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Recruiting NCT06809712

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

Phase I Interventional Hematologic Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Busulfan (Busulfex), Cyclophosphamide (CTX), Fludarabine (Fludara), Semustine (MeccNU).
Who it may be relevant to
Registry conditions: Hematologic Disease. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective Single-arm Trial on Human Leukocyte Antigen (HLA) Mismatched Unrelated Allogeneic Hematopoietic Stem Cell Transplantation

Overview

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.

Interventions

  • Drug Busulfan (Busulfex)
    Myeloablative conditioning: Busulfan (Bu，3.2 mg/kg/d IV -8d \~-6d); Reduced intensity conditioning: Busulfan (Bu，3.2 mg/kg/d IV -7d\~-5d);
  • Drug Cyclophosphamide (CTX)
    Myeloablative conditioning: Cyclophosphamide (Cy，1.8g/m2, -5d, -4d) Cyclophosphamide is not used for reduced intensity conditioning
  • Drug Fludarabine (Fludara)
    Myeloablative conditioning: Fludarabine (Flu，30 mg/m2/d IV -6d \~ -2d); Reduced intensity conditioning: Fludarabine (Flu，30mg/m2 /d IV -10d\~-5d);
  • Drug Semustine (MeccNU)
    For both myeloablative and reduced intensity conditioning: Semustine (MeCCNU: 250 mg/m2 orally-3d)

Primary outcome measures

  • Overall survival [Time frame: 1-year]
Secondary outcome measures (6)
  • Neutrophil engraftment rate [Time frame: 28-days]
  • Platelet engraftment rate [Time frame: 28-days]
  • GVHD [Time frame: 180 days and 2 year]
  • Relapse [Time frame: 1-year]
  • Progression-free survival [Time frame: 1-year]
  • Graft-versus-host disease (GVHD)-free, relapse-free survival (GRFS) [Time frame: 1-year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou

Identifiers

NCT: NCT06809712 · MMU-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗