Acute Myeloid LeukemiaPhase 3NCT06389292
A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia
A Phase 3 study testing APG-2575(Lisaftoclax ) and Azacitidine Injection in people with Acute Myeloid Leukemia, run by Ascentage Pharma Group Inc. at 6 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- APG-2575(Lisaftoclax ) and Azacitidine Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 486 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 11 Jun 2024to 26 Mar 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Lihui Liu, M.D. contact
6 sites in 2 countries
Russia4 sites, 4 recruiting
- Recruiting
Moscow Multidisciplinary Clinical Center "Kommunarka"
Moscow, 108814
Natalia CHERNOVA, Dr.Med.Sci, 7-916-660-27-63, 79166602763@mail.ru
Natalia CHERNOVA, Dr.Med.Sci
- Recruiting
Botkin Moscow Multidisciplinary Research and Clinical Center
Moscow, 125284
Vadim DORONIN, MD, 7-926-270-83-45, vadim_doronin@mail.ru
Vadim DORONIN, MD
- Recruiting
Russian Research Institute of Hematology and Transfusiology of the Federal Medical and Biological Agency
Saint Petersburg, 191024
Alexey KUVSHINOV, Ph.D., 7-921-370-88-46, xupypr83@mail.ru
Alexey KUVSHINOV, Ph.D.
- Recruiting
Leningrad Regional Clinical Hospital
Saint Petersburg, 194291
Sergey VOLOSHIN, Ph.D., 7-921-955-07-49, servolos@gmail.com
Sergey VOLOSHIN, Ph.D.
China2 sites, 2 recruiting
- Recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Jie Jin, M.D., jiej0503@163.com
0571-87236896
- Recruiting
Hematology Hospital of the Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020
Hui Wei, M.D., 022-23909120, weihui@ihcams.ac.cn
Hui Wei, M.D.
About this study
Official title: 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.
Read the detailed description
The newly diagnosed acute myeloid leukemia, who are not eligible for standard induction chemotherapy, will be randomized to the investigational group 'Lisaftoclax (APG-2575) + AZA' or the control group 'placebo+ AZA'.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- APG-2575(Lisaftoclax ), Placebo, Azacitidine Injection
- Keywords
- APG -2575, Lisaftoclax
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APG-2575(Lisaftoclax )Drug
QD, oral administration, every 28 days for a dosing cycle.
PlaceboOther
QD, oral administration, every 28 days for a dosing cycle.
Azacitidine InjectionDrug
QD, subcutaneous or intravenous injection, D1-7 in 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| APG-2575 (Lisaftoclax) combined with Azacitidine | Experimental | Not described Receives: Drug: APG-2575(Lisaftoclax ); Drug: Azacitidine Injection |
| Placebo combined with Azacitidine | Active comparator | Not described Receives: Other: Placebo; Drug: Azacitidine Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 years
Secondary outcomes (2)
Percentage of Participants with Objective Response Rate (ORR)
ORR is defined as the proportion of patients who have achieved CR, CRi, CRh, MLFS or PR.
Measured: Up to 5 years
Safety evaluation based on the adverse event concurrence
Number of treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs) will be evaluated.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start11 Jun 2024
- Primary completion25 May 2028 (estimated)
- Study completion26 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Ascentage Pharma Group Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 486 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ascentage Pharma Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianxiang Wang, M.D., Principal investigator, Hematology Hospital of the Chinese Academy of Medical SciencesJie Jin, M.D., Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389292
- Sponsor's protocol ID
- APG2575AG301
- Status last verified
- Nov 2025
- First submitted
- 24 Apr 2024
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06389292
- Acronym / sponsor ID
- APG2575AG301
- Conditions
- Acute Myeloid Leukemia
- Keywords
- APG -2575, Lisaftoclax
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 486 participants (estimated)
- Lead sponsor
- Ascentage Pharma Group Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- 25 May 2028 (estimated)
- Study completion
- 26 Mar 2029 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The newly diagnosed acute myeloid leukemia, who are not eligible for standard induction chemotherapy, will be randomized to the investigational group 'Lisaftoclax (APG-2575) + AZA' or the control group 'placebo+ AZA'.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APG-2575(Lisaftoclax )QD, oral administration, every 28 days for a dosing cycle. | Drug | APG-2575 (Lisaftoclax) combined with Azacitidine |
| PlaceboQD, oral administration, every 28 days for a dosing cycle. | Other | Placebo combined with Azacitidine |
| Azacitidine InjectionQD, subcutaneous or intravenous injection, D1-7 in 28-day cycle. | Drug | APG-2575 (Lisaftoclax) combined with Azacitidine, Placebo combined with Azacitidine |
Primary outcome
Overall Survival（OS）
Time frame: 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.
2 secondary outcomes
Percentage of Participants with Objective Response Rate (ORR)
Time frame: Up to 5 years
Safety evaluation based on the adverse event concurrence
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lihui Liu, M.D. contact
Jianxiang Wang, M.D. principal investigator
Hematology Hospital of the Chinese Academy of Medical Sciences
Jie Jin, M.D. principal investigator
First Affiliated Hospital of Zhejiang University
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing APG-2575(Lisaftoclax ) and Azacitidine Injection in people with Acute Myeloid Leukemia, run by Ascentage Pharma Group Inc. at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Russia, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yifan Zhai, M.D., Ph.D. (+86-20-28068501, yzhai@ascentage.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival（OS） (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.