Actively Recruiting
Second Haploidentical Transplantation with Modified Regimen for Graft Failure After the First Allogeneic Stem Cell Transplantation
Led by Peking University People's Hospital · Updated on 2024-11-29
12
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Graft failure is a serious complication that can occur after an allogeneic stem cell transplantation, often requiring a second transplantation. Researchers are evaluating a modified regimen designed to improve blood cell recovery after a second haploidentical stem cell transplantation for patients experiencing graft failure. This prospective, single-arm study aims to assess the safety and effectiveness of this new approach. The study involves a second allogeneic stem cell transplantation with a modified conditioning regimen including fludarabine, cyclophosphamide, and rabbit antithymocyte globulin. Additional treatments include graft-versus-host disease (GVHD) prevention with cyclosporine A, mycophenolate mofetil, and anti-CD25 monoclonal antibody. When possible, a different donor will be selected for the second transplant. Participants will be monitored for neutrophil engraftment by 28 days and platelet engraftment by 100 days after the second transplantation. The study will also follow transplant-related mortality, GVHD, overall survival, leukemia-free survival, and relapse incidence for about one year. Safety, effectiveness, and blood recovery will be carefully evaluated throughout the study period.
CONDITIONS
Brief Title
Modified Second Haplo-transplantation for Graft Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with hematological malignancies such as AML, CML, MDS, lymphoma, or similar
- Experienced graft failure after the first allogeneic stem cell transplantation
- Time from first transplantation to second transplantation is less than 180 days
- Age 14 years or older
You will not qualify if you...
- Have active infections
- Have active graft-versus-host disease (GVHD)
- Have organ dysfunction: liver injury (total bilirubin above 2 times upper limit), kidney injury (creatinine above 1.5 times upper limit), heart injury (ejection fraction below 50% or symptomatic heart failure)
- Eastern Cooperative Oncology Group (ECOG) score greater than 2
- Expected life expectancy less than 30 days
- Unable to cooperate with study procedures
- Any other condition deemed unsuitable 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 - Up to 28 days or until neutrophil engraftment
Participants receive a second haploidentical stem cell transplantation with a modified conditioning regimen and GVHD prophylaxis.
Multiple visits during transplantation period
Duration - Up to 1 year
Participants are monitored for engraftment, graft-versus-host disease, treatment-related mortality, overall survival, and relapse-free survival for up to 1 year after transplantation.
Regular visits over 1 year
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
Y
Yu-qian Sun, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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