Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT06389292

Recruiting

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

Interventional

Phase 3

The First Affiliated Hospital of Zhejiang University School of Medicine

Sponsor: Ascentage Pharma

Last Updated: November 25, 2025
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

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.

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Treatment Category

Other, Targeted Therapy, Other Drugs

Required Mutations

None

Trial Started

June 11, 2024

Last Updated by Sponsor

November 25, 2025

Estimated Completion

May 25, 2028

Contact Study

Name:Yifan Zhai, M.D., Ph.D.

Email:yzhai@ascentage.com

Phone:+86-20-28068501

Name:Lihui Liu, M.D.

Email:Lihui.Liu@ascentage.com

Eligibility

Inclusion Criteria

1. Patients must have newly diagnosed AML that meets the criteria for acute myeloid leukemia (AML) and ineligible for standard chemotherapy.

2. Life expectancy of ≥3 months.

3. Be able to accept oral administration.

4. Patients aged ≥70 years with ECOG score of 0-2, or those aged≥18 years and <70 years with ECOG score of 0-3.

5. Adequate kidney function.

6. White blood cell ≤ 30×10^9/L.

7. Adequate liver function.

8. Men, women with childbearing potential, and their partners voluntarily use contraception that researchers consider effective.

9. Be able to understand and voluntarily sign written informed consent.

10. Patients must be willing and able to complete study procedures and follow-up examinations.

Exclusion Criteria

1. The patient was diagnosed with acute promyelocytic leukemia or AML BCR-ABL1 positive.

2. Active leukemic infiltration of the central nervous system.

3. Active infection that is uncontrolled and requires systemic treatment.

4. Use of strong inducers of CYP3A4 within 7 days prior to the first dose of the investigational drug, and/or use of moderate to strong inhibitors of CYP3A4 within 7 days or 3-5 half-lives (whichever is longer) prior to the first dose of the investigational drug.

5. Previous treatment for hematologic disorders.

6. Patients who has a cardiovascular disability status of New York Heart Association Class > 2.

7. Patients have malabsorption syndrome or other conditions that cannot be administered through the gastrointestinal tract or affect drug absorption.

8. Patients had a history of other malignancies prior to study initiation.

9. Any other circumstances or conditions, at the discretion of the investigator, make the patient unsuitable to participate in the study.

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Design Details

AllocationRandomized

Intervention ModelParallel Assignment

MaskingDouble

Number to Enroll486

Arms & Interventions

Arms

Interventions

Type: Active Comparator

Description:

Interventions:

Placebo
APG-2575(Lisaftoclax )
Azacitidine Injection

Outcome Measures

Primary Outcome Measures

Overall Survival（OS）Up to 5 years

The primary endpoint was overall survival (OS), defined as the time from the date of randomization to the date of death of any cause.

Secondary Outcome Measures

Percentage of Participants with Objective Response Rate (ORR)Up to 5 years

ORR is defined as the proportion of patients who have achieved CR, CRi, CRh, MLFS or PR.

Safety evaluation based on the adverse event concurrenceUp to 5 years

Number of treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs) will be evaluated.

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Trial Sites

This study has 6 trial sites

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, CN

Recruiting

Hangzhou, Zhejiang, 310003 CN

The First Affiliated Hospital of Zhejiang University School of Medicine

Recruiting

Saint Petersburg, 194291 RU

Leningrad Regional Clinical Hospital

Recruiting

Tianjin, Tianjin Municipality, 300020 CN

Hematology Hospital of the Chinese Academy of Medical Sciences

Recruiting

Moscow, 108814 RU

Moscow Multidisciplinary Clinical Center "Kommunarka"

Recruiting

Moscow, 125284 RU

Botkin Moscow Multidisciplinary Research and Clinical Center

Recruiting

Saint Petersburg, 191024 RU

Russian Research Institute of Hematology and Transfusiology of the Federal Medical and Biological Agency

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