Actively Recruiting

Phase Not Applicable
Age: 16Years +
All Genders
ID06208137

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.

Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2024-08-13

456

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating how well the Composite Immune Risk Score (CIRS) works for patients who have received allogeneic hematopoietic stem cell transplantation. The study aims to see if this score can effectively assess and guide immune system recovery after transplant in a real-world clinical setting. The research is a prospective, multicenter, randomized controlled study focusing on patients with transplant-related disorders. Participants are divided into two groups. One group receives health monitoring along with regular reminders to return for blood tests and follow-up visits up to one year after transplant. Physicians use the CIRS to assess the immune risk level of patients between 91 and 180 days post-transplant. The other group only receives reminders to test their immune status between 120 and 180 days after transplantation. During the study, participants will be monitored for survival and immune recovery for 1.5 years after transplantation. Researchers will collect data on survival rates, non-relapse mortality, infections, and immune cell counts. The study involves regular follow-up visits and blood tests to track immune status and overall health. Participants must be at least 16 years old and have undergone haploidentical allo-HSCT to join the study.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must be 16 years of age or older
  • Patients receiving haploidentical allogeneic hematopoietic stem cell transplantation (allo-HSCT)
  • Patients must sign an informed consent form before starting the study
Not Eligible

You will not qualify if you...

  • Patients who have had tandem transplantation or multiple transplantations
  • Patients with mental or medical conditions that prevent compliance with treatment and monitoring
  • Patients deemed ineligible or at great risk if participating in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Outpatient Treatment

Duration - Up to 1 year post-transplant

Participants receive health monitoring and reminders for blood tests and follow-up visits until 1 year post-transplant.

Regular reminders and blood test visits during the first year after transplantation

Trial Site Locations

Total: 1 location

1

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China, 300020

Actively Recruiting

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Research Team

Y

Yahui Feng, MS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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