Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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) .
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CMV/EBV-CMI | Diagnostic Test | The CMV/EBV-CMI is tested before conditioning regimen and 30 days, 45 days, 60 days, 90 days, 120 days, 180 days after transplantation. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of CMV reactivation | The cumulative incidences of CMV reactivation after transplantation. | 1 years after transplantation |
| Cumulative incidences of EBV reactivation | The cumulative incidences of EBV reactivation after transplantation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patients with any conditions not suitable for the trial (investigators' decision).
Not provided
Not provided
Patients are diagnosed with hemopathy and should have the indication of Haploidentical hematopoietic stem cell transplant and receive the prophylaxis for cytomegalovirus.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng Chen, PhD | Contact | 13584861215 | 13584861215@163.com | |
| Depei Wu, PhD | Contact | 67781856 | drwudepei@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215006 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003586 | Cytomegalovirus Infections |
| D020031 | Epstein-Barr Virus Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
| 1 years after transplantation |
| Overall survival (OS) | Overall survival (OS) is defined as the time from randomization to death resulting from any cause. | 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. | 1 years after transplantation |
| Relapse-related mortality (RRM) | Relapse-related mortality (RRM) is defined as the time from enrollment to death of relapse. | 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. | 1 years after transplantation |
| Cumulative incidences of aGVHD | The diagnosis and grading of aGVHD are based on the modified Glucksberg grading standard. | 100 days after transplantation |
| D014412 |
| Tumor Virus Infections |