Analysis of the Burden of Cytomegalovirus Infection and Disease in Hematopoietic Stem Cell Transplant Recipients

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Case-series, Database analysis

Study drug and medical condition

• Medical condition to be studied:
  Cytomegalovirus infection

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:
  350

Study design details

• Main study objective:
  To determine the cumulative incidence of CMV infection and CMV-associated disease in CMV seropositive patients with haematological malignancies, following allogeneic stem cell transplantation at the BMT Unit of the Hammersmith Hospital.
• Outcomes:
  Successful information collection on cumulative incidence of CMV infection and CMV-associated disease in CMV seropositive patients with haematological malignancies, following allogeneic stem cell transplantation at the BMT Unit of the Hammersmith Hospital. To estimate -risks for infection/disease, including associations with patient demographics & treatment characteristics -morbidity/mortality associated with CMV reactivation & serious outcomes -cumulative patient morbidity associated with specific CMV treatments & serious outcomes-PCR values & correlation with response to different CMV-specific treatment-healthcare resource utilization
• Data analysis plan:
  Demographics will be compared between identified groups (i.e. reactivated vs non-reactivated, etc.) using the Chi-square test or Fisher exact test for categorical variablesand Mann-Whitney U-test for continuous variables. Probabilities of EFS and OS will be estimated from the time of transplantation using Kaplan-Meier estimates. The occurrence of engraftment, acute and chronic GVHD, NRM, and REL will be calculated using cumulative incidence estimates taking into consideration the competing events, inkeeping with EBMT statistical guidelines. Factors with impact in univariate analyses, will be analyzed in multivariate analyses for their association with NRM, REL, EFS, and OS by Cox regression multivariate analyses, using a backward-stepping procedure.