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Study on Letermovir for Preventing Cytomegalovirus in Stem Cell Transplant Patients with CMV-Positive Donors

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the prevention of Cytomegalovirus (CMV) infection in patients who have received an allogeneic stem cell transplant. This type of transplant involves using stem cells from a donor. The study is particularly interested in patients who are CMV-negative, meaning they have not been previously infected with CMV, and who receive stem cells from a CMV-positive donor. The treatment being tested in this study is a medication called Letermovir, also known by its code name MK-8228. Letermovir is provided in the form of film-coated tablets and is taken orally.

The purpose of the study is to explore how effective Letermovir is in preventing CMV infection in these specific transplant patients. Participants in the study will take Letermovir for a period of up to 14 weeks. During this time, the study will monitor the occurrence of CMV infection and any need for additional treatment. The study will also observe other health outcomes, such as the recovery of blood cells and any side effects related to the medication.

Throughout the study, participants will be regularly checked by healthcare professionals to ensure their safety and to gather information on how well Letermovir works in preventing CMV infection. The study aims to provide valuable insights into the use of Letermovir for CMV prevention in patients who have undergone an allogeneic stem cell transplant.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, previous transplant history, and CMV serology status.

    Written consent is required to participate in the study.

  2. Step 2

    Medication administration

    The medication letermovir is administered in the form of PREVYMIS 240 mg film-coated tablets.

    The tablets are taken orally as a preventive measure against cytomegalovirus (CMV) infection.

    The administration of the medication continues for a period of 14 weeks.

  3. Step 3

    Monitoring and evaluation

    Regular monitoring is conducted to assess the incidence of CMV infection and the effectiveness of the prophylaxis.

    Evaluations include checking for any adverse events, clinical characteristics, and laboratory tests.

    The study also observes the engraftment of neutrophils and platelets by week 4 and week 14.

  4. Step 4

    Follow-up assessments

    Follow-up assessments are conducted to monitor the incidence of CMV infection and any other infections within 180 days after the transplant.

    The study also tracks the duration and cost of any CMV-antiviral treatment required post-transplant.

  5. Step 5

    Completion of study

    The study concludes with a final assessment of the patient's health status and any long-term effects of the medication.

    The estimated end date for the study is November 4, 2027.

Who can join the trial?

5 criteria

  • Must be **18 years old** or older.
  • Must be undergoing their **first allogeneic hematopoietic cell transplant (HCT)**. This means receiving stem cells from a donor.
  • Before the transplant, the patient must have a **negative test for CMV IgG antibodies**, while the donor must have a **positive test for CMV IgG antibodies**. CMV is a virus, and IgG antibodies are proteins in the blood that show if someone has been exposed to the virus before.
  • Must be able to **provide written consent** and complete the informed consent process. This means agreeing to participate in the study after understanding all the details.
  • Must not have **CMV DNAemia** that requires antiviral treatment within 5 days before starting the study medication. CMV DNAemia means the presence of CMV virus in the blood.

Who cannot join the trial?

4 criteria

  • Patients who have a different type of infection that is not related to **Cytomegalovirus**. Cytomegalovirus is a virus that can cause infections, especially in people with weakened immune systems.
  • Patients who have not received an **allogeneic stem cell transplant**. This is a procedure where a person receives stem cells from a donor to help their body make new blood cells.
  • Patients who are not within the specified age range for the study. The study may have specific age requirements.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Letermovir is a medication used in this clinical trial to prevent cytomegalovirus (CMV) infection. It is given to patients who have received a stem cell transplant from a donor who is CMV positive, while the recipient is CMV negative. The goal of using this medication is to reduce the risk of CMV infection during the critical period after the transplant.

What is already known about the treatment

Letermovir – Letermovir is administered orally or intravenously and is used to prevent cytomegalovirus (CMV) infection in patients who have received an allogeneic stem cell transplant. It is currently recognized in medical literature as a prophylactic treatment for CMV, particularly in patients with CMV-seropositive donors. The main therapeutic indication is to prevent CMV infection in these transplant recipients. Letermovir works by inhibiting the CMV DNA terminase complex, which is essential for viral replication. It is classified pharmacologically as an antiviral medication.

Investigated diseases

Cytomegalovirus Infection in Allogeneic Stem Cell Transplant Recipients – This infection occurs when the cytomegalovirus (CMV), a common virus, affects individuals who have received stem cell transplants from a donor. The virus can remain dormant in the body and reactivate, especially in those with weakened immune systems, such as transplant recipients. In these patients, CMV can cause a range of symptoms, from mild flu-like signs to more severe complications affecting various organs. The progression of the infection can lead to the need for medical intervention if the virus becomes active and symptomatic. Monitoring and managing CMV is crucial in transplant recipients to prevent complications. The infection's impact can vary, requiring careful observation and potential treatment to manage symptoms and prevent further health issues.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516011-24-01Estimated enrolment80 patients

sourced from the EU Clinical Trials Register and site verification

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