RecruitingPhase 1NCT06809699

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

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

Sponsor

He Huang

Enrollment

29 participants

Start Date

Aug 4, 2022

Study Type

INTERVENTIONAL

Conditions

Hematologic Diseases

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 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

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 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;
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 (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 HSCT contraindications.

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Interventions

DRUGBusulfan (Busulfex)

For myeloablative conditioning: Busulfan (Bu，3.2 mg/kg/d IV -8d \~-6d) For reduced intensity conditioning: (Bu，3.2 mg/kg/d IV -7d\~-5d)

DRUGCyclophosphamide (CTX)

Cyclophosphamide is only used in myeloablative conditioning (Cy，1.8g/m2, -5d, -4d)

DRUGFludarabine (Fludara)

For myeloablative conditioning: Fludarabine (Flu，30 mg/m2/d IV -6d \~ -2d) For 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).