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

He Huang

Status and phase: Enrolling; Phase 1

Conditions: Hematologic Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06809712

MMU-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 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.

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 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.

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;
• 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.

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

Experimental group

Description:

Myeloablative conditioning regimen was used when patient is below 50 and with a HCT-CI score \<2; Reduced intensity conditioning regimen was used when patient is over 50 or with HCT-CI score ≥2.

Treatment:

Drug: Fludarabine (Fludara)

Drug: Busulfan (Busulfex)

Drug: Cyclophosphamide (CTX)

Drug: Semustine (MeccNU)