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

Institute of Hematology & Blood Diseases Hospital, China

Status: Not yet enrolling

Conditions: Transplant-Related Disorder

Treatments: Behavioral: Health monitoring and regular return follow-up reminders

Study type: Interventional

Funder types: Other

Identifiers

NCT06208137

SKIRT-001

Details and patient eligibility

About

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

Full description

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

Enrollment: 456 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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456 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: Health monitoring and regular return follow-up reminders

Control group

No Intervention group

Description:

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