Cytomegalovirus Infections, Epstein-Barr Virus Infections, Hematopoietic Stem Cell Transplantation
Conditions
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) .
Interventions
DIAGNOSTIC_TESTCMV/EBV-CMI
The CMV/EBV-CMI is tested before conditioning regimen and 30 days, 45 days, 60 days, 90 days, 120 days, 180 days after transplantation.
Sponsors
The First Affiliated Hospital of Soochow University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 1 years after transplantation | Overall survival (OS) is defined as the time from randomization to death resulting from any cause. |
| 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. |
| Cumulative incidence of CMV reactivation | 1 years after transplantation | The cumulative incidences of CMV 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. |
| Cumulative incidences of EBV reactivation | 1 years after transplantation | The cumulative incidences of EBV reactivation after transplantation |
Countries
China
Contacts
Primary ContactFeng Chen, PhD
Backup ContactDepei Wu, PhD
Outcome results
None listed