HLA mismatched stem cell transplantation for hematologic diseases
A Prospective Single-arm Trial on Human Leukocyte Antigen (HLA) Mismatched Unrelated Allogeneic Hematopoietic Stem Cell Transplantation
This study is testing a new stem cell transplant approach for patients with blood cancers who can't find matching donors to see if it can improve their chances of recovery.
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) |
| Trial ID | NCT06809712 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 lack suitable donors. The trial will utilize highly mismatched unrelated HLA donors to establish a transplantation plan that could improve disease prognosis. By focusing on patients who cannot find suitable donors, the study seeks to ensure that more individuals have access to potentially life-saving treatments. The interventions include Busulfan, Cyclophosphamide, Fludarabine, and Semustine.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with hematological malignancies needing stem cell transplantation and lacking suitable donors.
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 provide a viable transplantation option for patients who currently have no suitable donor matches.
How similar studies have performed: While the use of HLA mismatched donors is a novel approach, similar studies have shown promise in expanding donor options for patients in need of stem cell transplants.
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; * Non blood donors without human leukocyte antigen (HLA) high-resolution typing ≥ 9/10, or those who have difficulty finding non blood donors due to urgent medical conditions; * No suitable HLA matching haploidentical donor available; * There are suitable unrelated HLA mismatched (HLA high-resolution typing\<9/10) donors; * 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 Performance Status (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 hematopoietic stem cell transplantation (HSCT) contraindications.
Where this trial is running
Hangzhou
- The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, China (Recruiting)
Study contacts
- Study coordinator: Yishan Ye, MD., PhD
- Email: yeyishan@hotmail.com
- Phone: +8618268068056
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.