Human Leukocyte Antigen (HLA) Mismatched Related Allogeneic Hematopoietic Stem Cell Transplantation
ConditionHematologic Diseases
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorHe Huang
About this trial
This study is a single center, prospective, single arm exploratory clinical trial that includes patients with hematological malignancies who are indicated for allogeneic hematopoietic stem cell transplantation (allo HSCT) but lack suitable donors. This project plans to use human leukocyte antigen (HLA) mismatched donors. Ultimately, a HLA mismatched allo HSCT transplantation plan will be established to improve the disease prognosis of these patients and truly enter the era of "everyone has a donor".
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Busulfan (Busulfex)
- Cyclophosphamide (CTX)
- Fludarabine (Fludara)
- Semustine (MeCCNU)
Treatment groups
29 Participants
are divided into 1 treatment groupSponsors and collaborators
He Huang
Lead sponsor
Zhejiang University
Sponsor institution
Source ClinicalTrials.gov