HLA mismatched stem cell transplantation for hematologic diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.