The main objective of the study is to evaluate the efficacy and safety of maintenance therapy with hypomethylating agent and Venetoclax to improve leukemia free survival for high-risk myeloid malignancies after allogeneic hematopoietic stem cell transplantation .
This is a prospective single-arm study. Patients with high-risk AML or MDS aged between 18-70 years old will enroll in the study. They will be given hypomethylating agents (azacytidine 32mg/m2 or decitabine 5mg/m2) for 5 days and venetoclax 400mg/d for 7 days after allogeneic hematopoietic stem cell transplantation. The maintenance therapy will start from 60th days posttransplant, repeated every 28 days until up to 1-year posttransplant. The 1-year leukemia-free survival rate,1-year cumulative recurrence rate, and 1-year overall survival will be analyzed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
78
Participants will receive maintenance therapy with venetoclax and azacitidine or decitabine after allogeneic stem cell transplantation. Azacitidine will be administered once daily subcutaneously (32mg/m2/d) on days 1-5, and venetoclax will be administered once daily orally (400mg/day) on days 1-7. If the patient is refractory or allergic to azacitidine, they will receive decitabine. Decitabine will be administered intravenously (5mg/m2/d) on days 1-5. If the patient is treated with CYP450 inhibitors(such as posaconazole or voriconazole), the dose of venetoclax will reduce to 100 mg once daily on days 1-7. Maintenance therapy will start from the 60th to 120th days after allogeneic hematopoietic stem cell transplantation and repeat every 28 days for up to 10 cycles within the first year after transplantation.
azacytidine 32mg/m2 or decitabine 5mg/m2
Shanghai Jiao Tong University School of Medicine Affilated Shanghai General Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGLeukemia-free survival (LFS) time
Summary statistics for LFS time will be computed for all patients.
Time frame: From the date of transplantation, assessed up to 1 year after transplantation.
Cumulative incidence of relapse
Use the method of Gooley et al to estimate the cumulative incidence of relapse.
Time frame: From the date of transplantation, assessed up to 1 year after transplantation.
Overall survival
The method of Kaplan and Meier will be used to estimate the distribution of overall survival. Cox proportional hazards regression analysis will be used to model the association between overall survival and covariates of interest.
Time frame: From the date of transplantation, assessed up to 1 year after transplantation.
Incidence of toxicity of the regimen
Descriptive statistics will be used to summarize adverse events.
Time frame: From the date of transplantation, assessed up to 1 year after transplantation.
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