NCT06809699

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: He Huang · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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".

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 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".

Conditions

• Hematologic Diseases

Interventions

Type	Name	Description
DRUG	Busulfan (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)
DRUG	Cyclophosphamide (CTX)	Cyclophosphamide is only used in myeloablative conditioning (Cy，1.8g/m2, -5d, -4d)
DRUG	Fludarabine (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）
DRUG	Semustine (MeCCNU)	For both myeloablative and reduced intensity conditioning: Semustine (MECCNU，250 mg/m2 orally-3d).

Timeline

• Start date: 2022-08-04
• Primary completion: 2026-10-31
• Completion: 2027-10-31
• First posted: 2025-02-05
• Last updated: 2025-02-05

Locations

1 site across 1 country: China