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Posoleucel for Multi-Virus Prevention Post-HCT
NCT04693637Phase 3
Key facts
- Status
- Completed
- Start
- Jan 2021
- Primary completion
- Jan 2023
- Countries
- 1
- Sponsor
- AlloVir
- Modality
- Native Immune Cells
- Drugs
- posoleucel
- Conditions
- adenovirus infectionBK virus infectioncytomegalovirus infection (CMV)Epstein-Barr virus infectionhuman herpesvirus 6 infection
01
Overview
Phase 3, open-label, single-arm trial of posoleucel in adenovirus infection, BK virus infection, cytomegalovirus infection (CMV) and 3 more, sponsored by AlloVir. Primary endpoint: Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease at Week 14. Started Jan 2021; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Posoleucel
Posoleucel infusion
03
Who it enrols
High-risk allogeneic HCT recipients (≥1 year old) within 15-42 days post-transplant with no evidence of viral infection or asymptomatic infection, and meeting high-risk criteria such as HLA mismatch, haploidentical donor, cord blood source, T cell depletion, or lymphopenia.
04
Endpoints
Primary
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease
Secondary
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Adenovirus (AdV)
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to BKV
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Cytomegalovirus (CMV)
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Epstein-Barr Virus (EBV)
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Human Herpes Virus 6 (HHV-6)
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to John Cunningham Virus (JCV)
Rates of Overall and Non-Relapse Mortality
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