GVHD, febrile syndrome treated with corticosteroids, incidence of sinusoidal obstruction syndrome, interstitial pneumonitis, renal toxicity requiring dialysis, immune-related adverse events, events of special interest, and duration of hospital stay in patients with cHL who were treated with nivolumab, eit
• Data analysis plan:
  The analysis for the primary objective of this study will include patients who fulfill the eligibility criteria and whom received nivolumab prior to the allogeneic HCT. The primary endpoint of treatment related mortality will be calculated using cumulative incidence function.