Immune Reconstitution to CMV After HSCT: Impact of Clinical Factors and Therapy Strategies
- Conditions
- Hematopoietic Stem Cell TransplantationCMV Infection
- Interventions
- Registration Number
- NCT05656599
- Lead Sponsor
- Peking University People's Hospital
- Brief Summary
Cytomegalovirus (CMV) remains a significant cause of morbidity and mortality after hematopoietic stem cell transplantation (HSCT). The course and outcome of CMV infection are different clinically, and the mechanism of CMV infection after transplantation has not been clarified. Reconstitution of cellular immunity after HSCT is a critical determinant of the control of CMV infection.
Investigators will dynamically monitor the CMV-specific cellular immune reconstitution after HSCT，and analyze the clinical factors and therapy strategies affecting recovery of CMV-specific immunity during 1 year after HSCT.
- Detailed Description
Cytomegalovirus (CMV) remains a significant cause of morbidity and mortality after hematopoietic stem cell transplantation (HSCT). The course and outcome of CMV infection are different clinically, and the mechanism of CMV infection after transplantation has not been clarified. Reconstitution of cellular immunity after HSCT is a critical determinant of the control of CMV infection.
Investigators will collect peripheral blood at 1 month, 2 month, 3 month, and 6 month after HSCT from the participated patients, and dynamically monitor the CMV-specific T and NK cellular immune reconstitution.
Investigators will also analyze the clinical factors and therapy strategies affecting recovery of CMV-specific immunity during 1 year after HSCT.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 120
- Be receiving a first allogeneic HSCT.
- Is male or female, from 14 years to any years of age inclusive.
- The participant (or legally acceptable representative) agree for cellular immune investigation and has provided documented informed consent/assent for the study.
- Received a previous allogeneic HSCT (Note: Receipt of a previous autologous HSCT is acceptable).
- Has a history of CMV end-organ disease within 6 months prior to allocation.
- Has severe organ (hepatic , renal, cardical) insufficiency within 5 days prior to allocation.
- Any rapidly-progressing disease or immediately life-threatening illness.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Letermovir Group Letermovir HSCT recipients who received letermovir prophylaxis
- Primary Outcome Measures
Name Time Method Numbers of immune cells in peripheral blood 6 months after HSCT PBMCs from HSCT recipients were collected at 1 month, 2 month, 3 month, and 6 month after HSCT, and tested for NK cells, T cells, CMV-specific T cells and their subsets.
Incidence of clinically significant CMV infection (CSI) 6 months after HSCT Clinically significant CMV infection (CSI) is defined as the administration of antiviral therapy as preemptive therapy for CMV DNAemia or treatment for CMV disease.
Incidence of refractory CMV infection and CMV disease 6 months after HSCT Refractory CMV infection is defined as a persistent viral load (CMV viral load at the same level or higher than the peak viral load within 1 week but \<1 log10 increase in CMV DNA titers done in the same laboratory and with the same assay) after at least 2 weeks of appropriately dosed antiviral therapy.
- Secondary Outcome Measures
Name Time Method Treatment-ralated mortality Through study completion, an average of 1 year Treatment-ralated mortality
Overall survival Through study completion, an average of 1 year Overall survival
Incidence of other viral infection and viral-associated disease 6 months after HSCT Other viral infection and viral-associated diseases including EBV, ADV, HHV-6, BKV and HSV
Trial Locations
- Locations (2)
Department of Hematology, Peking University People's Hospital
🇨🇳Beijing, Beijing, China
People's Hospital of Peking University
🇨🇳Beijing, China