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 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.

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 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 it's running

• 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

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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.