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

Transplant-Related Disorder Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06208137
• Other study ID #: SKIRT-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: April 1, 2028

Study information

• Verified date: March 2024
• Source: Institute of Hematology & Blood Diseases Hospital, China
• Contact: Yahui Feng, MS
• Phone: 022-23909051
• Email: fengyahui[@]ihcams.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 456
• Est. completion date: April 1, 2028
• Est. primary completion date: October 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Transplant-Related Disorder

Intervention

Behavioral:
• Health monitoring and regular return follow-up reminders
Health monitoring & reminders for blood tests and follow-up visits until 1 year post-transplant

Locations

Country	Name	City	State
China	Institute of Hematology & Blood Diseases Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Hematology & Blood Diseases Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Overall survival during 1.5 years after transplantation	1.5 years after transplantation
Secondary	Non-relapse mortality rate	Non-relapse mortality rate during 1.5 years after transplantation	1.5 years after transplantation
Secondary	Incidence of infections	Infections during 1.5 years after transplantation	1.5 years after transplantation
Secondary	Immune cell count	Data on immune cell count will be collected during 1.5 years after transplantation	1.5 years after transplantation