Actively Recruiting
Evaluation of Cytomegalovirus and Epstein-Barr Virus Specific Immune Reformulation in Prophylaxis for Cytomegalovirus in Haploid Hematopoietic Stem Cell Transplantation
Led by The First Affiliated Hospital of Soochow University · Updated on 2024-08-15
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the immune system recovery specific to cytomegalovirus (CMV) and Epstein-Barr virus (EBV) in patients with hemopathy who undergo haploidentical hematopoietic stem cell transplantation (haplo-HSCT). The study focuses on how well the immune system reestablishes itself while patients receive preventative treatment against cytomegalovirus. This observational, single-center study aims to better understand immune responses in this patient group. The study involves testing participants' CMV and EBV specific cell-mediated immunity (CMI) before the conditioning treatment and at several points after transplantation: 30, 45, 60, 90, 120, and 180 days. These tests help track immune recovery and response over time. This study does not involve experimental drug treatments but monitors immune function as part of the transplant care process. Participants will be monitored for immune responses through blood tests at scheduled intervals. Researchers will measure key outcomes such as CMV and EBV CMI at 6 months post-transplant and track virus reactivation rates, survival, relapse, and complications like graft-versus-host disease up to one year after transplantation. The total follow-up period includes assessments up to 12 months to evaluate long-term immune status and patient outcomes.
CONDITIONS
Brief Title
Evaluation of CMV/EBV-CMI in Haploid HSCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with hemopathy
- Indication for haploidentical hematopoietic stem cell transplantation
- Receiving prophylaxis for cytomegalovirus
- Signed informed consent agreeing to study participation
You will not qualify if you...
- Any condition deemed unsuitable for the trial by the investigators
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.
1 visit (in-person)
Duration - 6 months
Participants undergo CMV/EBV-CMI testing before the conditioning regimen and at multiple time points after transplantation to assess immune response.
6 visits (in-person) including before conditioning and at 30, 45, 60, 90, 120, and 180 days after transplantation
Duration - 1 year
Participants are monitored for viral reactivation, survival outcomes, and transplant-related complications up to 1 year after transplantation.
Periodic visits up to 1 year after transplantation
Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
Research Team
F
Feng Chen, PhD
D
Depei Wu, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here