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

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

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 Overview

• Status: Recruiting
• Conditions: Hematologic Malignancy; Stem Cell Transplant Complications
• Intervention / Treatment: Combination product: Beijing protocol

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 Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Yu Wang, Prof.; Phone Number: 13552647384; Email: ywyw3172@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Deparment of Hematology, Peking University People's Hospital
      • Contact: Xiaojun Huang, doctor; Phone Number: 8601088326666; Email: xjrm@medmail.com.cn
      • Principal Investigator: Xiaojun Huang, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient with hematologic malignancy，unavailable with HLA matched donor or related haploidentical donor

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

more than 5/10 HLA-mismatched allo-HSCT

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Engraftment rate	The success rate of engraftment after transplantation	Participants will be followed for an expected average of 1 years

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Principal Investigator: Xiaojun Huang, Prof., Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: June 19, 2023
• First Submitted That Met QC Criteria: June 19, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Hematologic Malignancy; allogenetic hematopoietic stem cell transplant; HLA locus
• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms
• Other Study ID Numbers: Highly HLA mismatched HSCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No