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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Yishan Ye, MD., PhD
yeyishan@hotmail.com
+8618268068056
Time Frame
Start Date: 2022-08-04
Estimated Completion Date: 2027-10-31
Participants
Target number of participants: 29
Treatments
Experimental: HLA mismatch
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.
Related Therapeutic Areas
Sponsors
Leads: He Huang

This content was sourced from clinicaltrials.gov

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