Letermovir Prophylaxis Duration Guided by CMV-Specific T-cell Monitoring After Allo-HSCT.
A Multicenter, Randomized, Controlled, Open-label Clinical Study to Evaluate the Efficacy and Safety of Letermovir Prophylaxis Duration Guided by Dynamic Monitoring of Specific T-cells for Preventing Cytomegalovirus Infection in Adult Recipients of Allogeneic Hematopoietic Stem Cell Transplantation in China.
The purpose of this study is to evaluate the efficacy and safety of a personalized strategy for discontinuing Letermovir (a drug used to prevent Cytomegalovirus [CMV] infection) based on the recovery of the patient's own immune system.
Cytomegalovirus (CMV) is a common and serious complication after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Currently, Letermovir is typically given as a standard prevention for about 100 days post-transplant. However, some patients may recover their CMV-specific immunity earlier, while others may need longer protection.
In this study, researchers will use a dynamic monitoring technology (QuantiFERON-CMV) to detect the level of CMV-specific T-cells in patients. Participants will be randomly assigned to either the experimental group or the control group:
Experimental Group: Letermovir discontinuation will be guided by T-cell recovery. If the test shows that the patient's CMV-specific T-cells have recovered, Letermovir may be stopped earlier than the standard 100 days.
Control Group: Patients will receive the standard Letermovir prophylaxis for approximately 100 days, regardless of T-cell status.
The study aims to determine if this immune-guided strategy can effectively prevent CMV infection while potentially reducing the duration of medication and associated costs, without increasing the risk of CMV disease.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 4
Kontakter og plasseringer
Studiekontakt
- Navn: wei MD, PhD
- Telefonnummer: +86 027-85726003
- E-post: shiwei076@hust.edu.cn
Studiesteder
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100853
- Har ikke rekruttert ennå
- Chinese PLA General Hospital
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Ta kontakt med:
- Fei Li
- Telefonnummer: +86 18611406860
- E-post: 847982123@qq.com
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Hebei
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Shijiazhuang, Hebei, Kina, 050000
- Har ikke rekruttert ennå
- The Second Hospital of Hebei Medical University
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Ta kontakt med:
- Fuxu Wang
- Telefonnummer: +86 13931100360
- E-post: 827064030@qq.com
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Henan
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Zhengzhou, Henan, Kina, 450008
- Har ikke rekruttert ennå
- Henan Cancer Hospital
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Ta kontakt med:
- Jian Zhou
- Telefonnummer: +86 13623822347
- E-post: zhoujiandoctor@163.com
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Zhengzhou, Henan, Kina, 450052
- Har ikke rekruttert ennå
- The First Affiliated Hospital of Zhengzhou University
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Ta kontakt med:
- Weijie Cao
- Telefonnummer: +86 15093360671
- E-post: caoweijie2003@126.com
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Hubei
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Jingzhou, Hubei, Kina, 434020
- Har ikke rekruttert ennå
- Jingzhou Central Hospital
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Ta kontakt med:
- Yuanyan Tang
- Telefonnummer: +86 18107168243
- E-post: 343665915@qq.com
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Jingzhou, Hubei, Kina, 434000
- Har ikke rekruttert ennå
- Jingzhou First People's Hospital
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Ta kontakt med:
- Jie Tan
- Telefonnummer: +86 18163137226
- E-post: Tanjie@yangtzeu.edu.cn
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Wuhan, Hubei, Kina, 430071
- Har ikke rekruttert ennå
- Zhongnan Hospital of Wuhan University
-
Ta kontakt med:
- Fei Chen
- Telefonnummer: +86 13545297071
- E-post: chenfeiwhu@whu.edu.cn
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Wuhan, Hubei, Kina, 430030
- Har ikke rekruttert ennå
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
Ta kontakt med:
- Yang Cao
- Telefonnummer: +86 13986142606
- E-post: caoyangemma@163.com
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Wuhan, Hubei, Kina, 430022
- Rekruttering
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
Ta kontakt med:
- Wei Shi, M.D.
- Telefonnummer: +86 027-85726003
- E-post: shiwei076@hust.edu.cn
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Inner Mongolia
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Hohhot, Inner Mongolia, Kina, 010050
- Har ikke rekruttert ennå
- The Affiliated Hospital of Inner Mongolia Medical University
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Ta kontakt med:
- Da Gao
- Telefonnummer: +86 13947130473
- E-post: gaoda72@163.com
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Jiangxi
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Nanchang, Jiangxi, Kina, 330006
- Har ikke rekruttert ennå
- The First Affiliated Hospital of Nanchang University
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Ta kontakt med:
- Xianbao Huang
- Telefonnummer: +86 18679119505
- E-post: huangxianbao2017@163.com
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Zhejiang
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Wenzhou, Zhejiang, Kina, 325000
- Har ikke rekruttert ennå
- The First Affiliated Hospital of Wenzhou Medical University
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Ta kontakt med:
- Lan Sun Sun
- Telefonnummer: +86 13587685726
- E-post: sunlan91@126.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Recipients of allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- CMV serostatus of the recipient is positive (R+).
- Aged 18 years or older.
- Expected survival > 6 months.
- Provision of signed informed consent.
Exclusion Criteria:
1.Active CMV infection or CMV disease at the time of screening.
2.Known hypersensitivity to Letermovir or its excipients.
3.Severe hepatic or renal impairment.
4.Pregnant or breastfeeding women.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Experimental (T-cell Guided Group)
|
Patients receive Letermovir prophylaxis (480 mg/day orally or IV) according to the standard protocol until approximately 100 days post-transplantation, regardless of T-cell recovery status.
|
|
Aktiv komparator: Active Comparator (Standard Prophylaxis Group)
|
Patients receive Letermovir prophylaxis (480 mg/day orally or IV) according to the standard protocol until approximately 100 days post-transplantation, regardless of T-cell recovery status.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of Clinically Significant CMV Infection (CS-CMVi)
Tidsramme: Through 200 days post-transplantation
|
The percentage of participants who develop clinically significant CMV infection, defined as CMV DNAemia requiring preemptive antiviral therapy (PET) according to institutional guidelines (e.g., two consecutive positive results or a single viral load ≥ 500 copies/mL) or the occurrence of CMV disease (e.g., CMV pneumonia, enteritis, or retinitis).
|
Through 200 days post-transplantation
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Duration of Letermovir Prophylaxis
Tidsramme: Through 200 days post-transplantation
|
The total number of days each participant received Letermovir prophylaxis from the start of treatment (between Day 0 and Day 28 post-HSCT) until the end of the intervention (up to 200 days).
This measure will compare the median duration of medication between the experimental arm (T-cell guided) and the control arm (standard 200-day prophylaxis) to evaluate the reduction in drug exposure.
|
Through 200 days post-transplantation
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- [2025]num(0974)
Plan for individuelle deltakerdata (IPD)
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