Clinical trial NCT05656599: Immune Reconstitution to CMV After HSCT: Impact of Clinical Factors and Therapy Strategies
Official title: Immune Reconstitution to Cytomegalovirus After Allogeneic Hematopoietic Stem Cell Transplantation: Impact of Clinical Factors and Therapy Strategies
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: CMV Infection
Hematopoietic Stem Cell Transplantation
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 120
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients who received allogeneic HSCT.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of clinically significant CMV infection (CSI)
timeFrame: 6 months after HSCT
measure: Incidence of refractory CMV infection and CMV disease
timeFrame: 6 months after HSCT
measure: Numbers of immune cells in peripheral blood
timeFrame: 6 months after HSCT
Secondary outcomes:
measure: Treatment-ralated mortality
timeFrame: Through study completion, an average of 1 year
measure: Overall survival
timeFrame: Through study completion, an average of 1 year
measure: Incidence of other viral infection and viral-associated disease
timeFrame: 6 months after HSCT
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Hematology, Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: People's Hospital of Peking University
Study officials:
References: