Global registry for long-term follow-up of patients participating in clinical trials with Posoleucel (ALVR105)
Phase 4
- Conditions
- 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
- Registration Number
- ISRCTN31439492
- Lead Sponsor
- ICON Clinical Research Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 500
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
Does not meet inclusion criteria
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of adverse drug reactions (ADRs) related to PSL at enrolment visit and follow up measured using patient records
- Secondary Outcome Measures
Name Time Method Measured using patient records:<br>1. Incidence of clinical infection with viruses targeted by PSL at enrolment visit and follow up<br>2. Overall mortality at follow up<br>3. Non-relapse mortality (defined as death without recurrent or progressive disease after transplantation) at follow up