Global registry for long-term follow-up of patients participating in clinical trials with Posoleucel (ALVR105)
| ISRCTN | ISRCTN31439492 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31439492 |
| EudraCT/CTIS number | 2022-000763-45 |
| IRAS number | 1005578 |
| Secondary identifying numbers | P-105-401, IRAS 1005578, CPMS 51835 |
- Submission date
- 08/06/2022
- Registration date
- 21/09/2022
- Last edited
- 03/11/2023
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
Posoleucel (or ALVR105) is a research medicine that contains T-cells made from healthy human donors to defend patients against specific viruses. The purpose of this registry study is to follow up with children and adult patients who were enrolled in Posoleucel clinical trials, in order to obtain long-term safety, effectiveness, and healthcare utilization information after treatment with Posoleucel or placebo. Recording patient health information over time can help to supplement the original study results and improve the care of patients in the future.
Who can participate?
Patients who previously participated in an Allovir-sponsored PSL clinical trial,
What does the study involve?
Analysis of registry data.
What are the possible benefits and risks of participating?
No registry specific procedures will be performed, thus there are no increased risks related to participation other than potential loss of confidentiality. The Sponsor is dedicated to maintaining confidentiality and privacy of patients. The Investigator is responsible for maintaining confidentiality throughout the registry study.
All data used in the analysis and reporting of this evaluation will be without identifiable reference to the patient. The Sponsor, Institution and all Registry Personnel will comply with applicable data protection and privacy laws, including all applicable General Data Protection Requirements (GDPR).
Where is the study run from?
ICON Clinical Research Ltd (Poland)
When is the study starting and how long is it expected to run for?
June 2022 to October 2027
Who is funding the study?
AlloVir, Inc. (USA)
Who is the main contact?
Dr Renuka Palanicawandar, renuka.palanicawandar@nhs.net
Contact information
Scientific
ul. Grojecka 5
Warszawa
02-019
Poland
| Phone | +44 162 8493 560 |
|---|---|
| ALVRRegistryP-105-401_4690-0012@iconplc.com |
Principal Investigator
Hammersmith Hospital
London
W12 0HS
United Kingdom
| Phone | +44 20 313 8158 |
|---|---|
| renuka.palanicawandar@nhs.net |
Study information
| Study design | Observational registry study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital, Other |
| Study type | Safety |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Global registry for long-term follow-up of posoleucel |
| Study hypothesis | 1. To evaluate the long-term safety of Posoleucel (PSL). 2. To evaluate the long-term effectiveness of PSL. 3. To evaluate rates of overall mortality and non-relapse mortality. |
| Ethics approval(s) | Approved 10/08/2022, Yorkshire & The Humber - Sheffield Research Ethics Committee (HS Blood and Transplant Blood Donor Centre Holland Drive, Newcastle upon Tyne Tyne and Wear, NE2 4NQ, United Kingdom; +44 (0)207 104 8388; sheffield.rec@hra.nhs.uk), ref: 22/YH/0139 |
| Condition | 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). |
| Intervention | 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 for 4 years following their first dose of PSL or placebo in the parent study. Registry data will be entered at enrolment and then at 1 year, 2 years, 3 years, and 4 years after the first dose of PSL or placebo. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Posoleucel |
| Primary outcome measure | Incidence of adverse drug reactions (ADRs) related to PSL at enrolment visit and follow up measured using patient records |
| Secondary outcome measures | 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 |
| Overall study start date | 01/06/2022 |
| Overall study end date | 18/10/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 500 |
| Participant 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. |
| Participant exclusion criteria | Does not meet inclusion criteria |
| Recruitment start date | 10/01/2022 |
| Recruitment end date | 01/10/2027 |
Locations
Countries of recruitment
- Belgium
- Canada
- England
- France
- Italy
- Korea, South
- Spain
- Sweden
- Türkiye
- United Kingdom
- United States of America
Study participating centres
Bristol
BS2 8ED
United Kingdom
Department of Womens Health
250 Euston Road
London
NW1 2PG
United Kingdom
Glasgow
G51 4TF
United Kingdom
Edgbaston
Birmingham
B15 2TH
United Kingdom
Praed Street
London
W2 1NY
United Kingdom
Glasgow
G51 4TF
United Kingdom
Ladywood
Birmingham
B16 8ET
United Kingdom
Denmark Hill
London
SE5 9RS
United Kingdom
Upper Maudlin Street
St Michael's Hill
Bristol
BS2 8BJ
United Kingdom
Sheffield
S10 2TH
United Kingdom
Pendlebury
Swinton
Manchester
M27 4HA
United Kingdom
Du Cane Road
London
W12 0HS
United Kingdom
London
WC1N 3JH
United Kingdom
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
Downs Road
Sutton
SM2 5PT
United Kingdom
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Sponsor information
Industry
ul. Grojecka 5
Warszawa
02-019
Poland
| Phone | +48 224 453 029 |
|---|---|
| ALVRRegistryP-105-401_4690-0012@iconplc.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 18/10/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Peer reviewed scientific journals Internal report Conference presentation Publication on website Other publication Submission to regulatory authorities Sharing of results will take place with other researchers. We want to maximise and respect the contributions of participants. Participants will also be able to contact their study doctor if wanting to learn about the results of the study. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
03/11/2023: The following changes were made to the study record:
1. Ethics approval details added.
2. The recruitment start date was changed from 06/01/2022 to 10/01/2022.
3. South Korea, Turkey and USA were added to the countries of recruitment.
4. Addenbrookes was added to the study participating centres.
03/10/2022: Internal review.
08/06/2022: Trial's existence confirmed by NHS HRA.
