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

NCT06208137 | Recruiting

• 1 other identifier: IIT2023022
• Study Type: interventional
• Target: 456
• Locations: 1 country
• Sites: 1

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.

Conditions

Transplant-Related Disorder

Outcome Measures

Primary Outcomes (1)

• Survival

  Overall survival during 1.5 years after transplantation

  1.5 years after transplantation

Secondary Outcomes (3)

• Non-relapse mortality rate

  1.5 years after transplantation

• Incidence of infections

  1.5 years after transplantation

• Immune cell count

  1.5 years after transplantation

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Health monitoring and regular return follow-up reminders BEHAVIORAL

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

Intervention group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Patients must be ≥ 16 years of age;
• \) Patients receiving haploidentical allo-HSCT;
• \) Patients have to sign an informed consent form before the start of the research procedure.

You may not qualify if:

• \) Tandem transplantation or multiple transplantations;
• \) Mental or other medical conditions that make the patients unable to comply with the research treatment and monitoring requirements;
• \) Patients who are ineligible for the study due to other factors, or will bear great risk if participating in the study.

Sponsors & Collaborators

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

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

Central Study Contacts

Yahui Feng, MS

CONTACT

022-23909051; fengyahui@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 17, 2024
• Study Start: February 29, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: August 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)