Evaluation of CMV/EBV-CMI in Haploid HSCT
Evaluation of Cytomegalovirus and Epstein-Barr Virus Specific Immune Reformulation in Prophylaxis for Cytomegalovirus in Haploid Hematopoietic Stem Cell Transplantation
1 other identifier
observational
60
1 country
1
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) .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2024
CompletedStudy Start
First participant enrolled
August 13, 2024
CompletedFirst Posted
Study publicly available on registry
August 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
ExpectedAugust 15, 2024
August 1, 2024
12 months
August 13, 2024
August 13, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
CMV-CMI
CMV specific immune reconstitution from pre-HSCT to 180 days after HSCT
6 months after transplantation
EBV-CMI
EBV specific immune reconstitution from pre-HSCT to 180 days after HSCT
6 months after transplantation
Secondary Outcomes (7)
Cumulative incidence of CMV reactivation
1 years after transplantation
Cumulative incidences of EBV reactivation
1 years after transplantation
Overall survival (OS)
1 years after transplantation
Non-relapse mortality (NRM)
1 years after transplantation
Relapse-related mortality (RRM)
1 years after transplantation
- +2 more secondary outcomes
Interventions
The CMV/EBV-CMI is tested before conditioning regimen and 30 days, 45 days, 60 days, 90 days, 120 days, 180 days after transplantation.
Eligibility Criteria
Patients are diagnosed with hemopathy and should have the indication of Haploidentical hematopoietic stem cell transplant and receive the prophylaxis for cytomegalovirus.
You may qualify if:
- All patients were diagnosed with hemopathy.
- All patients should have the indication of Haploidentical hematopoietic stem cell transplant and receive the prophylaxis for cytomegalovirus.
- 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.
You may not qualify if:
- Patients with any conditions not suitable for the trial (investigators' decision).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2024
First Posted
August 15, 2024
Study Start
August 13, 2024
Primary Completion
July 31, 2025
Study Completion (Estimated)
July 31, 2026
Last Updated
August 15, 2024
Record last verified: 2024-08