Actively Recruiting
A Prospective Single-arm Trial on Human Leukocyte Antigen (HLA) Mismatched Related Allogeneic Hematopoietic Stem Cell Transplantation
Led by He Huang · Updated on 2025-02-05
29
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a type of stem cell transplantation called human leukocyte antigen (HLA) mismatched allogeneic hematopoietic stem cell transplantation in patients with blood cancers who need this transplant but do not have suitable donors. This exploratory trial aims to develop a transplantation plan using donors with HLA mismatches to improve disease outcomes and expand donor availability. The study uses different conditioning treatments based on patient age and health status. Patients under 50 with low comorbidity receive myeloablative conditioning including drugs like Busulfan, Cyclophosphamide, Fludarabine, and Semustine, while those over 50 or with higher comorbidity receive reduced intensity conditioning with adjusted drug schedules. The treatment involves a single arm design using HLA mismatched related donors. Participants will be monitored for outcomes such as overall survival after one year, engraftment rates of neutrophils and platelets at 28 days, relapse rates, progression-free survival, and graft-versus-host disease-free survival. Assessments include clinical evaluations and laboratory tests to track transplant success and safety. The study spans several years and aims to improve transplant options for patients lacking suitable donors.
CONDITIONS
Brief Title
Human Leukocyte Antigen (HLA) Mismatched Related Allogeneic Hematopoietic Stem Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 to 60 years with hematological malignancies needing hematopoietic stem cell transplantation
- No available related HLA identical sibling donor
- No available donor with HLA high-resolution typing of 9/10 or greater, or urgent medical condition making donor search difficult
- No suitable HLA matching haploidentical donor available
- Suitable donor with mismatched HLA typing is available
- Signed informed consent by patient or legal representative before study start
You will not qualify if you...
- Severe liver dysfunction (alanine aminotransferase >2.5 times upper limit of normal)
- Severe kidney dysfunction (blood creatinine >1.5 times upper limit of normal)
- Severe cardiopulmonary dysfunction (NYHA III/IV heart function, ejection fraction <50%, severe obstructive or restrictive ventilation dysfunction)
- Active infections
- Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or higher
- Active secondary tumors
- Severe central nervous system or mental illness preventing autonomous consent
- Other contraindications for allogeneic hematopoietic stem cell transplantation
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 - Approximately 2 weeks for conditioning and transplantation
Participants receive conditioning chemotherapy followed by HLA mismatched related allogeneic hematopoietic stem cell transplantation to treat hematological malignancies.
Multiple visits during conditioning and transplantation period
Duration - Up to 1 year
Participants are monitored for survival and disease progression after transplantation.
Regular follow-up visits during the first year post-transplantation
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China, China, 310003
Actively Recruiting
Research Team
Y
Yanmin Zhao, MD., PhD
Y
Yishan Ye, MD., PhD
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