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Study of Lisaftoclax (APG-2575) Single Agent and Combination With Therapy in Patients Relapsed/Refractory AML
Sponsor: Ascentage Pharma Group Inc.
Summary
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.
Official title: A Phase Ib Study of the Safety, Pharmacokinetic of Lisaftoclax (APG-2575) Single Agent and in Combination With Homoharringtonine or Azacitidine in Patients With Relapsed/Refractory AML
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
458
Start Date
2020-09-28
Completion Date
2029-09
Last Updated
2025-09-26
Healthy Volunteers
No
Interventions
Lisaftoclax (APG-2575)
Lisaftoclax (APG-2575) orally once daily, every 28 days as a cycle.
Reduced-dose HHT
1mg IV QD on Days 1-14 (28-day cycle).
standard-dose HHT
2mg/m\^2 IV QD on Days 1-7 (28-day cycle).
Azacitidine
75 mg/m\^2 SC or Iv gtt QD on Days 1- 7 (28-day cycle).
Lisaftoclax (APG-2575)
Lisaftoclax (APG-2575) orally once daily for 14 days, every 28 days as a cycle.
olverembatinib
orally, with meals, QOD, every 28 days as a cycle.
Locations (12)
Peking University People's Hospital
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Sun Yat-sen University Cancer Center
Guangzhou, Guandong, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Henan Tumor Hospital
Zhengzhou, Henan, China
Union Hospital medical college Huazhong University of Science and Technology
Wuhan, Hubei, China
Zhongnan Hospital of Hunan university
Wuhan, Hubei, China
Xiangya Hospital Central South University
Changsha, Hunan, China
The First affiliated hospital of Soochow University
Suzhou, Jiangsu, China
Shanghai The Sixth People' s Hospital
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
the First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China