Tests lisaftoclax alone and combined in relapsed acute myeloid leukemia
Tests lisaftoclax, alone or with other drugs, in adults with relapsed acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Study of Lisaftoclax (APG-2575) Single Agent and Combination With Therapy in Patients Relapsed/Refractory AML
Key facts
- Where
- Beijing, Changsha, Chengdu, Chongqing, Guangzhou, Hangzhou, Shanghai, Suzhou, Wuhan, and Zhengzhou, ChinaSee the 12 sites
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with acute myeloid leukaemia that came back or did not respond to treatment, or with related blood cancers. It tests lisaftoclax alone or with other drugs.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Relapsed or refractory AML, mixed phenotype acute leukaemia, chronic myelomonocytic leukaemia, higher-risk myelodysplastic syndrome, or blastic plasmacytoid dendritic cell neoplasm. Newly diagnosed AML can also join if standard chemotherapy is not possible because of age or other illnesses.
- Earlier treatment
- No chemotherapy, radiotherapy, surgery, immunotherapy, targeted therapy, biological therapy or investigational treatment in the 14 days before the first dose (hydroxyurea is allowed more than 24 hours before). No strong or moderate CYP3A inducer or inhibitor in the 7 days before the first dose.
Main reasons for not taking part
- Acute promyelocytic leukaemia, or BCR-ABL1 positive AML
- Leukaemia spread to the central nervous system
- Symptomatic active fungal, bacterial or viral infection
- Allogeneic stem cell transplant or adoptive cell immunotherapy in the past, or autologous stem cell transplant within 12 months
- Stomach or bowel disease that affects how the drug is absorbed
Read by machine on 12 November 2026.
Where in China
- Peking University People's HospitalBeijing, ChinaContact: Qiang Jiang, ProfessorTaking people
- Xiangya Hospital Central South UniversityChangsha, ChinaContact: Yajing Xu, MasterTaking people
- West China Hospital of Sichuan UniversityChengdu, ChinaContact: Xiao Shuai, M.D.Taking people
- Chongqing University Cancer HospitalChongqing, ChinaContact: Yi Gong, M.D.Not yet recruiting
- Guangdong Provincial People's HospitalGuangzhou, ChinaContact: Jianyu Wong, M.D.Taking people
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaContact: Yang Liang, ProfessorTaking people
- The First Affiliated Hospital, College of Medicine, Zhejiang UniversityHangzhou, ChinaContact: Jie Jin, M.D.Taking people
- Shanghai The Sixth People' s HospitalShanghai, ChinaContact: Chunkang Chang, ProfessorNot yet recruiting
- The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaContact: Suning Chen, M.D.Taking people
- Union Hospital medical college Huazhong University of Science and TechnologyWuhan, ChinaContact: Qiubo Li, ProfessorTaking people
- Zhongnan Hospital of Hunan universityWuhan, ChinaContact: Fuling Zhou, ProfessorTaking people
- Henan Tumor HospitalZhengzhou, ChinaContact: Xudong Wei, ProfessorTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Ascentage Pharma Group Inc.
- Trial code
- NCT04501120
- Record updated
- 29 April 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Subjects who meet each of the following inclusion criteria are eligible to participate in this study:; In accordance with the World Health Organization (WHO) 2016 diagnostic criteria for relapsed or refractory acute myeloid leukemia (AML), Mixed phenotype acute leukemia(MPAL), Chronic myelomonocytic leukemia (CMML), Higher-risk myelodysplastic syndrome (HR-MDS) , Blastic plasmacytoid dendritic cell neoplasm (BPDCN) and naïve AML ineligible for treatment with a standard chemotherapy due to age or comorbidities; Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -2 (0 to 3 for participants >= 60 to 74 years of age who are evaluated as ineligible for treatment with standard chemotherapy); Subjects can accept oral administration of Lisaftoclax (APG-2575); Life expectancy ≥ 3 months; Adequate renal and liver function; Males, female patients of childbearing potential (postmenopausal women who must have been menopausal for at least 12 months to be considered infertile) and their partners voluntarily take contraception which the investigator considers effective during treatment and at least three months after the last dose of study drug; Ability to understand and willingness to sign a written informed consent form (the consent form must be signed by the patient prior to any study-specific procedures); Willingness and ability to comply with study procedures and follow-up examination.
Exclusion: The persistent toxicities caused by previous chemotherapy or radiotherapy has not been restored to lower than grade 2 by CTCAE 5.0 (except for alopecia); Prior history of allogeneic hematopoietic stem cell transplantation or adoptive cell immunotherapy, autologous hematopoietic stem cell transplantation within 12 months; Within 14 days before the first dose of study drug, received chemotherapy (hydroxyurea is permitted more than 24 hours before the first dose of study drug), radiotherapy, surgery, immunotherapy, targeted therapy, biological therapy or any investigational treatment; Within 7 days before the first dose of study drug, received a strong and/or moderate CYP3A inducer and/or Inhibitor; Symptomatic active fungal, bacterial and/or viral infections; At the discretion of the investigator, gastrointestinal diseases that affect the absorption of Lisaftoclax (APG-2575); Any other condition or circumstance, at the discretion of the investigator, that patients would be unsuitable for participation in the study; Patients who meet any of the following exclusion criteria are not to be enrolled in this study:; Patients diagnosed with acute promyelocytic leukemia or t(9;22)(q34.1;q11.2); BCR-ABL1 positive AML patients; Known leukemia infiltration of the central nervous system.