Study of Lisaftoclax (APG-2575) Single Agent and Combination With Therapy in Patients Relapsed/Refractory AML
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAscentage Pharma Group Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Lisaftoclax (APG-2575)
- Reduced-dose HHT
- standard-dose HHT
- Azacitidine
- Lisaftoclax (APG-2575)
- olverembatinib
Treatment groups
682 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Ascentage Pharma Group Inc.
Lead sponsor
Suzhou Yasheng Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov