To explore the safety and efficacy of selinexor combined with azacitidine as post-transplant maintenance therapy for TP53-mutated AML/MDS.
This study focuses on AML/MDS patients with TP53 mutations who are at high risk of relapse. Following allogeneic hematopoietic stem cell transplantation, low-dose azacitidine combined with selinexor is administered as maintenance therapy. The objective is to evaluate the safety and tolerability of the combination of azacitidine and selinexor as post-transplant maintenance treatment. The primary endpoints are post-transplant relapse rate and non-relapse mortality. The secondary endpoints are overall survival and non-relapse mortality. Previous studies have reported that azacitidine and selinexor are safe and effective as post-transplant maintenance therapy for AML/MDS. In this study, the two-drug combination is administered post-transplant with the aim of reducing the risk of relapse and prolonging disease-free survival.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
azacitidine 35mg/m2
selinexor 20mg q2w
Chinese PLA General Hospital
Beijing, China
relapse free survival
Relapse free survival (RFS) refers to the time from treatment to the first disease progression or death of the patient for any reason.
Time frame: 1 year
overall survival (OS)
Overall survival (OS) refers to the time from the start of treatment to the death of the patient for any reason.
Time frame: 1 year
event free survival (EFS)
Event Free Survival (EFS) is a commonly used endpoint indicator in clinical trials to evaluate the survival time of patients without any adverse events during a specific time period. These adverse events include but are not limited to disease progression, death, treatment plan changes, and the occurrence of serious side effects
Time frame: 1 year
Cumulative Incidence of Relapse, CIR
Cumulative incidence of relapse (CIR) is the estimated probability of disease recurrence over time, calculated using a competing-risk model that accounts for non-relapse mortality as a competing event rather than censoring it.
Time frame: 1 year
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