Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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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