E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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) |
Infezioni e/o malattie da adenovirus (AdV), virus BK (BKV), virus John Cunningham (JCV), herpesvirus umano 6 (HHV-6), virus di Epstein-Barr (EBV) e citomegalovirus (CMV) in pazienti ad alto rischio per questi virus a seguito di trapianto allogenico di cellule ematopoietiche o trapianto d'organo solido (SOT) |
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E.1.1.1 | Medical condition in easily understood language |
Adenovirus, BK virus, John Cunningham virus, human herpesvirus 6, Epstein-Barr virus, and cytomegalovirus in patients at high risk for these viruses following |
adenovirus, virus BK, virus John Cunningham, herpesvirus umano 6, virus di Epstein-Barr e citomegalovirus in pazienti ad alto rischio per questi virus a seguito di trapianto |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10060931 |
E.1.2 | Term | Adenovirus infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10055181 |
E.1.2 | Term | BK virus infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 22.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10020431 |
E.1.2 | Term | Human herpesvirus 6 infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10015108 |
E.1.2 | Term | Epstein-Barr virus infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10011831 |
E.1.2 | Term | Cytomegalovirus infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10023163 |
E.1.2 | Term | JC virus infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the long-term safety of Posoleucel (PSL). |
Valutare la sicurezza a lungo termine di Posoleucel (PSL). |
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E.2.2 | Secondary objectives of the trial |
To evaluate the long-term effectiveness of PSL. To evaluate rates of overall mortality and non-relapse mortality. |
Valutare l'efficacia a lungo termine di PSL. Valutare i tassi di mortalità complessiva e di mortalità senza recidiva. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
1. Partecipazione alla sperimentazione clinica PSL sponsorizzata da Allovir, a prescindere dall’assegnazione al trattamento (PSL o placebo) e dello stato di completamento (completamento, interruzione anticipata). 2. Il/La paziente ha ricevuto almeno un’infusione di PSL o placebo. 3. Il/La paziente è disposto/a e in grado di fornire il consenso informato scritto a partecipare al registro oppure un parente o tutore è disposto e in grado di fornire il consenso informato scritto e il/la potenziale partecipante pediatrico/a è in grado di fornire l’assenso in una forma approvata dal Comitato di revisione istituzionale/Comitato etico indipendente e dai regolamenti locali. |
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E.4 | Principal exclusion criteria |
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E.5 End points |
E.5.1 | Primary end point(s) |
Incidence of adverse drug reactions (ADRs) related to PSL. |
Incidenza di reazioni avverse alfarmaco (ADR) correlate a PSL |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Enrolment visit, Follow up |
Arruolamento, Follow up |
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E.5.2 | Secondary end point(s) |
1. Incidence of clinical infection with viruses targeted by PSL. 2. Overall mortality. 3. Non-relapse mortality (defined as death without recurrent or progressive disease after transplantation). |
1. Incidenza di infezione clinica con i virus bersaglio di PSL 2. Mortalità complessiva 3. Mortalità senza recidiva (definita come decesso senza malattia ricorrente o progressiva dopo il trapianto) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Enrolment visit, Follow up. 2. Follow-up. 3. Follow-up. |
1. Arruolamento, Follow up. 2. Follow-up. 3. Follow-up. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Health economic resource utilization |
Utilizzo delle risorse economiche per la salute |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Registro globale per il follow-up a lungo termine dei pazienti che partecipano alle sperimentazioni |
Global Registry for Long-Term Follow-up of Patients Participating in Clinical Trials with Posoleucel |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 11 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 41 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
Korea, Republic of |
United States |
France |
Sweden |
Spain |
Italy |
Belgium |
United Kingdom |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 10 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 10 |