Evaluation of CMV/EBV-CMI in Haploid HSCT

Recruiting

• Conditions: Cytomegalovirus Infections; Hematopoietic Stem Cell Transplantation; Epstein-Barr Virus Infections

• Registration Number: NCT06554197
• Lead Sponsor: The First Affiliated Hospital of Soochow University

Brief Summary

The purpose of this prospective, open-label, Single Arm, single-center study is to evaluate the cytomegalovirus and Epstein-Barr virus specific immune reestablishment for patients with hemopathy undergoingin prophylaxis for cytomegalovirus in haploid hematopoietic stem cell transplantation(haplo-HSCT) .

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-08-13
• Study First Submitted: 2024-08-13
• Study First Submitted QC: 2024-08-13
• Last Update Submitted: 2024-08-13
• Study First Posted: 2024-08-15
• Last Update Posted: 2024-08-15
• Primary Completion: 2025-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. All patients were diagnosed with hemopathy.
2. All patients should have the indication of Haploidentical hematopoietic stem cell transplant and receive the prophylaxis for cytomegalovirus.
3. All patients should sign an informed consent document indicating that they understand the purpose of and procedures required for the study and be willing to participate in the study.

Exclusion Criteria

Patients with any conditions not suitable for the trial (investigators' decision).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CMV-CMI	6 months after transplantation	CMV specific immune reconstitution from pre-HSCT to 180 days after HSCT
EBV-CMI	6 months after transplantation	EBV specific immune reconstitution from pre-HSCT to 180 days after HSCT

Secondary Outcome Measures

Name	Time	Method
Non-relapse mortality (NRM)	1 years after transplantation	Non-relapse mortality (NRM) is defined as the time from enrollment to death of any causes other than hematologic disease relapse.
Overall survival (OS)	1 years after transplantation	Overall survival (OS) is defined as the time from randomization to death resulting from any cause.
Cumulative incidence of CMV reactivation	1 years after transplantation	The cumulative incidences of CMV reactivation after transplantation.
Cumulative incidences of EBV reactivation	1 years after transplantation	The cumulative incidences of EBV reactivation after transplantation
GVHD-free and relapse-free survival (GRFS)	1 years after transplantation	GRFS is defined as the time from graft infusion to the onset of grades 3 to 4 aGVHD, moderate to severe cGVHD, or relapse/disease progression/death.
Cumulative incidences of aGVHD	100 days after transplantation	The diagnosis and grading of aGVHD are based on the modified Glucksberg grading standard.
Relapse-related mortality (RRM)	1 years after transplantation	Relapse-related mortality (RRM) is defined as the time from enrollment to death of relapse.

Trial Locations

Locations (1)

First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China