Impact of CMV-Specific Immune Reconstitution at the End of Letermovir Prophylaxis on the Developm… (NCT06814301) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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)
Spain123 participantsStarted 2025-12-01
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
percentage of patients who develop clinically significant CMV infection (CMV-Cs) up to day +200 post-SCT after completing LTV prophylaxis
Timeframe: From enrollment to 200 days post-SCT
Trial details
NCT IDNCT06814301
SponsorMaimónides Biomedical Research Institute of Córdoba