Evaluation of a laboratory test called QuantiFERON Cytomegalovirus in allogeneic stem cells transplant patients to assess its ability to detect the timing when the patients' immune system can control cytomegalovirus infection, thus allowing the clinical team the discontinuation of antiviral prophylaxis

Evaluation of the clinical usefulness of QuantiFERON®-CMV assay in identifying when patients reconstitute their immunity against cytomegalovirus (CMV) after undergoing allogeneic HSCT: a prospective, non-randomised, open-label study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13577788

Enrollment

Registered

2025-07-14

Start date

2024-02-25

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cytomegalovirus immune reconstitution in recipients of allogeneic haematopoietic stem cell transplant Infections and Infestations

Interventions

The study aims to measure CMV-specific CD8+ lymphocyte function post-allogeneic-HSCT by using the QuantiFERON®-CMV assay on the DiaSorin Liaison XL Chemiluminescent diagnostic platform located in the

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18 years and over 2. Male or female 3. CMV IgG positive HSCT recipients, irrespective of the donor’s CMV IgG status 4. CMV IgG negative HSCT recipients with a CMV IgG positive donor

Exclusion criteria

Exclusion criteria: 1. CMV IgG negative HSCT recipient with a CMV IgG negative donor 2. Absence/withdrawal of consent

Design outcomes

Primary

Measure	Time frame
1. Risk of CMV disease is measured using the QuantiFERON-CMV assay on the DiaSorin Liaison XL platform at baseline (hospital admission before conditioning), and monthly until day 180 post-allogeneic-HSCT 2. IFN-gamma production in IU/mL is measured using the QuantiFERON-CMV assay at baseline and monthly until day 180 post-allogeneic-HSCT 3. Presence of CMV-specific CD8+ cells is measured using flow cytometry for CD3, CD4, CD8, CX3CR1, CCR7, and CD45RA at baseline and monthly until day 180 post-allogeneic-HSCT	—

Measure

Time frame

1. Risk of CMV disease is measured using the QuantiFERON-CMV assay on the DiaSorin Liaison XL platform at baseline (hospital admission before conditioning), and monthly until day 180 post-allogeneic-HSCT 2. IFN-gamma production in IU/mL is measured using the QuantiFERON-CMV assay at baseline and monthly until day 180 post-allogeneic-HSCT 3. Presence of CMV-specific CD8+ cells is measured using flow cytometry for CD3, CD4, CD8, CX3CR1, CCR7, and CD45RA at baseline and monthly until day 180 post-allogeneic-HSCT

—

Secondary

Measure	Time frame
1. CMV immune reactivity is measured using the QuantiFERON-CMV assay at baseline and monthly until day 180 post-allogeneic-HSCT 2. CMV viral load is measured using weekly CMV DNA PCR testing from blood samples as part of standard of care from baseline until day 180 post-allogeneic-HSCT 3. CMV-specific CD8+ cell immunity is measured using the QuantiFERON-CMV assay at baseline and monthly until day 180 post-allogeneic-HSCT 4. Change in CMV viral load following reactivation is measured using CMV DNA PCR testing at the time of reactivation and in a follow-up blood sample collected 48–72 hours later	—

Measure

Time frame

1. CMV immune reactivity is measured using the QuantiFERON-CMV assay at baseline and monthly until day 180 post-allogeneic-HSCT 2. CMV viral load is measured using weekly CMV DNA PCR testing from blood samples as part of standard of care from baseline until day 180 post-allogeneic-HSCT 3. CMV-specific CD8+ cell immunity is measured using the QuantiFERON-CMV assay at baseline and monthly until day 180 post-allogeneic-HSCT 4. Change in CMV viral load following reactivation is measured using CMV DNA PCR testing at the time of reactivation and in a follow-up blood sample collected 48–72 hours later

—

Countries

England, United Kingdom

Contacts

Public ContactEmanuela Pelosi

Emanuela.Pelosi@uhs.nhs.uk+44 (0)2381205101

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026