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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| more than 5/10 HLA-mismatched allo-HSCT | more than 5/10 HLA-mismatched allo-HSCT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beijing protocol | Combination Product | 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). |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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Patient with hematologic malignancy,unavailable with HLA matched donor or related haploidentical donor
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Wang, Prof. | Contact | 13552647384 | ywyw3172@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaojun Huang, Prof. | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deparment of Hematology, Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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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 |
| Participants will be followed for an expected average of 1 years |