Tests lisaftoclax with azacitidine for newly diagnosed acute myeloid leukemia
Tests lisaftoclax with azacitidine against placebo in adults with newly diagnosed leukemia.
Plain-language title generated from the registry record
Registry title: A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia
Key facts
- Where
- Hangzhou and Tianjin, ChinaSee the 2 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed acute myeloid leukemia (AML) who cannot have standard chemotherapy. It tests lisaftoclax or placebo, each with azacitidine.
- Age
- 18 years or older. People 70 or older need an ECOG score of 0-2. People 18 to under 70 need an ECOG score of 0-3.
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed AML, not able to have standard chemotherapy. White blood cell count of 30×10^9/L or lower. Life expectancy of 3 months or more.
- Earlier treatment
- No previous treatment for blood disorders.
Main reasons for not taking part
- Acute promyelocytic leukemia or BCR-ABL1 positive AML
- Leukemia active in the central nervous system
- Uncontrolled infection that needs treatment through the body
- Another cancer before the trial started
- Heart disease worse than New York Heart Association Class 2
Read by machine on 12 November 2026.
Where in China
- The First Affiliated Hospital of Zhejiang University School of MedicineHangzhou, ChinaContact: Jie Jin, M.D.Taking people
- Hematology Hospital of the Chinese Academy of Medical SciencesTianjin, ChinaContact: Hui Wei, M.D.Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Ascentage Pharma Group Inc.
- Trial code
- NCT06389292EU 2024-516436-10-00
- Record updated
- 25 November 2025
- Original description
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.Read full original descriptionShow less
A Global, Multicenter, Randomized, Double-blind, Phase 3 Pivotal Registrational Clinical Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (GLORA-3)
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.
Inclusion: 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.
Exclusion: 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; Active infection that is uncontrolled and requires systemic treatment; 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; The patient was diagnosed with acute promyelocytic leukemia or AML BCR-ABL1 positive; Active leukemic infiltration of the central nervous system.