Adenovirus (AdV), BK virus (BKV), John Cunningham virus (JCV), human herpesvirus 6 (HHV- 6), Epstein-Barr virus (EBV), and cytomegalovirus (CMV) infections and/or disease in patients at high risk for these viruses following allogeneic hematopoietic cell transplant (HCT) or solid organ transplant (SOT). Infections and Infestations
Conditions
Interventions
Participants will be enrolled at sites participating in Allovir-Sponsored PSL clinical trials (Protocol Number AVM-003-HC, Protocol Number P-105-202, Protocol Number P-105-303) and will be followed fo
Sponsors
ICON Clinical Research Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participation in an Allovir-sponsored PSL clinical trial, regardless of treatment assignment (PSL or placebo) and completion status (completion, early discontinuation). 2. Patient received at least one infusion of PSL or placebo. 3. Patient is willing and able to provide written informed consent to participate in the registry, or a parent or legal guardian is willing and able to provide written informed consent and the potential paediatric participant is able to provide assent in a manner approved by the Institutional Review Board/Independent Ethics Committee and local regulations.
Exclusion criteria
Exclusion criteria: Does not meet inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse drug reactions (ADRs) related to PSL at enrolment visit and follow up measured using patient records | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured using patient records: 1. Incidence of clinical infection with viruses targeted by PSL at enrolment visit and follow up 2. Overall mortality at follow up 3. Non-relapse mortality (defined as death without recurrent or progressive disease after transplantation) at follow up | — |
Countries
Belgium, Canada, England, France, Italy, Korea, South, Spain, Sweden, Turkey, United Kingdom, United States of America
Outcome results
None listed