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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.

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Chinese PLA General Hospital
NOT_YET_RECRUITING
Beijing
The Affiliated Hospital of Inner Mongolia Medical University
NOT_YET_RECRUITING
Hohhot
Jingzhou Central Hospital
NOT_YET_RECRUITING
Jingzhou
Jingzhou First People's Hospital
NOT_YET_RECRUITING
Jingzhou
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
The Second Hospital of Hebei Medical University
NOT_YET_RECRUITING
Shijiazhuang
The First Affiliated Hospital of Wenzhou Medical University
NOT_YET_RECRUITING
Wenzhou
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Zhongnan Hospital of Wuhan University
NOT_YET_RECRUITING
Wuhan
Henan Cancer Hospital
NOT_YET_RECRUITING
Zhengzhou
The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
wei MD, PhD
shiwei076@hust.edu.cn
+86 027-85726003
Time Frame
Start Date: 2025-10-30
Estimated Completion Date: 2027-12
Participants
Target number of participants: 120
Treatments
Experimental: Experimental (T-cell Guided Group)
Active_comparator: Active Comparator (Standard Prophylaxis Group)
Sponsors
Leads: WeiShi

This content was sourced from clinicaltrials.gov

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