Actively Recruiting
Study of Lisaftoclax (APG-2575) Single Agent and Combination With Therapy in Patients Relapsed/Refractory AML
Led by Ascentage Pharma Group Inc. · Updated on 2026-04-29
682
Participants Needed
12
Research Sites
465 weeks
Total Duration
On this page
Sponsors
A
Ascentage Pharma Group Inc.
Lead Sponsor
S
Suzhou Yasheng Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to assess the safety, pharmacokinetic profile of Lisaftoclax (APG-2575) single agent and in combination with HHT/AZA in patients with relapsed/refractory AML and related myeloid malignancies.
CONDITIONS
Official Title
Study of Lisaftoclax (APG-2575) Single Agent and Combination With Therapy in Patients Relapsed/Refractory AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with relapsed or refractory AML, MPAL, CMML, HR-MDS, BPDCN, or naive AML ineligible for standard chemotherapy due to age or other health conditions
- ECOG Performance Status 0-2 (or 0-3 for ages 60-74 ineligible for standard chemotherapy)
- Able to take Lisaftoclax orally
- Life expectancy of at least 3 months
- Adequate kidney and liver function
- Agree to use effective contraception during and for 3 months after treatment if of childbearing potential
- Able to understand and sign informed consent
- Willing and able to follow study procedures and attend follow-up visits
You will not qualify if you...
- Diagnosed with acute promyelocytic leukemia or BCR-ABL1 positive AML
- Ongoing severe side effects from prior chemotherapy or radiotherapy (except hair loss)
- Leukemia affecting the central nervous system
- Active fungal, bacterial, or viral infections
- History of allogeneic stem cell transplant or adoptive cell immunotherapy, or autologous stem cell transplant within 12 months
- Received chemotherapy, radiotherapy, surgery, immunotherapy, targeted therapy, biological therapy, or investigational treatment within 14 days before study drug
- Received strong or moderate CYP3A inducers or inhibitors within 7 days before study drug
- Gastrointestinal conditions affecting absorption of Lisaftoclax
- Any other condition making 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: 12 locations
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
2
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Not Yet Recruiting
3
Sun Yat-sen University Cancer Center
Guangzhou, Guandong, China
Actively Recruiting
4
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Actively Recruiting
5
Henan Tumor Hospital
Zhengzhou, Henan, China
Actively Recruiting
6
Union Hospital medical college Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
7
Zhongnan Hospital of Hunan university
Wuhan, Hubei, China, 430071
Actively Recruiting
8
Xiangya Hospital Central South University
Changsha, Hunan, China
Actively Recruiting
9
The First affiliated hospital of Soochow University
Suzhou, Jiangsu, China
Actively Recruiting
10
Shanghai The Sixth People' s Hospital
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
11
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610044
Actively Recruiting
12
the First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
J
Jie Jin, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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