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The goal of this phase 1/2 trial is to test the safety and efficacy of Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT in treating patients with higher-risk MDS.
The investigators will evaluate 2 year overall survival(OS) after transplantation in patients with higher-risk MDS. Progression free survival (PFS), incidence of acute GVHD, non-relapse mortality (NRM), graft-versus-host disease (GVHD)-free relapse-free survival(GRFS), and incidence of chronic GVHD at 1 and 2 years after transplantation will be counted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT | Experimental | Patients were treated by Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT | Drug | Patients were treated by VA Conditioning Regimen Allo-HSCT: Venetoclax 100mg po qd d1, 200mg po qd d2, 400mg po qd d3-14; Azacytidine 75 mg/m2 subcutaneous injection qd d1-7, donor stem cells infused from d9 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | OS was defined as time from diagnosis to death from any cause or the last follow-up | 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | For patients in morphologic remission, documented relapse was considered progression. | 3 year |
| Incidence of acute GVHD and chronic GVHD | Incidence rate of acute GVHD and chronic GVHD |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liren Qian, PhD | Contact | +861066947192 | qlr2007@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Liren Qian, PhD | Navy General Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Navy General Hospital | Recruiting | Beijing | Beijing Municipality | 100048 | China |
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| ID | Term |
|---|---|
| C579720 | venetoclax |
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|
| 3 year |
| Non-relapse mortality (NRM) | Non-relapse mortality (NRM) was defined as death from any cause not subsequent to relapse. | 3 year |
| Graft-versus-host disease (GVHD)-free relapse-free survival(GRFS) | Graft-versus-host disease (GVHD)-free relapse-free survival(GRFS) was defined as petients without GVHD and relapse | 3 year |