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

NCT06389292 | Recruiting Phase 3 DMC

• 1 other identifier: APG2575AG301
• Study Type: interventional
• Target: 486
• Locations: 2 countries
• Sites: 6

Brief 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

Acute Myeloid Leukemia

Keywords

APG -2575; Lisaftoclax

Outcome Measures

Primary Outcomes (1)

• Overall 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.

  Up to 5 years

Secondary Outcomes (2)

• Percentage of Participants with Objective Response Rate (ORR)

  Up to 5 years

• Safety evaluation based on the adverse event concurrence

  Up to 5 years

Study Arms (2)

APG-2575 (Lisaftoclax) combined with Azacitidine

EXPERIMENTAL

Drug: APG-2575(Lisaftoclax ); Drug: Azacitidine Injection

Placebo combined with Azacitidine

ACTIVE COMPARATOR

Other: Placebo; Drug: Azacitidine Injection

Interventions

APG-2575(Lisaftoclax ) DRUG

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

APG-2575 (Lisaftoclax) combined with Azacitidine

Placebo OTHER

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

Placebo combined with Azacitidine

Azacitidine Injection DRUG

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

APG-2575 (Lisaftoclax) combined with Azacitidine; Placebo combined with Azacitidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have newly diagnosed AML that meets the criteria for acute myeloid leukemia (AML) and ineligible for standard chemotherapy.
• Life expectancy of ≥3 months.
• Be able to accept oral administration.
• Patients aged ≥70 years with ECOG score of 0-2, or those aged≥18 years and \<70 years with ECOG score of 0-3.
• Adequate kidney function.
• White blood cell ≤ 30×10\^9/L.
• Adequate liver function.
• Men, women with childbearing potential, and their partners voluntarily use contraception that researchers consider effective.
• Be able to understand and voluntarily sign written informed consent.
• Patients must be willing and able to complete study procedures and follow-up examinations.

You may not qualify if:

• The patient was diagnosed with acute promyelocytic leukemia or AML BCR-ABL1 positive.
• Active leukemic infiltration of the central nervous system.
• Active infection that is uncontrolled and requires systemic treatment.
• 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.
• Previous treatment for hematologic disorders.
• Patients who has a cardiovascular disability status of New York Heart Association Class \> 2.
• Patients have malabsorption syndrome or other conditions that cannot be administered through the gastrointestinal tract or affect drug absorption.
• Patients had a history of other malignancies prior to study initiation.
• Any other circumstances or conditions, at the discretion of the investigator, make the patient unsuitable to participate in the study.

Sponsors & Collaborators

• Ascentage Pharma Group Inc.: lead

Study Sites (6)

Hematology Hospital of the Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

Moscow Multidisciplinary Clinical Center "Kommunarka"

Moscow, 108814, Russia

RECRUITING

Botkin Moscow Multidisciplinary Research and Clinical Center

Moscow, 125284, Russia

RECRUITING

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

Saint Petersburg, 191024, Russia

RECRUITING

Leningrad Regional Clinical Hospital

Saint Petersburg, 194291, Russia

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Lisaftoclax; Azacitidine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Jianxiang Wang, M.D.

  Hematology Hospital of the Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Jie Jin, M.D.

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yifan Zhai, M.D., Ph.D.

CONTACT

+86-20-28068501; yzhai@ascentage.com

Lihui Liu, M.D.

CONTACT

Lihui.Liu@ascentage.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: April 29, 2024
• Study Start: June 11, 2024
• Primary Completion (Estimated): May 25, 2028
• Study Completion (Estimated): March 26, 2029
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

RU (4); CN (2)