Immune Reconstitution to CMV After HSCT: Impact of Clinical Factors and Therapy Strategies

Hematopoietic Stem Cell Transplantation Clinical Trial

Official title:

Immune Reconstitution to Cytomegalovirus After Allogeneic Hematopoietic Stem Cell Transplantation: Impact of Clinical Factors and Therapy Strategies

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05656599
• Other study ID #: 2021PHB423-001
• Status: Enrolling by invitation
• Start date: January 3, 2023
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• CMV Infection
• Cytomegalovirus Infections
• Hematopoietic Stem Cell Transplantation

Intervention

Drug:
• Letermovir
Patients received letermovir as prophylaxis or received preemptive therapy for CMV depends on clinical needs and patients' wishes

Locations

Country	Name	City	State
China	Department of Hematology, Peking University People's Hospital	Beijing	Beijing
China	People's Hospital of Peking University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of clinically significant CMV infection (CSI)	Clinically significant CMV infection (CSI) is defined as the administration of antiviral therapy as preemptive therapy for CMV DNAemia or treatment for CMV disease.	6 months after HSCT
Primary	Incidence of refractory CMV infection and CMV disease	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.	6 months after HSCT
Primary	Numbers of immune cells in peripheral blood	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.	6 months after HSCT
Secondary	Treatment-ralated mortality	Treatment-ralated mortality	Through study completion, an average of 1 year
Secondary	Overall survival	Overall survival	Through study completion, an average of 1 year
Secondary	Incidence of other viral infection and viral-associated disease	Other viral infection and viral-associated diseases including EBV, ADV, HHV-6, BKV and HSV	6 months after HSCT