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

Peking University

Status: Invitation-only

Conditions: Hematopoietic Stem Cell Transplantation; CMV Infection

Treatments: Drug: Letermovir

Study type: Observational

Funder types: Other

Identifiers

NCT05656599

2021PHB423-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 14 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

120 participants in 2 patient groups

Letermovir Group

Description:

HSCT recipients who received letermovir prophylaxis

Treatment:

Drug: Letermovir

Preemptive therapy Group

Description:

HSCT recipients who received PCR-guided preemptive therapy