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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
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
Navy General Hospital
Beijing, Beijing Municipality, China
RECRUITINGOverall Survival
OS was defined as time from diagnosis to death from any cause or the last follow-up
Time frame: 3 year
Progression Free Survival (PFS)
For patients in morphologic remission, documented relapse was considered progression.
Time frame: 3 year
Incidence of acute GVHD and chronic GVHD
Incidence rate of acute GVHD and chronic GVHD
Time frame: 3 year
Non-relapse mortality (NRM)
Non-relapse mortality (NRM) was defined as death from any cause not subsequent to relapse.
Time frame: 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
Time frame: 3 year
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