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

NCT06809712 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2025-02-05

No results posted yet for this study

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.

Conditions

  • Hematologic Disease

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)

Sponsors & Collaborators

  • He Huang

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-04
Primary Completion
2026-10-31
Completion
2027-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06809712 on ClinicalTrials.gov