Evaluation of CMV/EBV-CMI in Haploid HSCT

August 13, 2024 updated by: The First Affiliated Hospital of Soochow University

Evaluation of Cytomegalovirus and Epstein-Barr Virus Specific Immune Reformulation in Prophylaxis for Cytomegalovirus in Haploid Hematopoietic Stem Cell Transplantation

The purpose of this prospective, open-label, Single Arm, single-center study is to evaluate the cytomegalovirus and Epstein-Barr virus specific immune reestablishment for patients with hemopathy undergoingin prophylaxis for cytomegalovirus in haploid hematopoietic stem cell transplantation(haplo-HSCT) .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • Recruiting
        • First Affiliated Hospital of Soochow University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients are diagnosed with hemopathy and should have the indication of Haploidentical hematopoietic stem cell transplant and receive the prophylaxis for cytomegalovirus.

Description

Inclusion Criteria:

  1. All patients were diagnosed with hemopathy.
  2. All patients should have the indication of Haploidentical hematopoietic stem cell transplant and receive the prophylaxis for cytomegalovirus.
  3. All patients should sign an informed consent document indicating that they understand the purpose of and procedures required for the study and be willing to participate in the study.

Exclusion Criteria:

Patients with any conditions not suitable for the trial (investigators' decision).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CMV-CMI
Time Frame: 6 months after transplantation
CMV specific immune reconstitution from pre-HSCT to 180 days after HSCT
6 months after transplantation
EBV-CMI
Time Frame: 6 months after transplantation
EBV specific immune reconstitution from pre-HSCT to 180 days after HSCT
6 months after transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative incidences of aGVHD
Time Frame: 100 days after transplantation
The diagnosis and grading of aGVHD are based on the modified Glucksberg grading standard.
100 days after transplantation
Cumulative incidences of EBV reactivation
Time Frame: 1 years after transplantation
The cumulative incidences of EBV reactivation after transplantation
1 years after transplantation
Cumulative incidence of CMV reactivation
Time Frame: 1 years after transplantation
The cumulative incidences of CMV reactivation after transplantation.
1 years after transplantation
Overall survival (OS)
Time Frame: 1 years after transplantation
Overall survival (OS) is defined as the time from randomization to death resulting from any cause.
1 years after transplantation
GVHD-free and relapse-free survival (GRFS)
Time Frame: 1 years after transplantation
GRFS is defined as the time from graft infusion to the onset of grades 3 to 4 aGVHD, moderate to severe cGVHD, or relapse/disease progression/death.
1 years after transplantation
Non-relapse mortality (NRM)
Time Frame: 1 years after transplantation
Non-relapse mortality (NRM) is defined as the time from enrollment to death of any causes other than hematologic disease relapse.
1 years after transplantation
Relapse-related mortality (RRM)
Time Frame: 1 years after transplantation
Relapse-related mortality (RRM) is defined as the time from enrollment to death of relapse.
1 years after transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 13, 2024

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

August 13, 2024

First Submitted That Met QC Criteria

August 13, 2024

First Posted (Actual)

August 15, 2024

Study Record Updates

Last Update Posted (Actual)

August 15, 2024

Last Update Submitted That Met QC Criteria

August 13, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMV/EBV-CMI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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