Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

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

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 Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia (NCT06389292) is a Phase 3 interventional studying Acute Myeloid Leukemia, sponsored by Ascentage Pharma Group Inc.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Acute Myeloid Leukemia, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 486 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form. 10. Patients must be willing and able to complete study procedures and follow-up examinations. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

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.

Locations (6)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Hematology Hospital of the Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Moscow Multidisciplinary Clinical Center "Kommunarka"

Moscow, Russia

Botkin Moscow Multidisciplinary Research and Clinical Center

Moscow, Russia

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

Saint Petersburg, Russia

Leningrad Regional Clinical Hospital

Saint Petersburg, Russia

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06389292), the sponsor (Ascentage Pharma Group Inc.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06389292 clinical trial studying?

Who can participate in NCT06389292?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06389292?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06389292. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06389292. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.