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

He Huang

Status and phase: Enrolling; Phase 1

Conditions: Hematologic Diseases

Treatments: Drug: Busulfan (Busulfex); Drug: Fludarabine (Fludara); Drug: Semustine (MeCCNU); Drug: Cyclophosphamide (CTX)

Study type: Interventional

Funder types: Other

Identifiers

NCT06809699

MMR-001

Details and patient eligibility

About

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".

Full 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 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".

Enrollment: 29 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 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 (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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

HLA-mismatch related

Experimental group

Description:

The myeloablative conditioning is used when the patient is below 50 and with an HCT-CI\<2. The reduced intensity conditioning is used when the patient is over 50 or with an HCT-CI≥2.

Treatment:

Drug: Cyclophosphamide (CTX)

Drug: Semustine (MeCCNU)

Drug: Fludarabine (Fludara)

Drug: Busulfan (Busulfex)