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drugset / Trial / NCT06389292

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

NCT06389292 ↗

Phase 3 Recruiting 486 enrolled Ascentage Pharma Group Inc.
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2024-06-11
Primary completion
2028-05-25
Completion
2029-03-26

Drugs

EvaluationDrugModalityDoseRoute
Subject APG-2575 Small molecule — Oral
Background Azacitidine Other / unclassified — Subcutaneous

Indications

acute myeloid leukemia