Utilising QuantiFERON-CMV to personalise CMV management in haemopoietic stem cell transplant patients
| ISRCTN | ISRCTN14657861 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14657861 |
| Integrated Research Application System (IRAS) | 318862 |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust |
| Funder | Addenbrooke's Charitable Trust, Cambridge University Hospitals |
- Submission date
- 13/01/2026
- Registration date
- 15/07/2026
- Last edited
- 16/07/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Human cytomegalovirus (CMV) is a common virus that can cause severe infections in patients with weakened immune systems, such as those who have undergone a haemopoietic stem cell transplant (HSCT). Patients who have undergone an HSCT are at highest risk of CMV disease between 1 and 3 months after transplant. For this reason, all patients have to take a medication called Letermovir to prevent CMV infection for the first 100 days after their transplant. The aim of this study is to investigate the body’s immune response to CMV after transplant using a blood test called QuantiFERON-CMV. This blood test will help us to determine how quickly and how commonly the body’s natural immunity to CMV returns after HSCT. It will also give us an understanding of how soon after a HSCT letermovir, used to prevent CMV, can safely be stopped. In addition, we will be investigating whether we can develop a new blood test to investigate for CMV infection (called a whole blood CMV-specific IFN assay). We will also compare how well this new test works compared to the QuantiFERON-CMV (QF-CMV) test and to the gold standard FluoroSpot assay.
Who can participate?
Patients aged 16 years and over who are due to receive an allogenic haemopoietic stem cell transplant at CUH.
What does the study involve?
The study involves assessing in the context of prophylaxis with letermovir, the prevalence of stable CMV-specific T-cell immune reconstitution, defined as two reactive QF-CMV responses at 6 and 8 weeks after HSCT, and measured by the QuantiFERON-CMV ELISA assay (Qiagen). Participants will follow study procedures as outlined in the protocol, including scheduled visits and data collection.
What are the possible benefits and risks of participating?
There is no guarantee that participants will directly benefit from taking part in this study. Information collected as part of their participation in this study may help contribute to the advancement of medical knowledge and potentially improve the management of CMV infection in HSCT patients.
The risks associated with participating in this study are minimal and are limited to the standard risks associated with having blood drawn, such as discomfort, bruising, or infection at the site of blood collection.
This study has been designed to fit alongside normal patient care and treatment (the standard of care pathway) where possible, but additional clinic visits may need to be scheduled to align with the study sample and data collection time points. Taking part in this study will not disadvantage the participants' standard care in any way.
Where is the study run from?
Addenbrooke's Hospital (UK)
When is the study starting and how long is it expected to run for?
December 2025 to February 2027
Who is funding the study?
Addenbrookes Charitable Trust (ACT) (UK)
Who is the main contact?
Alexandra Azevedo, alex.azevedo@nhs.net
Contact information
Public, Scientific
Addenbrookes Hospital
Cambridge
CB2 0QQ
United Kingdom
| Phone | +44 (0)1223216083 |
|---|---|
| alex.azevedo@nhs.net |
Principal investigator
CCTU-CT theme, S4 block, Addenbrookes Hospital
Cambridge
CB2 0QQ
United Kingdom
| Phone | +44 (0)1223216063 |
|---|---|
| cuh.quic@nhs.net |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Longitudinal study |
| Participant information sheet | 48824_PIS_V1.0_17Dec2024.pdf |
| Scientific title | Utilising QuantiFERON-CMV to personalise CMV management in haemopoietic stem cell transplant patients |
| Study acronym | QuIC |
| Study objectives | Primary objective: To determine, in the context of prophylaxis with letermovir, the prevalence of stable CMV-specific T-cell immune reconstitution. Secondary objectives: 1. Explore the association between stable CMV-specific T-cell immune reconstitution and clinical outcomes (including CMV viraemia, CMV disease, CMV mutation and death) at 12 months 2. Evaluate the cost savings if letermovir is stopped after 8 weeks rather than 100 days in those with stable CMV-specific T-cell immune reconstitution Exploratory objectives: 1. Develop an in-house whole blood CMV-specific IFN𝛾 assay that may be transferable to clinical practice 2. Determine the diagnostic accuracy of the in-house whole blood CMV-specific IFN𝛾 assay compared with the QuantiFERON-CMV ELISA assay (Qiagen) and Fluorospot assay 3. Identify any CMV mutations emerging in the first 52 weeks following allogeneic-HSCTs |
| Ethics approval(s) |
Approved 03/02/2025, Health and Care Research Wales (Floor four, North, Welsh Government Offices, Crown Building, King Edward VII Ave, Cardiff, CF10 3NQ, United Kingdom; +44 (0)29 2023 0457; E. Essex.REC@hra.nhs.uk), ref: 318862 |
| Health condition(s) or problem(s) studied | Allogeneic haemopoietic stem cell transplant |
| Methodology | We plan to recruit 60 evaluable participants who are due to undergo a HSCT at Cambridge University Hospitals NHS Foundation Trust, Addenbrooke’s Hospital, and will follow them up over 12 months following their HSCT. Participants will be evaluated at a baseline visit. Follow-up will occur at 6 weeks, 8 weeks, 12 weeks and 12 months post-transplant, during which all participants will have blood samples collected to test for their immune response to CMV. Participants who develop CMV viraemia disease during the course of follow-up will also be asked by the study team to provide residual clinical samples for CMV sequencing. Participants will reach the end of the study once the 12month FU visit is concluded. |
| Intervention type | Other |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
1. CMV viraemia, disease, mutation and mortality measured using data collected from SoC results recorded in the medical notes at 52 weeks |
| Completion date | 03/02/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. Written informed consent form 2. Aged 16 years old or above 3. Due to undergo an allogeneic-HSCT at Cambridge University Hospitals NHS Foundation Trust Addenbrooke’s Hospital 4. Confirmed determination of donor AND recipient CMV status by serology 5. Due to take Letermovir prophylaxis following the allogeneic-HSCT 6. Willing and able to comply with scheduled visits, treatment plans, sample collections and other study procedures for the duration of the study |
| Key exclusion criteria | 1. Patient is CMV seronegative 2. Patient is in receipt of virus-specific T cell therapy |
| Date of first enrolment | 09/12/2025 |
| Date of final enrolment | 03/02/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Hills Road
Cambridge
CB2 0QQ
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.0 | 17/12/2024 | 16/07/2026 | No | Yes |
| Protocol file | version 1.1 | 23/04/2025 | 16/07/2026 | No | No |
Additional files
- 48824_PIS_V1.0_17Dec2024.pdf
- Participant information sheet
- 48824_Protocol_V1.1_23Apr2025.pdf
- Protocol file
Editorial Notes
19/01/2026: Study's existence confirmed by the HRA.
