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RECRUITING
NCT06809712
PHASE1

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

Sponsor: He Huang

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

29

Start Date

2022-08-04

Completion Date

2027-10-31

Last Updated

2025-02-05

Healthy Volunteers

No

Interventions

DRUG

Busulfan (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);

DRUG

Cyclophosphamide (CTX)

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

DRUG

Fludarabine (Fludara)

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

Locations (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China