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

NCT05656599 | Unknown

• 1 other identifier: 2021PHB423-001
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

CMV Infection; Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• Treatment-ralated mortality

  Through study completion, an average of 1 year

• Overall survival

  Through study completion, an average of 1 year

• Incidence of other viral infection and viral-associated disease

  6 months after HSCT

Study Arms (2)

Letermovir Group

HSCT recipients who received letermovir prophylaxis

Drug: Letermovir

Preemptive therapy Group

HSCT recipients who received PCR-guided preemptive therapy

Interventions

Letermovir DRUG

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

Letermovir Group

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients who received allogeneic HSCT.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (2)

Department of Hematology, Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

People's Hospital of Peking University

Beijing, China

Location

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

letermovir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of the department

Study Record Dates

• First Submitted: November 25, 2022
• First Posted: December 19, 2022
• Study Start: January 3, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: January 3, 2024

Record last verified: 2023-12

Locations

CN (2)