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

Not Applicable

Recruiting

• Conditions: Transplant-Related Disorder
• Interventions: Behavioral: Health monitoring and regular return follow-up reminders

• Registration Number: NCT06208137
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2024-01-05
• Study First Submitted QC: 2024-01-05
• Study First Posted: 2024-01-17
• Study Start: 2024-02-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-08-11
• Last Update Posted: 2024-08-13
• Primary Completion: 2027-10-01
• Study Completion: 2028-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 456

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Health monitoring and regular return follow-up reminders	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.

Primary Outcome Measures

Name	Time	Method
Survival	1.5 years after transplantation	Overall survival during 1.5 years after transplantation

Secondary Outcome Measures

Name	Time	Method
Non-relapse mortality rate	1.5 years after transplantation	Non-relapse mortality rate during 1.5 years after transplantation
Incidence of infections	1.5 years after transplantation	Infections during 1.5 years after transplantation
Immune cell count	1.5 years after transplantation	Data on immune cell count will be collected during 1.5 years after transplantation

Trial Locations

Locations (1)

Institute of Hematology & Blood Diseases Hospital; 🇨🇳 Tianjin, Tianjin, China