New scoring system could cut Post-Transplant infections
NCT ID NCT07443501
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a scoring system that uses immune system recovery to decide how long patients should take antiviral medicine after a stem cell transplant. The goal is to prevent a common virus called CMV from causing infection. About 1,114 transplant recipients will take part to see if this approach works better than standard care.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,114 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
For enrolled subjects, at 3 months after transplantation, apply a predictive model incorporating CMV-specific immune reconstitution to evaluate the risk of CMV infection after discontinuation of letermovir. Based on the prediction results, define low-risk, intermediate-risk, and high-risk categories. For low-risk patients, direct discontinuation of letermovir is recommended; for intermediate-risk patients, discontinuation may be considered, but close monitoring of peripheral blood CMV-DNA is required after discontinuation; for high-risk patients, extending letermovir treatment until 200 days after transplantation is recommended.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * (1) Recipients who meet either of the following conditions: 1. CMV IgG-positive recipients undergoing HLA-haploidentical hematopoietic stem cell transplantation (HSCT). 2. CMV IgG-negative recipients receiving a graft from a CMV IgG-positive donor, and who have received letermovir as CMV prophylaxis post-transplant without prior discontinuation. * (2) Plasma CMV-DNA level below the lower limit of detection (local threshold: 400 copies/mL) within 5 days before enrollment. * (3) Age ≥ 18 years. * (4) Ability to provide written informed consent independently. * (5) Negative for HIV, HBV, and HCV. * (6) Written informed consent must be provided before initiation of any study procedure. Consent may be provided by the patient or a legally authorized representative if, in the investigator's judgment, obtaining consent directly from the patient is not in the patient's best medical interest. Exclusion Criteria: * (1) Prior clinical diagnosis of CMV infection, CMV disease, or CMV viremia before enrollment; * (2) Received ganciclovir, valganciclovir, foscarnet, acyclovir (oral dose \>3200 mg daily, or intravenous dose \>25 mg/kg daily), valacyclovir (oral dose \>3000 mg daily), or famciclovir (oral dose \>1500 mg daily) within 7 days before enrollment; * (3) Received the following treatments within 30 days before enrollment: cidofovir, CMV hyperimmune globulin, any experimental anti-CMV therapy or biologics; * (4) Presence of uncontrolled infection, requirement for mechanical ventilation, or hemodynamic instability at enrollment; * (5) Suffering from mental illness or other conditions that prevent compliance with study treatment and monitoring requirements; * (6) Inability or unwillingness to sign the informed consent form; * (7) Other special circumstances deemed ineligible by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Donor cells take on Drug-Resistant viruses in new trial
- New drug may offer safer CMV prevention for kidney transplant patients
- New immune duo shows promise in preventing Post-Transplant infection
- Transplant drug tweak may tame common virus