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Completed

NCT Number: NCT05789615

Letermovir Prophylaxis for CMV Infection in Haplo-HSCT Recipients: Single-center Data in China

In the 30 years of fighting CMV infection, the mortality rate among HSCT patients has significantly reduced. Now, the focus is on improving the prognosis of HSCT patients and preventing CMV infection. The emergence of letermovir has provided a new opportunity in this regard. Letermovir, the only drug approved for CMV infection prevention in HSCT patients, works by inhibiting the CMV DNA terminase complex. Phase III studies have shown that letermovir significantly reduces CMV infection and all-cause mortality after HSCT, without increasing myelosuppression or nephrotoxicity. Real-world studies have further confirmed its efficacy in reducing CMV infection rates and antiviral use. Letermovir's global success has not yet been fully realized in China, where it is still in its early stages of use.

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Key information

Conditions

CMV Infection Cytomegalovirus Infections DNA Virus Infections Hematopoietic Stem Cell Transplantation Herpesviridae Infections Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Soochow university

Suzhou, Jiangsu, China

About this study

Letermovir achieved excellent therapeutic outcomes globally but is still developing in China. It received an implied license for clinical trials in June 2020, followed by marketing applications in November 2020. In December 2021, it was approved by the China National Medical Products Administration (NMPA) for preventing CMV infection and disease in CMV seropositive adult recipients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). Letermovir's commercial launch in China is expected in August 2022. Given that over 90% of the Chinese population is CMV seropositive, determining whether CMV prevention is necessary based solely on serology is insufficient. The growing use of haploidentical stem cell transplantation (haplo-SCT) in China, particularly using the Beijing protocol for GVHD prevention, increases CMV risk. However, limited data exists on the efficacy of CMV prophylaxis for haplo-SCT patients in China. A real-life study assessing the efficacy, resistance, and tolerability of letermovir in this patient group is essential to guide CMV management strategies, particularly for high-risk CMV R+ haploidentical transplant recipients. This prospective study aims to evaluate letermovir's real-life impact on efficacy, resistance, tolerability, and CMV-related morbidity and mortality in China.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Haplo-SCT candidate (adult) who has decided to primary transplant and is willing to participate in the study.
  • The haplo-SCT candidate (adult) should be CMV seropositive recipients.

Exclusion criteria

  • CMV-seronegative patient receiving a negative CMV donor graft.
  • Patients having active CMV DNAemia at the time of letermovir initiation.
  • Patient having signed the informed consent but not grafted.
  • Patient recruited in a clinical study on an anti-CMV trial.

Treatment and study plan

Letermovir

Drug

Letermovir has achieved excellent therapeutic benefits globally but is still in its infancy in China. Letermovir obtained an implied license for a clinical trial in June 2020, and in November 2020, Letermovir submitted and accepted four new drug marketing applications in China, including injection and tablet formulations. On December 31, 2021, the China National Medical Products Administration (NMPA) approved letermovir for cytomegalovirus (CMV) seropositive adult recipients undergoing allogeneic hematopoietic stem cell transplantation (HSCT) [R+] prevention of cytomegalovirus infection and cytomegalovirus disease. The commercial launch of letermovir is estimated to be in August 2022.

Primary outcomes

  1. Incidence of clinically significant CMV infection

    Time frame: at Week 14 following haplo-SCT

    Defined as CMV DNAemia leading to preemptive treatment or presence of CMV disease using classificatory criteria published by the Disease Definitions Working Group of the Cytomegalovirus Drug Development Forum. CMV DNA threshold for initiation of preemptive therapy at our center is viral load >500 copies/mL or above on two consecutive tests.

Secondary outcomes

  1. Incidence of clinically significant CMV infection

    Time frame: through Week 24 following haplo-SCT

    Defined as CMV DNAemia leading to preemptive treatment or presence of CMV disease using classificatory criteria published by the Disease Definitions Working Group of the Cytomegalovirus Drug Development Forum. CMV DNA threshold for initiation of preemptive therapy at our center is viral load >500 copies/mL or above on two consecutive tests.

  2. Incidence of CMV DNAemia and CMV disease

    Time frame: through Week 14 and Week 24 following haplo-SCT

    CMV DNAemia refers to the presence of CMV DNA in the blood. CMV disease refers to the organ dysfunction caused by an active CMV infection, such as the lungs, liver, and retina.

  3. Incidence of the resistant or refractory CMV infection

    Time frame: through Week 24 following haplo-SCT

    Resistant or refractory CMV infection occurs if CMV levels rise by 1 log after 2 weeks of treatment or remain positive after 4 weeks.

  4. Incidence of serious adverse event leading to interruption of treatment

    Time frame: through Week 24 following haplo-SCT

    Serious adverse events refers to events that require stopping the treatment to ensure patient safety.

  5. Incidence of CMV-related disease mortality

    Time frame: through Week 24 following haplo-SCT

    Death resulting directly or indirectly from complications of a CMV infection, often involving severe organ damage in the lungs, liver, or other organs.

  6. Incidence of all-cause mortality and non-relapse mortality

    Time frame: through Week 24 following haplo-SCT

    All-cause mortality refers to deaths from any cause, while non-relapse mortality refers to deaths caused by factors other than the recurrence or relapse of the original disease or condition.

  7. Incidence of CMV-associated morbidity

    Time frame: through Week 24 following haplo-SCT

    CMV-associated morbidity refers to organ damage, delay engraftment, acute or chronic GVHD occurrence, or other infectious diseases caused by CMV.

  8. Incidence of rehospitalization

    Time frame: through Week 14, Week 24 following haplo-HSCT

    The frequency or rate at which patients are readmitted to the hospital within a specified period following their discharge.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Soochow University

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

Letermovir Prophylaxis for Cytomegalovirus Infection in Haploidentical Allogeneic Hematopoietic Cell Transplant Recipients: Single-center Real-world Data in China

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 29, 2023
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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