Status:
RECRUITING
Study of Lisaftoclax (APG-2575) Single Agent and Combination With Therapy in Patients Relapsed/Refractory AML
Lead Sponsor:
Ascentage Pharma Group Inc.
Collaborating Sponsors:
Suzhou Yasheng Pharmaceutical Co., Ltd.
Conditions:
Relapsed/Refractory Acute Myeloid Leukaemia
Myeloid Malignancy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 m...
Detailed Description
This is an open-label, multi-center Phase Ib study of safety, PK of Lisaftoclax (APG-2575) as single agent or in combination with HHT or AZA in relapsed/refractory AML and related myeloid malignancies...
Eligibility Criteria
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
- 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.
- 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).
- Known leukemia infiltration of the central nervous system.
- Symptomatic active fungal, bacterial and/or viral infections.
- 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.
- 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.
Key Trial Info
Start Date :
September 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
458 Patients enrolled
Trial Details
Trial ID
NCT04501120
Start Date
September 28 2020
End Date
September 1 2029
Last Update
September 26 2025
Active Locations (12)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
2
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
3
Sun Yat-sen University Cancer Center
Guangzhou, Guandong, China
4
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080