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Objectives 2.1 Primary objectives
1) To observe and compare incidence and severity of aGVHD and cGVHD between the two arms within 2 years after transplantation.
2) To observe and compare the engraftment rate between the two arms. 3) To observe and compare the incidence of infections between the two arms. 2.2 Secondary objectives
3. Study design 3.1 Principle of design: prospective, randomized, control, open label 3.2 Subjects: patients with SAA undergoing allogeneic HSCT 3.3 Grouping: In this study, central randomization was used for random enrolment (1:1). After signing the informed consent, patients were randomized into rituximab conditioning group (test group) or non- rituximab conditioning group (control group). Treatment was assigned on a randomized basis according to a 1:1 ratio. The test group and the control group each will include 100 cases.
3.4 Study schedule: This clinical research is to be completed from September 2020 to September 2023.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATG arm (control group) | Active Comparator | 4.2.1 Matched sibling donor 1) ATG arm (control group) Fludarabine 30mg/m2/d×6d(-7d ~ -2d)+ Cyclophosphamide 50mg/kg/d×2d (-4d ~ -3d)+ ATG 2.5mg/kg/d×5d(-8d ~ -4d) 4.2.2 Unrelated donor and haploidentical donor 1) ATG arm (control group) Busulfan 3.2 mg/kg/d(0.8 mg/kg,q6h)×2d(-7d ~ -6d) + Cyclophosphamide 50mg/kg/d×4d (-5d ~ -2d)+ ATG 2.5mg/kg/d×4d(-5d ~ -2d) |
|
| ATG + CD20 monoclonal antibody (test arm) | Experimental | 4.2.1 Matched sibling donor 2) ATG + CD20 monoclonal antibody (test arm) Fludarabine 30mg/m2/d×6d(-7d ~ -2d) + Cyclophosphamide 50mg/kg/d×2d (-4d ~ -3d)+ ATG 2.5mg/kg/d×5d(-8d ~ -4d)+ CD20 monoclonal antibody 375mg/m2, -1d 4.2.2 Unrelated donor and haploidentical donor 2) ATG + CD20 monoclonal antibody (test arm) Busulfan 3.2 mg/kg/d(0.8 mg/kg,q6h)×2d(-7d ~ -6d) + Cyclophosphamide 50mg/kg/d×4d (-5d ~ -2d)+ ATG 2.5mg/kg/d×4d(-5d ~ -2d)+ CD20 monoclonal antibody 375mg/m2, -1d |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD20 monoclonal antibody | Drug | 4.2 Conditioning Regimen 4.2.1 Matched sibling donor
4.2.2 Unrelated donor and haploidentical donor
|
| Measure | Description | Time Frame |
|---|---|---|
| GVHD incidence | GVHD incidence, location and grade. Infection incidence and recurrence rate. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Infection incidence | Cumulative incidence of infection post-transplant | 2 years |
| GVHD-free survival rate | defined by the percentage of patients who are alive without evidence of moderate or severe chronic GVHD at 2 year |
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Inclusion Criteria:
Subjects eligible for inclusion in this study must meet all of the following criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| depei wu | Contact | 67781856 | 0512 | wudepei@suda.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| depei wu | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215215 | China |
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| ID | Term |
|---|---|
| D000741 | Anemia, Aplastic |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000080983 | Bone Marrow Failure Disorders |
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| ID | Term |
|---|---|
| C527563 | 188Re-anti-CD20 monoclonal antibody |
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|
|
| ATG | Drug | 4.2 Conditioning Regimen 4.2.1 Matched sibling donor
4.2.2 Unrelated donor and haploidentical donor
|
|
| 2 years |
| transplant related mortality | Defined as the number of days from the date of transplant to the date of death related to transplant | 2 years |
| overall survival rate | OS is defined as the number of days from the date of transplant to the date of death | 2 years |
| D001855 | Bone Marrow Diseases |