A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia
NCT ID: NCT06389292
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
486 participants
INTERVENTIONAL
2024-06-11
2029-03-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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APG-2575 (Lisaftoclax) combined with Azacitidine
APG-2575(Lisaftoclax )
QD, oral administration, every 28 days for a dosing cycle.
Azacitidine Injection
QD, subcutaneous or intravenous injection, D1-7 in 28-day cycle.
Placebo combined with Azacitidine
Placebo
QD, oral administration, every 28 days for a dosing cycle.
Azacitidine Injection
QD, subcutaneous or intravenous injection, D1-7 in 28-day cycle.
Interventions
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APG-2575(Lisaftoclax )
QD, oral administration, every 28 days for a dosing cycle.
Placebo
QD, oral administration, every 28 days for a dosing cycle.
Azacitidine Injection
QD, subcutaneous or intravenous injection, D1-7 in 28-day cycle.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Ascentage Pharma Group Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jianxiang Wang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Hematology Hospital of the Chinese Academy of Medical Sciences
Jie Jin, M.D.
Role: PRINCIPAL_INVESTIGATOR
Zhejiang University
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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APG2575AG301
Identifier Type: -
Identifier Source: org_study_id
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