Study of APG2575 Single Agent and Combination With Therapy in Patients Relapsed/Refractory AML

Launched by ASCENTAGE PHARMA GROUP INC. · Aug 3, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called APG-2575 to see how safe it is and how well it works on its own or when combined with other treatments in patients with relapsed or refractory acute myeloid leukemia (AML) and similar blood cancers. The researchers want to find out how the body processes this medication and its effects on patients who have not responded to standard treatments. The trial is currently recruiting participants, and people aged 65 to 74 years may qualify if they meet certain health criteria.

To be eligible, participants must have a specific type of blood cancer that isn’t responding to treatment and can take medicine by mouth. They should also have a life expectancy of at least three months and be able to follow the study guidelines. Participants can expect to receive close medical monitoring during the trial. It's essential that they understand the study and agree to take part by signing a consent form. This trial could provide valuable information about new treatment options for patients who have limited choices due to their condition.

Gender

ALL

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 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 APG-2575.
• • 9. Any other condition or circumstance, at the discretion of the investigator, that patients would be unsuitable for participation in the study.