Clinical Trial

A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia

Recruiting Phase 3
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Summary
A global, multicenter, randomized, double-blind, placebo-controlled, phase III pivotal registration study, to evaluate the efficacy of APG-2575 (Lisaftoclax) combined with azacitidine (AZA) versus placebo combined with azacitidine in newly diagnosed acute myeloid leukemia who are not eligible for standard induction chemotherapy.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-04-26; most recent amendment 2025-11-20.
Status change: Not Yet Recruiting → Recruiting 2024-07-22
Trial Details
NCT Number NCT06389292
Lead Sponsor Ascentage Pharma Group Inc.
Conditions Acute Myeloid Leukemia
Enrollment 486 participants
Start Date 2024-06-11
Primary Completion 2028-05-25 (estimated)
Study Completion 2029-03-26 (estimated)
Updated on ClinicalTrials.gov 2025-11-25