Immune Reconstitution to CMV After HSCT: Impact of Clinical Factors and Therapy Strategies
NCT ID: NCT05656599
Last Updated: 2024-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
120 participants
OBSERVATIONAL
2023-01-03
2025-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Letermovir Group
HSCT recipients who received letermovir prophylaxis
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
No interventions assigned to this group
Interventions
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Letermovir
Patients received letermovir as prophylaxis or received preemptive therapy for CMV depends on clinical needs and patients' wishes
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
14 Years
75 Years
ALL
Yes
Sponsors
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Peking University People's Hospital
OTHER
Responsible Party
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Xiao-Jun Huang
Chairman of the department
Locations
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Department of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, China
People's Hospital of Peking University
Beijing, , China
Countries
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Other Identifiers
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2021PHB423-001
Identifier Type: -
Identifier Source: org_study_id
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