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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hematologic Malignancy, Stem Cell Transplant Complications

Intervention / Treatment
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* Combination Product: Beijing protocol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| more than 5/10 HLA-mismatched allo-HSCT<br>more than 5/10 HLA-mismatched allo-HSCT | Combination Product: Beijing protocol<br>* 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).<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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allogenetic hematopoietic stem cell transplant, HLA locus, Hematologic Malignancy