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

I

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;
    1. Patients receiving haploidentical allo-HSCT;
    1. Patients have to sign an informed consent form before the start of the research procedure.

Exclusion criteria

    1. Tandem transplantation or multiple transplantations;
    1. Mental or other medical conditions that make the patients unable to comply with the research treatment and monitoring requirements;
    1. 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)

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.

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Yahui Feng, MS

Data sourced from clinicaltrials.gov

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