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

NCT ID: NCT06208137

Last Updated: 2024-08-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 456 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-29
• Study Completion Date: 2028-04-01

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.

Conditions

Transplant-Related Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Health monitoring and regular return follow-up reminders

Intervention Type: BEHAVIORAL

Health monitoring \& reminders for blood tests and follow-up visits until 1 year post-transplant

Control group

Only remind patients to test their immune status among 120-180 days post-transplantation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Health monitoring and regular return follow-up reminders

Health monitoring \& reminders for blood tests and follow-up visits until 1 year post-transplant

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yahui Feng, MS

Role: CONTACT

fengyahui@ihcams.ac.cn

022-23909051

Facility Contacts

Yahui Feng, MS

Role: primary

fengyahui@ihcams.ac.cn

022-23909051

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

IIT2023022

Identifier Type: -

Identifier Source: org_study_id