First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Location status: Recruiting
Recruiting
NCT Number: NCT06554197
Evaluation of CMV/EBV-CMI in Haploid HSCT
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) .
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
16 year–60 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
Patients with any conditions not suitable for the trial (investigators' decision).
Treatment and study plan
CMV/EBV-CMI
Diagnostic TestThe CMV/EBV-CMI is tested before conditioning regimen and 30 days, 45 days, 60 days, 90 days, 120 days, 180 days after transplantation.
Primary outcomes
-
CMV-CMI
Time frame: 6 months after transplantation
CMV specific immune reconstitution from pre-HSCT to 180 days after HSCT
-
EBV-CMI
Time frame: 6 months after transplantation
EBV specific immune reconstitution from pre-HSCT to 180 days after HSCT
Secondary outcomes
-
Cumulative incidence of CMV reactivation
Time frame: 1 years after transplantation
The cumulative incidences of CMV reactivation after transplantation.
-
Cumulative incidences of EBV reactivation
Time frame: 1 years after transplantation
The cumulative incidences of EBV reactivation after transplantation
-
Overall survival (OS)
Time frame: 1 years after transplantation
Overall survival (OS) is defined as the time from randomization to death resulting from any cause.
-
Non-relapse mortality (NRM)
Time frame: 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.
-
Relapse-related mortality (RRM)
Time frame: 1 years after transplantation
Relapse-related mortality (RRM) is defined as the time from enrollment to death of relapse.
-
GVHD-free and relapse-free survival (GRFS)
Time frame: 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
Time frame: 100 days after transplantation
The diagnosis and grading of aGVHD are based on the modified Glucksberg grading standard.
Study contacts
Contact information is provided by the study sponsor or research team.
Depei Wu, PhD
CONTACT
Feng Chen, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
The First Affiliated Hospital of Soochow University
Other
Registry information
Official study title
Evaluation of Cytomegalovirus and Epstein-Barr Virus Specific Immune Reformulation in Prophylaxis for Cytomegalovirus in Haploid Hematopoietic Stem Cell Transplantation
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2026
- First posted
- Aug 15, 2024
- Registry last updated
- Aug 15, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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