An observational study in Hematopoietic Stem Cell Transplantation, Cytomegalovirus Infections and Epstein-Barr Virus Infections, sponsored by The First Affiliated Hospital of Soochow University. Status unknown at 1 site in China. Open to participants aged 16 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-08-15.
Sponsored by The First Affiliated Hospital of Soochow University · Observational
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) .
362 studies on the registry are indexed under Cytomegalovirus Infections; 59 are open to participants now.
This study's planned enrollment of 60 is below the median of 150 across 100 observational studies indexed under Cytomegalovirus Infections.
Browse Cytomegalovirus Infections studies →The First Affiliated Hospital of Soochow University is the lead sponsor of 258 studies on the registry; 149 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients are diagnosed with hemopathy and should have the indication of Haploidentical hematopoietic stem cell transplant and receive the prophylaxis for cytomegalovirus.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with any conditions not suitable for the trial (investigators' decision).
The CMV/EBV-CMI is tested before conditioning regimen and 30 days, 45 days, 60 days, 90 days, 120 days, 180 days after transplantation.
CMV-CMI
CMV specific immune reconstitution from pre-HSCT to 180 days after HSCT
Time frame: 6 months after transplantation
EBV-CMI
EBV specific immune reconstitution from pre-HSCT to 180 days after HSCT
Time frame: 6 months after transplantation
Cumulative incidence of CMV reactivation
The cumulative incidences of CMV reactivation after transplantation.
Time frame: 1 years after transplantation
Cumulative incidences of EBV reactivation
The cumulative incidences of EBV reactivation after transplantation
Time frame: 1 years after transplantation
Overall survival (OS)
Overall survival (OS) is defined as the time from randomization to death resulting from any cause.
Time frame: 1 years after transplantation
Non-relapse mortality (NRM)
Non-relapse mortality (NRM) is defined as the time from enrollment to death of any causes other than hematologic disease relapse.
Time frame: 1 years after transplantation
Relapse-related mortality (RRM)
Relapse-related mortality (RRM) is defined as the time from enrollment to death of relapse.
Time frame: 1 years after transplantation
GVHD-free and relapse-free survival (GRFS)
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.
Time frame: 1 years after transplantation
Cumulative incidences of aGVHD
The diagnosis and grading of aGVHD are based on the modified Glucksberg grading standard.
Time frame: 100 days after transplantation
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Soochow University →