HLA mismatched stem cell transplantation for hematologic diseases
A Prospective Single-arm Trial on Human Leukocyte Antigen (HLA) Mismatched Related Allogeneic Hematopoietic Stem Cell Transplantation
This study is testing if using stem cells from donors who aren't a perfect match can help people with blood cancers get the treatment they need when they can't find a suitable donor.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 29 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, China) |
| Trial ID | NCT06809699 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a single center, prospective, single arm exploratory study aimed at patients with hematological malignancies who require allogeneic hematopoietic stem cell transplantation but do not have suitable donors. The study will utilize human leukocyte antigen (HLA) mismatched donors to establish a transplantation plan that could enhance disease prognosis. The trial will involve administering specific chemotherapy agents, including Busulfan, Cyclophosphamide, Fludarabine, and Semustine, to prepare patients for the transplant. The ultimate goal is to ensure that every patient has access to a donor, even in the absence of perfectly matched ones.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients aged 18-60 with hematological malignancies who require stem cell transplantation but do not have a suitable HLA-matched donor.
Not a fit: Patients with severe liver or kidney dysfunction, active infections, or significant cardiopulmonary issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment options and outcomes for patients with hematologic diseases who lack suitable stem cell donors.
How similar studies have performed: While the use of HLA mismatched donors is a novel approach, similar studies have shown promise in expanding donor availability for stem cell transplantation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (18-60 years old) with hematological malignancies and indications for hematopoietic stem cell transplantation with no available related human leukocyte antigen (HLA) identical sibling donors; * No available donor with HLA high-resolution typing ≥ 9/10 or those who have difficulty finding donors due to urgent medical conditions; * No suitable HLA matching haploidentical donor available; * There is a suitable donor with mismatched HLA typing; * The subjects or their legal representatives shall sign an informed consent form before the start of the clinical study. Exclusion Criteria: * Patients with severe liver and kidney function (alanine aminotransferase\>2.5 times the upper limit of normal, blood creatinine\>1.5 times the upper limit of normal) and cardiopulmonary dysfunction (New York Heart Association (NYHA) III/IV heart function, ejection fraction\<50%, severe obstructive or restrictive ventilation dysfunction); * Merge active infections; * Eastern Cooperative Oncology Group (ECOG) score ≥ 2 points; * Secondary tumors with merged activity; * Severe central nervous system or mental illness leading to the inability to autonomously choose to enter or exit clinical trials; * Combine other allo HSCT contraindications.
Where this trial is running
Hangzhou, China
- The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, China, China (Recruiting)
Study contacts
- Study coordinator: Yanmin Zhao, MD., PhD
- Email: yanminzhao@zju.edu.cn
- Phone: +86 87236706
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.