Cytomegalovirus Cell Mediated ImmunityINMUNOENDNCT06814301
Impact of CMV-Specific Immune Reconstitution at the End of Letermovir Prophylaxis on the Development of Late Cytomegalovirus Infection in Hematopoietic Stem Cell Transplant Recipients (INMUNOEND)
An observational study of Cytomegalovirus Cell Mediated Immunity and Stem Cell Transplantation, Hematopoietic, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
Trial summary
Cytomegalovirus (CMV) infection is a common complication in patients undergoing hematopoietic stem cell transplantation (SCT). Fixed-duration letermovir (LTV) prophylaxis during the first 100 days post-SCT is effective and safe in preventing this infection, although it may be associated with a delay in CMV-specific… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus Cell Mediated Immunity, Stem Cell Transplantation, Hematopoietic
- What is being tested?
- Periodic immunological monitoring of CMV-specific immune reconstitution will be performed using QTF-CMV
- How many people
- 123 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2025to Sep 2027
- How long will I take part?
- 200 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive CMV seropositive patients undergoing allogenic-SCT who receive LTV prophylaxis will be included. These patients will be prospectively evaluated during the first 200 days post-SCT.
Who may be able to join
- Age >18 years.
- CMV seropositivity (positive IgG) in the recipient at the time of SCT.
- First allogeneic hematopoietic stem cell transplant recipient (bone marrow, peripheral blood, or cord blood).
- Within the first 28 days post-SCT at the time of inclusion.
- Indication for LTV prophylaxis within the first 28 days post-transplant up to 100 days post-SCT, according to the criteria established in each center.
Who cannot join
- CMV seronegativity (negative IgG) in the recipient at the time of transplant.
- Previous allogeneic stem cell transplant (patients with a prior autologous transplant are allowed to be included).
- History of CMV disease in the 6 months prior to inclusion.
- Need for preemptive therapy in the month prior to inclusion in the study.
- Received any of the following in the 14 days prior to inclusion: Ganciclovir, valganciclovir, foscarnet, acyclovir (at doses >3200 mg orally per day or >25 mg/kg IV per day), valacyclovir (at doses >3000 mg orally per day), famciclovir (at doses >1500 mg orally per day).
- Received any of the following in the 30 days prior to screening: Cidofovir, CMV hyperimmune immunoglobulin, any CMV antiviral in the investigational phase.
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- Suspected or confirmed hypersensitivity reaction to the LTV formulation or any of its components.
- Severe hepatic insufficiency (defined as Child-Pugh class C).
- History of primary immunodeficiency prior to transplant.
- Participation in a clinical trial involving the administration of CMV vaccines, other investigational CMV drugs, or monoclonal antibodies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of CMV-Specific Immune Reconstitution at the End of Letermovir Prophylaxis on the Development of Late Cytomegalovirus Infection in HSCT Recipients (INMUNOEND): a Protocol for a Prospective, Observational, Multicenter Study
Cytomegalovirus (CMV) infection is a common complication in patients undergoing hematopoietic stem cell transplantation (SCT). Fixed-duration letermovir (LTV) prophylaxis during the first 100 days post-SCT is effective and safe in preventing this infection, although it may be associated with a delay in CMV-specific immune reconstitution. Hence, it is needed a study to evaluate whether the absence of CMV-specific immune reconstitution at the end of LTV prophylaxis is associated with the development of late infection. This could facilitate the individualization of CMV prophylaxis duration in these patients.
Methods and analysis: INMUNOEND is a multicenter, prospective, observational, non-interventional study including CMV seropositive patients undergoing allo-SCT who receive LTV prophylaxis during the first 100 days post-SCT. Immunological and virological monitorization will be conducted until day +200 post-SCT. The primary outcome variable is the percentage of patients who develop clinically significant CMV infection up to day +200 post-SCT after completing LTV prophylaxis. Data collected will include: baseline characteristics of the hematological diseases and comorbidities, variables related to SCT (i.e. engrafment, graft-versus-host disease, use of letermovir and CMV replication) and variables related to CMV-specific immune reconstitution.
- Being tested
- Periodic immunological monitoring of CMV-specific immune reconstitution will be performed using QTF-CMV
- Keywords
- stem cell transplantation, cytomegalovirus, letermovir, prophylaxis, cytomegalovirus immunity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodic immunological monitoring of CMV-specific immune reconstitution will be performed using QTF-CMVDiagnostic test
A first determination will be made pre-HCT, followed by subsequent determinations at +30, +60, +90, +120, +150, +180, and +200 days post-HCT, as well as at the end of prophylaxis with Letermovir
Periodic immunological monitoring of CMV-specific immune reconstitution will be performed using QTF-CMVDiagnostic test
A first determination will be made pre-HCT, followed by subsequent determinations at +30, +60, +90, +120, +150, +180, and +200 days post-HCT, as well as at the end of prophylaxis with LTV
| Study group | Role | What they receive |
|---|---|---|
| patients undergoing allogenic-SCT who receive LTV prophylaxis with letermovir | Not described Receives: Diagnostic Test: Periodic immunological monitoring of CMV-specific immune reconstitution will be performed using QTF-CMV |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients who develop clinically significant CMV infection (CMV-Cs) up to day +200 post-SCT after completing LTV prophylaxis
Measured: From enrollment to 200 days post-SCT
Secondary outcomes (4)
proportion of patients with CMV-specific immune reconstitution at each QTF-CMV measurement point
Measured: From enrollment to 200 days post-SCT
proportion of patients with CMV replication during the 30 days following QTF-CMV testing
Measured: From enrollment to 200 days post-SCT
detection of any CMV replication and maximum copy number (IU/mL) during follow-up
Measured: From enrollment to 200 days post-SCT
percentage of patients without CMV-specific immune reconstitution at the end of LTV prophylaxis
Measured: From enrollment to 200 days post-SCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start1 Dec 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cytomegalovirus Cell Mediated ImmunityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 123 participants (estimated)
- Target duration
- 200 Days
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814301
- Sponsor's protocol ID
- FCO-INM-2024-04
- Acronym
- INMUNOEND
- Status last verified
- Nov 2025
- First submitted
- 3 Feb 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be available after the end of the study
Publications
Caston JJ, Aparicio C, Paez-Vega A, Pozo Lopez L, Garcia E, Martin C, Ruiz-Arabi E, Cuesta-Casas MA, Bermudez-Rodriguez MA, Cerezo-Martin JM, Gonzalez-Sierra PA, Machuca I, Martin Dominguez FM, Saldana-Moreno R, Herrera C, Torre-Cisneros J. Impact of CMV-specific immune reconstitution at the end of letermovir prophylaxis on the development of late cytomegalovirus infection in haematopoietic stem cell transplant recipients (INMUNOEND): a protocol for a prospective, observational, multicentre study. BMJ Open. 2025 Oct 15;15(10):e101289. doi: 10.1136/bmjopen-2025-101289.
PubMed 41093321
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of CMV-Specific Immune Reconstitution at the End of Letermovir Prophylaxis on the Development of Late Cytomegalovirus Infection in HSCT Recipients (INMUNOEND): a Protocol for a Prospective, Observational, Multicenter Study
- ClinicalTrials.gov ID
- NCT06814301
- Acronym / sponsor ID
- INMUNOEND / FCO-INM-2024-04
- Keywords
- stem cell transplantation, cytomegalovirus, letermovir, prophylaxis, cytomegalovirus immunity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 123 participants (estimated)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cytomegalovirus (CMV) infection is a common complication in patients undergoing hematopoietic stem cell transplantation (SCT). Fixed-duration letermovir (LTV) prophylaxis during the first 100 days post-SCT is effective and safe in preventing this infection, although it may be associated with a delay in CMV-specific immune reconstitution. Hence, it is needed a study to evaluate whether the absence of CMV-specific immune reconstitution at the end of LTV prophylaxis is associated with the development of late infection. This could facilitate the individualization of CMV prophylaxis duration in these patients.
Methods and analysis: INMUNOEND is a multicenter, prospective, observational, non-interventional study including CMV seropositive patients undergoing allo-SCT who receive LTV prophylaxis during the first 100 days post-SCT. Immunological and virological monitorization will be conducted until day +200 post-SCT. The primary outcome variable is the percentage of patients who develop clinically significant CMV infection up to day +200 post-SCT after completing LTV prophylaxis. Data collected will include: baseline characteristics of the hematological diseases and comorbidities, variables related to SCT (i.e. engrafment, graft-versus-host disease, use of letermovir and CMV replication) and variables related to CMV-specific immune reconstitution.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 200 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients undergoing allogenic-SCT who receive LTV prophylaxis with letermovir | – | Diagnostic Test: Periodic immunological monitoring of CMV-specific immune reconstitution will be performed using QTF-CMV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive CMV seropositive patients undergoing allogenic-SCT who receive LTV prophylaxis will be included. These patients will be prospectively evaluated during the first 200 days post-SCT.
Key inclusion criteria (5 listed)
- Age >18 years.
- CMV seropositivity (positive IgG) in the recipient at the time of SCT.
- First allogeneic hematopoietic stem cell transplant recipient (bone marrow, peripheral blood, or cord blood).
- Within the first 28 days post-SCT at the time of inclusion.
- Indication for LTV prophylaxis within the first 28 days post-transplant up to 100 days post-SCT, according to the criteria established in each center.
Key exclusion criteria (10 listed)
- CMV seronegativity (negative IgG) in the recipient at the time of transplant.
- Previous allogeneic stem cell transplant (patients with a prior autologous transplant are allowed to be included).
- History of CMV disease in the 6 months prior to inclusion.
- Need for preemptive therapy in the month prior to inclusion in the study.
- Received any of the following in the 14 days prior to inclusion: Ganciclovir, valganciclovir, foscarnet, acyclovir (at doses >3200 mg orally per day or >25 mg/kg IV per day), valacyclovir (at doses >3000 mg orally per day), famciclovir (at doses >1500 mg orally per day).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periodic immunological monitoring of CMV-specific immune reconstitution will be performed using QTF-CMVA first determination will be made pre-HCT, followed by subsequent determinations at +30, +60, +90, +120, +150, +180, and +200 days post-HCT, as well as at the end of prophylaxis with Letermovir | Diagnostic test | patients undergoing allogenic-SCT who receive LTV prophylaxis with letermovir |
| Periodic immunological monitoring of CMV-specific immune reconstitution will be performed using QTF-CMVA first determination will be made pre-HCT, followed by subsequent determinations at +30, +60, +90, +120, +150, +180, and +200 days post-HCT, as well as at the end of prophylaxis with LTV | Diagnostic test | patients undergoing allogenic-SCT who receive LTV prophylaxis with letermovir |
Primary outcome
percentage of patients who develop clinically significant CMV infection (CMV-Cs) up to day +200 post-SCT after completing LTV prophylaxis
Time frame: From enrollment to 200 days post-SCT
4 secondary outcomes
proportion of patients with CMV-specific immune reconstitution at each QTF-CMV measurement point
Time frame: From enrollment to 200 days post-SCT
proportion of patients with CMV replication during the 30 days following QTF-CMV testing
Time frame: From enrollment to 200 days post-SCT
detection of any CMV replication and maximum copy number (IU/mL) during follow-up
Time frame: From enrollment to 200 days post-SCT
percentage of patients without CMV-specific immune reconstitution at the end of LTV prophylaxis
Time frame: From enrollment to 200 days post-SCT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Derived from this study: PubMed 41093321Caston JJ, Aparicio C, Paez-Vega A, Pozo Lopez L, Garcia E, Martin C, Ruiz-Arabi E, Cuesta-Casas MA, Bermudez-Rodriguez MA, Cerezo-Martin JM, Gonzalez-Sierra PA, Machuca I, Martin Dominguez FM, Saldana-Moreno R, Herrera C, Torre-Cisneros J. Impact of CMV-specific immune reconstitution at the end of letermovir prophylaxis on the development of late cytomegalovirus infection in haematopoietic stem cell transplant recipients (INMUNOEND): a protocol for a prospective, observational, multicentre study. BMJ Open. 2025 Oct 15;15(10):e101289. doi: 10.1136/bmjopen-2025-101289.
- Individual participant dataSharing planned: Yes. IPD will be available after the end of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cytomegalovirus Cell Mediated Immunity and Stem Cell Transplantation, Hematopoietic, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of patients who develop clinically significant CMV infection (CMV-Cs) up to day +200 post-SCT after completing LTV prophylaxis (time frame: From enrollment to 200 days post-SCT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06814301, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.