Clinical trial NCT06809712: Human Leukocyte Antigen (HLA) Mismatched Unrelated Allogeneic Hematopoietic Stem Cell Transplantation
Official title: A Prospective Single-arm Trial on Human Leukocyte Antigen (HLA) Mismatched Unrelated Allogeneic Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hematologic Disease
Keywords: Hematopoietic cell transplantation
HLA mismatch
Hematologic diseases
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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: 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.

Primary outcomes:
measure: Overall survival
timeFrame: 1-year
Secondary outcomes:
measure: Neutrophil engraftment rate
timeFrame: 28-days
measure: Platelet engraftment rate
timeFrame: 28-days
measure: GVHD
timeFrame: 180 days and 2 year
measure: Relapse
timeFrame: 1-year
measure: Progression-free survival
timeFrame: 1-year
measure: Graft-versus-host disease (GVHD)-free, relapse-free survival (GRFS)
timeFrame: 1-year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
Study officials:
References: