Blood test could tailor CMV prevention after stem cell transplants
NCT ID NCT06453460
First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether a blood test that measures CMV-specific immunity (CMV-TCIP) can help doctors decide how long to continue the antiviral drug letermovir after an allogeneic stem cell transplant. Participants receive letermovir for 14 weeks, then the test guides whether to extend prophylaxis. The goal is to prevent clinically significant CMV infection within the first year after transplant.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- letermovir, a drug to prevent CMV infection, and a CMV immunity blood test (CMV-TCIP) to guide treatment duration
- What this could lead to
- If successful, this approach could reduce CMV infections after stem cell transplant while avoiding unnecessary prolonged medication.
- What could go wrong
- This is a small, early-phase trial, so results may not apply to all patients. The blood test may not accurately predict infection risk.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2024
- Expected to finish
-
Jun 2029
An estimate. End dates often move.
- Lead sponsor
-
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.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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: * ≥ 18 years of age on the day of signing informed consent. * Karnofsky performance \>70% * Have documented seropositivity for CMV (either donor or recipient CMV IgG seropositivity) before AHCT. * Eligible for AHCT from an HLA-matched related, matched unrelated, mismatched unrelated or haploidentical donor using either bone marrow or peripheral blood stem cells. * Have undetectable CMV DNA from a plasma sample collected within 5 days prior to enrollment. * Must be within Day-10 thru Day+28 days of planned HSCT at the time of enrollment. * Be able to comply with medical recommendations or follow-up. * Has adequate organ functions determined by 1. Serum creatinine clearance ≥50 ml/min (calculated with Cockroft-Gault formula). 2. Bilirubin ≤1.5 mg/dl except for Gilbert's disease. 3. ALT or AST ≤200 IU/ml for adults. 4. Conjugated (direct) bilirubin \< 2x upper limit of normal. 5. Left ventricular ejection fraction ≥40%. 6. Diffusing capacity for carbon monoxide (DLCO) ≥ 50% predicted corrected for hemoglobin. Exclusion Criteria: * Has a history of CMV end-organ disease or CS-CMVi within 6 months prior to enrollment. * Received within 7 days prior to screening or plans to receive during the study any of the following: 1. Ganciclovir 2. Valganciclovir 3. Foscarnet 4. Acyclovir (\> 3200 mg PO per day or \> 25 mg/kg IV per day) 5. Valacyclovir (\> 3000 mg/day) 6. Famciclovir (\> 1500 mg/day) * Received within 30 days prior to screening or plans to receive during the study any of the following drugs: cidofovir, CMV hyper-immune globulin, any investigational CMV antiviral agent/biologic therapy. * Has suspected or known hypersensitivity to active or inactive ingredients of letermovir formulations. * Has an uncontrolled infection * Requires mechanical ventilation or is hemodynamically unstable
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Allogeneic stem cell transplantation are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
-
Contact
Email: •••••@•••••
Locations
-
Chao Family Comprehensive Cancer Center, University of California Irvine
RECRUITINGOrange, California, 92868, United States
Contact Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can an antiviral drug protect hearing in infants with congenital CMV?
- Can cord blood t cells be trained to stop viral infections after transplant?
- Can a new IV antiviral tame two stubborn viruses?
- A new drug combo may shield kidney transplant patients from a common viral threat
- Can 'Supercharged' donor cells beat viruses that drugs Can't?
- Banked immune cells show promise against Life-Threatening viruses in transplant patients