Combining APG-2575 with Azacitidine for treating Acute Myeloid Leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pivotal phase III study evaluates the efficacy of APG-2575 (Lisaftoclax) in combination with azacitidine compared to a placebo with azacitidine in patients with newly diagnosed acute myeloid leukemia (AML) who are not eligible for standard chemotherapy. Participants will be randomly assigned to receive either the investigational treatment or the control. The study aims to determine if this combination can improve outcomes for patients who have limited treatment options due to their condition.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hematology Hospital of the Chinese Academy of Medical Sciences
  Tianjin, Tianjin Municipality, China Recruiting
• The First Affiliated Hospital of Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting
• Moscow Multidisciplinary Clinical Center "Kommunarka"
  Moscow, Russia Recruiting
• Botkin Moscow Multidisciplinary Research and Clinical Center
  Moscow, Russia Recruiting
• Russian Research Institute of Hematology and Transfusiology of the Federal Medical and Biological Agency
  Saint Petersburg, Russia Recruiting
• Leningrad Regional Clinical Hospital
  Saint Petersburg, Russia Recruiting

Study contacts

• Principal investigator: Jianxiang Wang, M.D. — Hematology Hospital of the Chinese Academy of Medical Sciences
• Study coordinator: Yifan Zhai, M.D., Ph.D.
• Email: yzhai@ascentage.com
• Phone: +86-20-28068501

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.