A global multicenter, randomized, double-blind, placebo-controlled, pivotal phase III study. To evaluate overall survival (OS) of Lisaftoclax (APG-2575) combined with azacitidine (AZA) vs. placebo combined with azacitidine in newly diagnosed patients with HR-MDS.
This study intends to enroll patients with HR-MDS to receive the therapy of Lisaftoclax (APG-2575) combined with azacitidine (AZA) or placebo combined with azacitidine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
490
QD, oral administration.
QD, hypodermic or intravenous injection.
QD, oral administration.
MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGPeking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGOverall Survival(OS)
The primary endpoint was overall survival (OS), defined as the time from the date of randomization to the date of death of any cause.
Time frame: Up to 5 years
Safety evaluation based on the adverse event concurrence
Number of treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs) will be evaluated.
Time frame: Up to 5 years
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