A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia

Launched by ASCENTAGE PHARMA GROUP INC. · Apr 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option for patients with acute myeloid leukemia (AML), a type of blood cancer. Specifically, the trial is looking at a medication called APG-2575 (also known as Lisaftoclax) when combined with another drug called azacitidine. The goal is to see if this combination works better than azacitidine alone for patients who are newly diagnosed with AML and cannot undergo standard chemotherapy due to their health conditions.

To participate in this study, patients need to be newly diagnosed with AML and must meet certain health criteria, such as being able to take medications by mouth and having a life expectancy of at least three months. They should also be between the ages of 18 and 74 and have good kidney and liver function. Participants will receive either the combination of APG-2575 and azacitidine or a placebo (a substance with no active medication) along with azacitidine. Throughout the trial, participants will have regular check-ups to monitor their health and the effectiveness of the treatment. This trial is currently recruiting participants, and it is important for those interested to discuss with their doctors to see if they qualify.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients must have newly diagnosed AML that meets the criteria for acute myeloid leukemia (AML) and ineligible for standard chemotherapy.
• • 2. Life expectancy of ≥3 months.
• • 3. Be able to accept oral administration.
• • 4. Patients aged ≥70 years with ECOG score of 0-2, or those aged≥18 years and \<70 years with ECOG score of 0-3.
• • 5. Adequate kidney function.
• • 6. White blood cell ≤ 30×10\^9/L.
• • 7. Adequate liver function.
• • 8. Men, women with childbearing potential, and their partners voluntarily use contraception that researchers consider effective.
• • 9. Be able to understand and voluntarily sign written informed consent.
• • 10. Patients must be willing and able to complete study procedures and follow-up examinations.
• Exclusion Criteria:
• • 1. The patient was diagnosed with acute promyelocytic leukemia or AML BCR-ABL1 positive.
• • 2. Active leukemic infiltration of the central nervous system.
• • 3. Active infection that requires systemic treatment.
• • 4. Use of a moderate or strong inducer and/or inhibitor of CYP3A4 within 7 days prior to first dose of the study drug.
• • 5. Previous treatment for hematologic disorders.
• • 6. Patients who has a cardiovascular disability status of New York Heart Association Class \> 2.
• • 7. Patients have malabsorption syndrome or other conditions that cannot be administered through the gastrointestinal tract or affect drug absorption.
• • 8. Patients had a history of other malignancies prior to study initiation.
• • 9. Any other circumstances or conditions, at the discretion of the investigator, make the patient unsuitable to participate in the study.