Global Registry for Long-Term Follow-up of Patients Participating in Clinical Trials with Posoleucel (ALVR105)

Phase 1

• 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); MedDRA version: 21.1Level: PTClassification code 10060931Term: Adenovirus infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.1Level: PTClassification code 10055181Term: BK virus infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 22.0Level: PTClassification code 10020431Term: Human herpesvirus 6 infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 21.1Level: PTClassification code 10015108Term: Epstein-Barr virus infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.1Level: PTClassification code 10011831Term: Cytomegalovirus infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 21.1Level: PTClassification code 10023163Term: JC virus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2022-000763-45-IT
• Lead Sponsor: AlloVir, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-21
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• 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.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 105

Exclusion Criteria

None

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the long-term safety of Posoleucel (PSL).;Secondary Objective: To evaluate the long-term effectiveness of PSL.<br>To evaluate rates of overall mortality and non-relapse mortality.;Primary end point(s): Incidence of adverse drug reactions (ADRs) related to PSL.;Timepoint(s) of evaluation of this end point: Enrolment visit, Follow up

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Incidence of clinical infection with viruses targeted by PSL.<br>2. Overall mortality.<br>3. Non-relapse mortality (defined as death without recurrent or progressive disease after transplantation).;Timepoint(s) of evaluation of this end point: 1. Enrolment visit, Follow up.<br>2. Follow-up.<br>3. Follow-up.