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This is a prospective, single-center, single-arm, phase 2 study. This study aims to evaluate the efficacy and safety of anti-lymphocyte globulin plus herombopag in combination with the reduced dose of cyclophosphamide (hypo-CASH) for severe aplastic anemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hypo-CASH | Experimental | ALG/CsA and herombopag and reduced dose of cyclophosphamide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduced dose of cyclophosphamide combined with standard immunosuppressive therapy | Drug | Severe aplastic anemia patients will receive a daily dose of Anti-lymphocyte globulin (25mg/kg) for the initial five days at the beginning of the treatment. Cyclosporine will be administered daily at a dosage of 3-5mg/kg. Herombopag will be administered daily at a dosage of 15mg starting from the first day of treatment and continuing for a duration of six months. Cyclophosphamide (20mg/kg) will be administered on days 15-16. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | Percentage of patients with hematological response. Hematological response includes complete rate, near complete rate(CR), very good partial response(VGPR), good partial response(GPR) and partial response(PR). | Within 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Superior response rate | Percentage of patients with superior response, including CR, VGPR and GPR. | With in 6 months |
| Overall response rate | Percentage of patients with hematological response. Hematological response includes complete rate, near complete rate(CR), very good partial response(VGPR), good partial response(GPR) and partial response(PR). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hong Pan, MD | Contact | 15822458611 | panhong@ihcams.ac.cn | |
| Jingyu Zhao, MPH | Contact | 13752253515 | zhaojingyu@ihcams.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Red Blood Cell Disorders Center and Regenerative Medicine Center | Recruiting | Tianjin | Tianjin Municipality | 301617 | China |
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|
| With in 6 months |
| Incidence of the adverse event | Use Common Terminology Criteria for Adverse Events (CTCAE) Version 5 to assess the adverse event | Within 6 months |
| Time to achieve robust superior response | Within 6 months |
| First time to response | Within 6 months |
| ID | Term |
|---|---|
| D000741 | Anemia, Aplastic |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000080983 | Bone Marrow Failure Disorders |
| D001855 | Bone Marrow Diseases |
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