About this trial
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) .
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
Patients are diagnosed with hemopathy and should have the indication of Haploidentical hematopoietic stem cell transplant and receive the prophylaxis for cytomegalovirus.
Trial design
Cohort
Prospective
Treatments tested in this trial
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.
Treatment groups
Trial outcomes
Primary outcomes
CMV-CMI
CMV specific immune reconstitution from pre-HSCT to 180 days after HSCT
EBV-CMI
EBV specific immune reconstitution from pre-HSCT to 180 days after HSCT
Secondary outcomes
Cumulative incidence of CMV reactivation
The cumulative incidences of CMV reactivation after transplantation.
Cumulative incidences of EBV reactivation
The cumulative incidences of EBV reactivation after transplantation
Overall survival (OS)
Overall survival (OS) is defined as the time from randomization to death resulting from any cause.
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.
Sponsors and contacts
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