Health Trials

Human Leukocyte Antigen (HLA) Mismatched Unrelated Allogeneic Hematopoietic Stem Cell Transplantation

ConditionHematologic Disease
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 highly mismatched unrelated HLA mismatched donors. Ultimately, an unrelated human leukocyte antigen (HLA) mismatched allo HSCT transplantation plan will be established to improve the disease prognosis of this group of patients and truly enter the era of "everyone has a donor" for allo HSCT.

Eligibility criteria

Qualifiers

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;

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 Performance Status (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 group

Sponsors and collaborators

He Huang

Lead sponsor

Zhejiang University

Sponsor institution

Source ClinicalTrials.gov