A multicenter, prospective, cohort study to investigate the incidence and clinical management of CMV infection in adult patients with hematological malignancies following allogeneic hematopoietic stem cell transplantation in China

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

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:
  482

Study design details

• Main study objective:
  To determine the incidence of clinically significant CMV infection through Week 24 following allo-HSCT.
• Outcomes:
  Variables to collect for outcomes of interest include clinical outcomes following the allo-HSCT, particularly focusing on the incidence and clinical management for CMV infection.
• Data analysis plan:
  Addressing primary and secondary objectives will be based on descriptive analysis. Subgroup analysis will be performed by pre-specified covariates. Changes of non-confirmatory analyses made after the protocol has been finalized, along with an explanation as to when and why they occurred, will be listed in the clinical study report (CSR) for the study. Post hoc exploratory analyses will be clearly identified in the CSR. The study does not plan to generate any association/casual inference between antiviral drug and CMV infection. The study analysis will not link any safety information to an antiviral drug (including a Merck product) or an antiviral drug class (containing a Merck product). A separate statistical analysis plan (SAP) may be created for this study and finalized before the end of data collection and database lock.