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RecruitingPhase 1NCT06809712

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

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

Sponsor

He Huang

Enrollment

29 participants

Start Date

Aug 4, 2022

Study Type

INTERVENTIONAL

Conditions

Hematologic Disease

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.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria5

  • 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 Criteria6

  • 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.

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Interventions

DRUGBusulfan (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);

DRUGCyclophosphamide (CTX)

Myeloablative conditioning: Cyclophosphamide (Cy，1.8g/m2, -5d, -4d) Cyclophosphamide is not used for reduced intensity conditioning

DRUGFludarabine (Fludara)

Myeloablative conditioning: Fludarabine (Flu，30 mg/m2/d IV -6d \~ -2d); Reduced intensity conditioning: Fludarabine (Flu，30mg/m2 /d IV -10d\~-5d);

DRUGSemustine (MeccNU)

For both myeloablative and reduced intensity conditioning: Semustine (MeCCNU: 250 mg/m2 orally-3d)

Locations(1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

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NCT06809712