MedTrace Logo

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

NCT06389292 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 486

Last updated 2025-11-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

APG-2575(Lisaftoclax )

QD, oral administration, every 28 days for a dosing cycle.

OTHER

Placebo

QD, oral administration, every 28 days for a dosing cycle.

DRUG

Azacitidine Injection

QD, subcutaneous or intravenous injection, D1-7 in 28-day cycle.

Sponsors & Collaborators

  • Ascentage Pharma Group Inc.

    lead INDUSTRY

Principal Investigators

  • Jianxiang Wang, M.D. · Hematology Hospital of the Chinese Academy of Medical Sciences

  • Jie Jin, M.D. · Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China
  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06389292 on ClinicalTrials.gov