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

Hematologic Malignancy Clinical Trial

Official title:

The Safety and Efficiency of Beijing Protocol in Malignant Hematologic Disease Patients Receiving More Than 5/10 HLA-mismatched Allo-HSCT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05921318
• Other study ID #: Highly HLA mismatched HSCT
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: May 31, 2026

Study information

• Verified date: June 2023
• Source: Peking University People's Hospital
• Contact: Yu Wang, Prof.
• Phone: 13552647384
• Email: ywyw3172[@]sina.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Malignancy
• Hematologic Neoplasms
• Neoplasms
• Stem Cell Transplant Complications

Intervention

Combination Product:
• Beijing protocol
For patients <55 years and HCT-CI= 3:Ara-C(4g/m2/day,-9 days),Bu(9.6mg/kg,-8 days to -6 days),Cy(1,800mg/m2/day,-5 days to -4 days),semustine(250mg/m2,-3 days),ATG(7.5-10 mg/kg,-5 to -2 days) For patients = 55 years or HCI-CI>3:Ara-C(2g/m2/day,-10 days to -9 days),Bu(9.6mg/kg,-8 days to -6 days),Flu(30mg/m2/day,-6 days to -2 days),Cy(1,000mg/m2/day,-5 days to -4 days),semustine(250mg/m2,-3 days),ATG(7.5-10 mg/kg,-5 to -2 days).

Locations

Country	Name	City	State
China	Deparment of Hematology, Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse event	The incidence rate of acute GVHD, chronic GVHD, CMV activation, EBV activation after transplantation	Participants will be followed for an expected average of 1 years
Other	Engraftment rate	The success rate of engraftment after transplantation	Participants will be followed for an expected average of 1 years
Primary	1-year LFS	defined as disease relapse, disease progression or death (whichever occurs first) within 1 year from the day the patient receives transplantation.	Participants will be followed for an expected average of 1 years
Secondary	1-year OS	defined as survival rate within 1 year from the day the patient receives transplantation, calculated based on death from any cause.	Participants will be followed for an expected average of 1 years
Secondary	1-year TRM	defined as death from any cause other than disease relapse within 1 year from the day the patient receives transplantation.	Participants will be followed for an expected average of 1 years