An observational study in CMV Infection and Hematopoietic Stem Cell Transplantation, sponsored by The First Affiliated Hospital of Soochow University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-19.
Sponsored by The First Affiliated Hospital of Soochow University · Observational
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.
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.
362 studies on the registry are indexed under Cytomegalovirus Infections; 59 are open to participants now.
This study's enrollment of 200 is above the median of 150 across 100 observational studies indexed under Cytomegalovirus Infections.
Browse Cytomegalovirus Infections studies →The First Affiliated Hospital of Soochow University is the lead sponsor of 258 studies on the registry; 149 are open to participants now.
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The study consists 200 cases CMV-R+ adult (>18 years) recipients of haplo-HCT. All patients will receive letermovir prophylaxis.
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Exclusion Criteria:
The study consists 200 cases CMV-R+ adult (\>18 years) recipients of haplo-HCT. All patients will receive letermovir prophylaxis. Consider a simple interim analysis of the experimental group could be arranged after 150 patients are enrolled if necessary. Supportive care is provided by institutional standards of care (e.g., acyclovir for herpes simplex virus and varicella zoster virus prevention). Letermovir prophylaxis is started on day 0 or no longer than 28 days after transplantation. During the study period, letermovir 480 mg PO/IV once daily (or 240 mg per day in patients taking cyclosporine) was administered from day 0 to day +100 post-HCT. CMV monitoring and preemptive therapy were performed according to local protocol. Plasma CMV viral load (VL) is monitored by quantitative CMV PCR, starting on day +7 and continued weekly until week 6, then every 2-4 weeks for months until week 24.
Drug: Letermovir
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.
Incidence of clinically significant CMV infection
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.
Time frame: at Week 14 following haplo-SCT
Incidence of clinically significant CMV infection
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.
Time frame: through Week 24 following haplo-SCT
Incidence of CMV DNAemia and CMV disease
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.
Time frame: through Week 14 and Week 24 following haplo-SCT
Incidence of the resistant or refractory CMV infection
Resistant or refractory CMV infection occurs if CMV levels rise by 1 log after 2 weeks of treatment or remain positive after 4 weeks.
Time frame: through Week 24 following haplo-SCT
Incidence of serious adverse event leading to interruption of treatment
Serious adverse events refers to events that require stopping the treatment to ensure patient safety.
Time frame: through Week 24 following haplo-SCT
Incidence of CMV-related disease mortality
Death resulting directly or indirectly from complications of a CMV infection, often involving severe organ damage in the lungs, liver, or other organs.
Time frame: through Week 24 following haplo-SCT
Incidence of all-cause mortality and non-relapse mortality
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.
Time frame: through Week 24 following haplo-SCT
Incidence of CMV-associated morbidity
CMV-associated morbidity refers to organ damage, delay engraftment, acute or chronic GVHD occurrence, or other infectious diseases caused by CMV.
Time frame: through Week 24 following haplo-SCT
Incidence of rehospitalization
The frequency or rate at which patients are readmitted to the hospital within a specified period following their discharge.
Time frame: through Week 14, Week 24 following haplo-HSCT
Plan to share: No
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Soochow University →