Beijing Protocol in Patients Receiving More Than 5/10 HLA-mismatched Allo-HSCT

Recruiting

• Conditions: Hematologic Malignancy; Stem Cell Transplant Complications
• Interventions: Combination Product: Beijing protocol

• Registration Number: NCT05921318
• Lead Sponsor: Peking University People's Hospital

Brief Summary

The aim of the study is to evaluate the efficacy and safety of Beijing protocol in malignant haematologic disease patients receiving more than 5/10 HLA-mismatched allo-HSCT.

Detailed Description

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a potentially curative procedure for patients with hematological malignancies.Donor-recipient human leukocyte antigen (HLA) compatibility plays a key role in successful allo-HSCT as HLA-matching has a direct impact on the risk of GvHD, non-relapse mortality (NRM), and survival. Suitable, matched or haploidentical donors are not always available or accessible, even in the era of the international registries.Therefore, there is a need for new strategies that could negate the barrier of HLA-mismatching, allowing allo-HSCT from traditionally prohibitive highly mismatched donors.The aim of the study is to evaluate the efficacy and safety of Beijing protocol in malignant haematologic disease patients receiving more than 5/10 HLA-mismatched allo-HSCT.

Study Timeline

• Status Verified: 2023-06
• Study Start: 2023-06-01
• Study First Submitted: 2023-06-19
• Study First Submitted QC: 2023-06-19
• Last Update Submitted: 2023-06-19
• Study First Posted: 2023-06-27
• Last Update Posted: 2023-06-27
• Primary Completion: 2024-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• hematologic malignancy patients
• patients eligible for the transplantation of allogeneic hematopoietic stem cells;
• patients unavailable with HLA matched donor or related haploidentical donor
• voluntary participation in this study and signing the informed consent form.

Exclusion Criteria

• Patients with the severe infections;
• Pregnant or lactating women
• Patients who are not eligible for hematopoietic stem cell transplantation;
• Patients who are enrolled in other clinical trials within 1 month;
• Patients who may not be able to complete the study for other reasons, or may be considered by the investigator not suitable to participate in the study;
• Patients unable to properly understand or refusing to accept the informed consent form.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
more than 5/10 HLA-mismatched allo-HSCT	Beijing protocol	more than 5/10 HLA-mismatched allo-HSCT

Primary Outcome Measures

Name	Time	Method
1-year LFS	Participants will be followed for an expected average of 1 years	defined as disease relapse, disease progression or death (whichever occurs first) within 1 year from the day the patient receives transplantation.

Secondary Outcome Measures

Name	Time	Method
1-year OS	Participants will be followed for an expected average of 1 years	defined as survival rate within 1 year from the day the patient receives transplantation, calculated based on death from any cause.
1-year TRM	Participants will be followed for an expected average of 1 years	defined as death from any cause other than disease relapse within 1 year from the day the patient receives transplantation.

Trial Locations

Locations (1)

Deparment of Hematology, Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China