Using the Composite Immune Risk Score to Assess and Modulate the Patient's Post-transplant Immune Reconstitution.

August 11, 2024 updated by: Institute of Hematology & Blood Diseases Hospital, China

Using the Composite Immune Risk Score to Assess and Modulate the Patient's Immune Reconstitution After Allogeneic Hematopoietic Stem Cell Transplantation, a Prospective, Multicenter, Randomized Controlled Study.

To assess the effectiveness of interventions including health monitoring and regular return follow-up reminders for patients with a high Composite Immune Risk Score.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to prospectively evaluate the effectiveness of the Composite Immune Risk Score in real-world clinical setting.

Study Type

Interventional

Enrollment (Estimated)

456

Phase

  • Not Applicable

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 Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300020
        • Recruiting
        • Institute of Hematology & Blood Diseases Hospital
        • 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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1) Patients must be ≥ 16 years of age;
  • 2) Patients receiving haploidentical allo-HSCT;
  • 3) Patients have to sign an informed consent form before the start of the research procedure.

Exclusion Criteria:

  • 1) Tandem transplantation or multiple transplantations;
  • 2) Mental or other medical conditions that make the patients unable to comply with the research treatment and monitoring requirements;
  • 3) Patients who are ineligible for the study due to other factors, or will bear great risk if participating in the study.

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Remind patients to test their immune status among 120-180 days post-transplantation. Physicians assessed the risk level of patients in the intervention group based on their immune status on days 91-180 using the CIRS.
Behavioral: Health monitoring and regular return follow-up reminders
Health monitoring & reminders for blood tests and follow-up visits until 1 year post-transplant
No Intervention: Control group
Only remind patients to test their immune status among 120-180 days post-transplantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 1.5 years after transplantation
Overall survival during 1.5 years after transplantation
1.5 years after transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-relapse mortality rate
Time Frame: 1.5 years after transplantation
Non-relapse mortality rate during 1.5 years after transplantation
1.5 years after transplantation
Incidence of infections
Time Frame: 1.5 years after transplantation
Infections during 1.5 years after transplantation
1.5 years after transplantation
Immune cell count
Time Frame: 1.5 years after transplantation
Data on immune cell count will be collected during 1.5 years after transplantation
1.5 years after transplantation

Collaborators and Investigators

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

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

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 (Actual)

February 29, 2024

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

January 5, 2024

First Submitted That Met QC Criteria

January 5, 2024

First Posted (Actual)

January 17, 2024

Study Record Updates

Last Update Posted (Actual)

August 13, 2024

Last Update Submitted That Met QC Criteria

August 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • IIT2023022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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