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

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.

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06208137

Enrollment

456

Registered

2024-01-17

Start date

2024-02-29

Completion date

2028-04-01

Last updated

2024-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transplant-Related Disorder

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.

Interventions

BEHAVIORALHealth monitoring and regular return follow-up reminders

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Survival	1.5 years after transplantation	Overall survival during 1.5 years after transplantation

Secondary

Measure	Time frame	Description
Non-relapse mortality rate	1.5 years after transplantation	Non-relapse mortality rate during 1.5 years after transplantation
Incidence of infections	1.5 years after transplantation	Infections during 1.5 years after transplantation
Immune cell count	1.5 years after transplantation	Data on immune cell count will be collected during 1.5 years after transplantation

Countries

China

Contacts

Primary ContactYahui Feng, MS

fengyahui@ihcams.ac.cn022-23909051

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026