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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 4
Kontakter och platser
Studiekontakt
- Namn: wei MD, PhD
- Telefonnummer: +86 027-85726003
- E-post: shiwei076@hust.edu.cn
Studieorter
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100853
- Har inte rekryterat ännu
- Chinese PLA General Hospital
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Kontakt:
- Fei Li
- Telefonnummer: +86 18611406860
- E-post: 847982123@qq.com
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Hebei
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Shijiazhuang, Hebei, Kina, 050000
- Har inte rekryterat ännu
- The Second Hospital of Hebei Medical University
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Kontakt:
- Fuxu Wang
- Telefonnummer: +86 13931100360
- E-post: 827064030@qq.com
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Henan
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Zhengzhou, Henan, Kina, 450008
- Har inte rekryterat ännu
- Henan Cancer Hospital
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Kontakt:
- Jian Zhou
- Telefonnummer: +86 13623822347
- E-post: zhoujiandoctor@163.com
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Zhengzhou, Henan, Kina, 450052
- Har inte rekryterat ännu
- The First Affiliated Hospital of Zhengzhou University
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Kontakt:
- Weijie Cao
- Telefonnummer: +86 15093360671
- E-post: caoweijie2003@126.com
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Hubei
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Jingzhou, Hubei, Kina, 434020
- Har inte rekryterat ännu
- Jingzhou Central Hospital
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Kontakt:
- Yuanyan Tang
- Telefonnummer: +86 18107168243
- E-post: 343665915@qq.com
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Jingzhou, Hubei, Kina, 434000
- Har inte rekryterat ännu
- Jingzhou First People's Hospital
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Kontakt:
- Jie Tan
- Telefonnummer: +86 18163137226
- E-post: Tanjie@yangtzeu.edu.cn
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Wuhan, Hubei, Kina, 430071
- Har inte rekryterat ännu
- Zhongnan Hospital of Wuhan University
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Kontakt:
- Fei Chen
- Telefonnummer: +86 13545297071
- E-post: chenfeiwhu@whu.edu.cn
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Wuhan, Hubei, Kina, 430030
- Har inte rekryterat ännu
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Kontakt:
- Yang Cao
- Telefonnummer: +86 13986142606
- E-post: caoyangemma@163.com
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Wuhan, Hubei, Kina, 430022
- Rekrytering
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Kontakt:
- 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 inte rekryterat ännu
- The Affiliated Hospital of Inner Mongolia Medical University
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Kontakt:
- Da Gao
- Telefonnummer: +86 13947130473
- E-post: gaoda72@163.com
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Jiangxi
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Nanchang, Jiangxi, Kina, 330006
- Har inte rekryterat ännu
- The First Affiliated Hospital of Nanchang University
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Kontakt:
- Xianbao Huang
- Telefonnummer: +86 18679119505
- E-post: huangxianbao2017@163.com
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Zhejiang
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Wenzhou, Zhejiang, Kina, 325000
- Har inte rekryterat ännu
- The First Affiliated Hospital of Wenzhou Medical University
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Kontakt:
- Lan Sun Sun
- Telefonnummer: +86 13587685726
- E-post: sunlan91@126.com
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of Clinically Significant CMV Infection (CS-CMVi)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Duration of Letermovir Prophylaxis
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
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Andra studie-ID-nummer
- [2025]num(0974)
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