Letermovir Prophylaxis Duration Guided by CMV-Specific T-cell Monitoring After Allo-HSCT.

Официальное название

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.

Обзор

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.

Вмешательства

• Препарат CMV-Specific T-cell Guided Letermovir Discontinuation
  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.
• Препарат Standard Letermovir Prophylaxis
  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.

Первичные конечные точки

• Incidence of Clinically Significant CMV Infection (CS-CMVi) [Срок оценки: Through 200 days post-transplantation]

Вторичные конечные точки (1)

• Duration of Letermovir Prophylaxis [Срок оценки: Through 200 days post-transplantation]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 12 центров

• Chinese PLA General Hospital — Пекин
• The Second Hospital of Hebei Medical University — Shijiazhuang
• Henan Cancer Hospital — Чжэнчжоу
• The First Affiliated Hospital of Zhengzhou University — Чжэнчжоу
• Jingzhou First People's Hospital — Jingzhou
• Jingzhou Central Hospital — Jingzhou
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань
• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань
• … и ещё 4 центра

Идентификаторы

NCT: NCT07569653 · [2025]num(0974)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗