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Immune test could personalize CMV prevention in transplant patients

NCT ID NCT06449586

Disease control Sponsor: Ruijin Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a CMV-specific T cell immunity test can help doctors decide how long to give letermovir to prevent late CMV infection after a stem cell transplant. About 250 adults with blood cancers who had a first transplant will take part. The goal is to see if using the test reduces late CMV infections compared to standard care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Letermovir
What this could lead to
If successful, this could show that using an immunity test to personalize letermovir treatment reduces late CMV infections after stem cell transplants.
What could go wrong
This is a Phase 3 trial, but it is still early to know if the approach works better than standard care. The test may not accurately predict infection risk for all patients.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Jun 2026

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 to 70 years

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * first allogeneic hematopoietic stem cell transplantation; * 18-70 years old; * use cytomegalovirus prophylaxis with letemovir after allo-HSCT; * CMV Ig G D+/R+; Exclusion Criteria: * Allergy, known hypersensitivity to letermovir tablet or injection components; * CMV DNAemia within six months before transplantation or previous CMV disease; * Presence of organ failure and inability to tolerate allogeneic hematopoietic stem cell transplantation; * Second transplantation; * Combination of immunodeficiency diseases; * Those judged by the investigator to be unsuitable for participation in this trial.

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Conditions

The condition(s) this trial relates to.

hematopoietic and lymphoid cell neoplasm hematopoietic and lymphoid system neoplasm cytomegalovirus infection prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hematologic malignancy

Contacts and locations

Locations

  • Ruijin Hospital of Shanghai Jiaotong University

    Shanghai, Shanghai Municipality, China

  • Ruijin Hospital, Shanghai JiaoTong University School of Medicine

    Shanghai, China

  • Shanghai Liquan Hospital

    Shanghai, China

  • The First Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, China

  • Tongji Hospital of Huazhong University of Science and Technology, Wuhan

    Wuhan, Hubei, China

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