Effect of Letermovir Prophylaxis on CMV-specific Immune Reconstitution Post UCBT

NCT ID: NCT06441669

Last Updated: 2024-06-04

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2026-05-20

Brief Summary

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To explore the effect of letermovir prophylaxis on cytomegalovirus-specific immune reconstitution post unrelated cord blood transplantation

Detailed Description

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To explore the effect of letermovir prophylaxis on cytomegalovirus-specific and other lymphocyte subsets immune reconstitution post unrelated cord blood transplantation, and to analyze the potential mechanism and risk factors of late CMV reactivation after letermovir discontinuation.

Conditions

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Cytomegalovirus Infection Reactivation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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letermovir group

Patients will be given Letermovir with a recommended dose of 480 mg per day (or 240 mg per day in patients taking cyclosporine or according to clinical instructions) from +1 day to +100 days after UCBT.

Letermovir

Intervention Type DRUG

Patients will be given Letermovir with a recommended dose from +1 day to +100 days after UCBT.

Interventions

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Letermovir

Patients will be given Letermovir with a recommended dose from +1 day to +100 days after UCBT.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients are receiving a first unrelated cord blood transplantation (UCBT).
* Patients start letemovir prophylaxis within 0-28 days post UCBT.

Exclusion Criteria

* Patients having active CMV DNAemia at the time of letermovir initiation.
* Patients recruited in a clinical study on an anti-CMV trial.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anhui Provincial Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiaoyu Zhu, ph.D

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of University of Science and Technology of China (Anhui Provicial Hospital)

Locations

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Anhui Provincial Hospital

Hefei, Anhui, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaoyu Zhu, ph.D

Role: CONTACT

15255456091

Bingbing Yan

Role: CONTACT

15993691727

Facility Contacts

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Xiaoyu Zhu, ph.D

Role: primary

15255456091

Bingbing Yan

Role: backup

15993691727

Other Identifiers

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CBCMV001

Identifier Type: -

Identifier Source: org_study_id

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