NCT04501120 Study of Lisaftoclax (APG-2575) Single Agent and Combination With Therapy in Patients Relapsed/Refractory AML
| NCT ID | NCT04501120 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Ascentage Pharma Group Inc. |
| Condition | Relapsed/Refractory Acute Myeloid Leukaemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 682 participants |
| Start Date | 2020-09-28 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 682 participants in total. It began in 2020-09-28 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 myeloid malignancies.
Eligibility Criteria
Inclusion Criteria: Subjects who meet each of the following inclusion criteria are eligible to participate in this study: 1. 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. 2. 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). 3. Subjects can accept oral administration of Lisaftoclax (APG-2575). 4. Life expectancy ≥ 3 months. 5. Adequate renal and liver function. 6. 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. 7. 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). 8. Willingness and ability to comply with study procedures and follow-up examination. Exclusion Criteria: Patients who meet any of the following exclusion criteria are not to be enrolled in this study: 1. Patients diagnosed with acute promyelocytic leukemia or t(9;22)(q34.1;q11.2); BCR-ABL1 positive AML patients. 2. 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). 3. Known leukemia infiltration of the central nervous system. 4. Symptomatic active fungal, bacterial and/or viral infections. 5. Prior history of allogeneic hematopoietic stem cell transplantation or adoptive cell immunotherapy, autologous hematopoietic stem cell transplantation within 12 months. 6. 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. 7. Within 7 days before the first dose of study drug, received a strong and/or moderate CYP3A inducer and/or Inhibitor. 8. At the discretion of the investigator, gastrointestinal diseases that affect the absorption of Lisaftoclax (APG-2575). 9. Any other condition or circumstance, at the discretion of the investigator, that patients would be unsuitable for participation in the study.
Contact & Investigator
Yifan Zhai, M.D., Ph.D.
STUDY DIRECTOR
Suzhou Yasheng Pharmaceutical Co., Ltd.
Frequently Asked Questions
Who can join the NCT04501120 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Relapsed/Refractory Acute Myeloid Leukaemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04501120 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04501120 currently recruiting?
Yes, NCT04501120 is actively recruiting participants. Contact the research team at jiej0503@163.com for enrollment information.
Where is the NCT04501120 trial being conducted?
This trial is being conducted at Beijing, China, Chongqing, China, Guangzhou, China, Guangzhou, China and 8 additional locations.
Who is sponsoring the NCT04501120 clinical trial?
NCT04501120 is sponsored by Ascentage Pharma Group Inc.. The principal investigator is Yifan Zhai, M.D., Ph.D. at Suzhou Yasheng Pharmaceutical Co., Ltd.. The trial plans to enroll 682 participants.