Allogeneic Hematogenic Stem Cell Transplantation
Conditions
Interventions
NA:NA
Sponsors
Shanghai Chidren's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: ?Pediatric patients (<18 years old) at the time of receiving their first primary allo-HSCT within the index period of January 1st, 2016-December 31th, 2022; ? Documented CMV serology of both recipient and donor examined prior to the day of transplantation; ? Absence of positive CMV viremia confirmed by CMV DNA qPCR or pp65 antigen examination within 14 days prior to or on the day of transplantation; ? Absence of CMV disease diagnosed within 14 days prior to the day of transplantation; ? Recipient has study data available, from participating site, and accessible to the study personnel for the 24 weeks post-transplant, or, data availability up until loss to follow-up or death during this 24 weeks post-transplant; ? Patient provides informed consent if applicable.
Exclusion criteria
Exclusion criteria: ? Patients received a previous HSCT; ? Patients participated in an interventional therapeutic study 28 days prior to transplantation or within 24 weeks post-transplantation; ? Recipient had any exposure to prophylaxis therapy for CMV infection within 24 weeks post-transplantation; ? Recipient had any exposure to Letermovir.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the cumulative incidence of clinically significant CMV infection through Week 24 after primary allo-HSCT in all pediatric patients; | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the cumulative incidence of clinically significant CMV infections through 24 weeks after transplantation in recipients with different CMV serostatus (D-/R+. D+/R+. D+/R-, and D-/R-), in recipients of different transplants form (HLA-matched related, Haploidentical, or HLA-matched unrelated) and different sources of stem cell, respectively; And to determine the incidence of neutropenia through 24 weeks after transplantation;To compare the cumulative incidence of clinically significant CMV infections in recipients with different CMV serostatus (D-/R+, D+/R+. D+/R-, and D-/R-).;To determine risk factors of clinically significant CMV infection.;To determine the impact of clinically significant CMV infections through 24 weeks after transplantation: Allo-HSCT related clinical outcomes.; | — |
Countries
China
Contacts
Public ContactJing Chen
Shanghai Chidren's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed