Beijing Protocol in Patients Receiving More Than 5/10 HLA-mismatched Allo-HSCT
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| more than 5/10 HLA-mismatched allo-HSCT 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).
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Outcome Measures
Primary Outcome Measures
- 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
- 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.
Other Outcome Measures
- Adverse event [Participants will be followed for an expected average of 1 years]
The incidence rate of acute GVHD, chronic GVHD, CMV activation, EBV activation after transplantation
- Engraftment rate [Participants will be followed for an expected average of 1 years]
The success rate of engraftment after transplantation
Eligibility Criteria
Criteria
Inclusion Criteria:
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hematologic malignancy patients
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patients eligible for the transplantation of allogeneic hematopoietic stem cells;
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patients unavailable with HLA matched donor or related haploidentical donor
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voluntary participation in this study and signing the informed consent form.
Exclusion Criteria:
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Patients with the severe infections;
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Pregnant or lactating women
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Patients who are not eligible for hematopoietic stem cell transplantation;
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Patients who are enrolled in other clinical trials within 1 month;
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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;
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Patients unable to properly understand or refusing to accept the informed consent form.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Deparment of Hematology, Peking University People's Hospital | Beijing | Beijing | China | 100044 |
Sponsors and Collaborators
- Peking University People's Hospital
Investigators
- Principal Investigator: Xiaojun Huang, Prof., Peking University People's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Highly HLA mismatched HSCT