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Recruiting NCT06208137

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

No phase Interventional Transplant-Related Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Health monitoring and regular return follow-up reminders.
Who it may be relevant to
Registry conditions: Transplant-Related Disorder. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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.

Overview

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

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

Primary outcome measures

  • Survival [Time frame: 1.5 years after transplantation]
Secondary outcome measures (3)
  • Non-relapse mortality rate [Time frame: 1.5 years after transplantation]
  • Incidence of infections [Time frame: 1.5 years after transplantation]
  • Immune cell count [Time frame: 1.5 years after transplantation]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

China · 1 center
  • Institute of Hematology & Blood Diseases Hospital — Tianjin

Identifiers

NCT: NCT06208137 · IIT2023022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗