Higher-risk Myelodysplastic Syndromes
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGVenetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT
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
Sponsors
Navy General Hospital, Beijing
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient should, in the investigator's opinion, be able to meet all clinical trial requirements. * The patient is willing and able to adhere to the study visit schedule and other protocol requirements. * The patient should be diagnosed with higher risk MDS according to the standard criteria of the World Health Organization (WHO).
Exclusion criteria
* Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment. * Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 3 year | OS was defined as time from diagnosis to death from any cause or the last follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | 3 year | For patients in morphologic remission, documented relapse was considered progression. |
| Incidence of acute GVHD and chronic GVHD | 3 year | Incidence rate of acute GVHD and chronic GVHD |
| Non-relapse mortality (NRM) | 3 year | Non-relapse mortality (NRM) was defined as death from any cause not subsequent to relapse. |
| Graft-versus-host disease (GVHD)-free relapse-free survival(GRFS) | 3 year | Graft-versus-host disease (GVHD)-free relapse-free survival(GRFS) was defined as petients without GVHD and relapse |
Countries
China
Contacts
Primary ContactLiren Qian, PhD
Outcome results
None listed