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

• Sponsor: Peking University People's Hospital (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05656599
• Collaborator: (none)
• Enrollment: 120
• Locations: 2
• Anticipated Duration (Months): 35
• Patients Per Site: 60
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
CMV Infection; Hematopoietic Stem Cell Transplantation	Drug: Letermovir

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 120 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Immune Reconstitution to Cytomegalovirus After Allogeneic Hematopoietic Stem Cell Transplantation: Impact of Clinical Factors and Therapy Strategies
• Anticipated Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Letermovir Group HSCT recipients who received letermovir prophylaxis	Drug: Letermovir; Patients received letermovir as prophylaxis or received preemptive therapy for CMV depends on clinical needs and patients' wishes
Preemptive therapy Group HSCT recipients who received PCR-guided preemptive therapy

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

Secondary Outcome Measures

1. Treatment-ralated mortality [Through study completion, an average of 1 year]

   Treatment-ralated mortality

2. Overall survival [Through study completion, an average of 1 year]

   Overall survival

3. CMV treatment related cost [Through study completion, an average of 1 year]

   Medical expenses for direct treatment of CMV infection

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Be receiving a first allogeneic HSCT.

• Is male or female, from 18 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Hematology, Peking University People's Hospital	Beijing	Beijing	China	100044
2	People's Hospital of Peking University	Beijing		China

Sponsors and Collaborators

• Peking University People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiao-Jun Huang, Chairman of the department, Peking University People's Hospital
• ClinicalTrials.gov Identifier: NCT05656599
• Other Study ID Numbers: 2021PHB423-001
• First Posted: Dec 19, 2022
• Last Update Posted: Jan 6, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Cytomegalovirus Infections; Letermovir

Study Results

No Results Posted as of Jan 6, 2023