A Prospective Single-arm Trial on Human Leukocyte Antigen (HLA) Mismatched Related 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 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.

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 with no available related human leukocyte antigen (HLA) identical sibling donors;

• No available donor with HLA high-resolution typing ≥ 9/10 or those who have difficulty finding donors due to urgent medical conditions;

• No suitable HLA matching haploidentical donor available;

• There is a suitable donor with mismatched HLA typing;

• 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
Yanmin Zhao, MD., PhD
yanminzhao@zju.edu.cn
+86 87236706
Backup
Yishan Ye, MD., PhD
yeyishan@zju.edu.cn
Time Frame
Start Date: 2022-08-04
Estimated Completion Date: 2027-10-31
Participants
Target number of participants: 29
Treatments
Experimental: HLA-mismatch related
The myeloablative conditioning is used when the patient is below 50 and with an HCT-CI\<2. The reduced intensity conditioning is used when the patient is over 50 or with an HCT-CI≥2.
Related Therapeutic Areas
Sponsors
Leads: He Huang

This content was sourced from clinicaltrials.gov

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