Actively Recruiting
A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia
Led by Ascentage Pharma Group Inc. · Updated on 2025-11-25
486
Participants Needed
6
Research Sites
249 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed acute myeloid leukemia patients ineligible for standard chemotherapy
- Life expectancy of at least 3 months
- Able to take medication by mouth
- Age 70 years or older with ECOG score 0-2, or age 18 to under 70 years with ECOG score 0-3
- Adequate kidney function
- White blood cell count less than or equal to 30 x 10^9/L
- Adequate liver function
- Men, women with childbearing potential, and their partners agree to use effective contraception
- Able to understand and voluntarily sign informed consent
- Willing and able to complete study procedures and follow-up visits
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia or AML BCR-ABL1 positive
- Active leukemia affecting the central nervous system
- Uncontrolled infection requiring systemic treatment
- Use of strong CYP3A4 inducers within 7 days before first study drug dose or moderate to strong CYP3A4 inhibitors within 7 days or 3-5 half-lives before first dose
- Previous treatment for blood disorders
- New York Heart Association Class greater than 2 cardiovascular disability
- Malabsorption syndrome or conditions affecting drug absorption through the digestive tract
- History of other cancers before study start
- Any other condition that makes participation unsafe or unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Hematology Hospital of the Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
2
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
3
Moscow Multidisciplinary Clinical Center "Kommunarka"
Moscow, Russia, 108814
Actively Recruiting
4
Botkin Moscow Multidisciplinary Research and Clinical Center
Moscow, Russia, 125284
Actively Recruiting
5
Russian Research Institute of Hematology and Transfusiology of the Federal Medical and Biological Agency
Saint Petersburg, Russia, 191024
Actively Recruiting
6
Leningrad Regional Clinical Hospital
Saint Petersburg, Russia, 194291
Actively Recruiting
Research Team
Y
Yifan Zhai, M.D., Ph.D.
CONTACT
L
Lihui Liu, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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