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

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: Transplant-Related Disorder
• Intervention / Treatment: Behavioral: Health monitoring and regular return follow-up reminders

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

• Study Contact: Name: Yahui Feng, MS; Phone Number: 022-23909051; Email: fengyahui@ihcams.ac.cn

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300020
      • Recruiting
      • Institute of Hematology & Blood Diseases Hospital
      • Contact: Yahui Feng, MS; Phone Number: 022-23909051; Email: fengyahui@ihcams.ac.cn

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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

Collaborators and Investigators

• Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Study record dates

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