A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia
A Global, Multicenter, Randomized, Double-blind, Phase 3 Pivotal Registrational Clinical Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (GLORA-3)
Ascentage Pharma Group Inc.
486 participants
Jun 11, 2024
INTERVENTIONAL
Conditions
Summary
A global, multicenter, randomized, double-blind, placebo-controlled, phase III pivotal registration study, to evaluate the efficacy of APG-2575 (Lisaftoclax) combined with azacitidine (AZA) versus placebo combined with azacitidine in newly diagnosed acute myeloid leukemia who are not eligible for standard induction chemotherapy.
Eligibility
Inclusion Criteria10
- Patients must have newly diagnosed AML that meets the criteria for acute myeloid leukemia (AML) and ineligible for standard chemotherapy.
- Life expectancy of ≥3 months.
- Be able to accept oral administration.
- Patients aged ≥70 years with ECOG score of 0-2, or those aged≥18 years and \<70 years with ECOG score of 0-3.
- Adequate kidney function.
- White blood cell ≤ 30×10\^9/L.
- Adequate liver function.
- Men, women with childbearing potential, and their partners voluntarily use contraception that researchers consider effective.
- Be able to understand and voluntarily sign written informed consent.
- Patients must be willing and able to complete study procedures and follow-up examinations.
Exclusion Criteria9
- The patient was diagnosed with acute promyelocytic leukemia or AML BCR-ABL1 positive.
- Active leukemic infiltration of the central nervous system.
- Active infection that is uncontrolled and requires systemic treatment.
- Use of strong inducers of CYP3A4 within 7 days prior to the first dose of the investigational drug, and/or use of moderate to strong inhibitors of CYP3A4 within 7 days or 3-5 half-lives (whichever is longer) prior to the first dose of the investigational drug.
- Previous treatment for hematologic disorders.
- Patients who has a cardiovascular disability status of New York Heart Association Class \> 2.
- Patients have malabsorption syndrome or other conditions that cannot be administered through the gastrointestinal tract or affect drug absorption.
- Patients had a history of other malignancies prior to study initiation.
- Any other circumstances or conditions, at the discretion of the investigator, make the patient unsuitable to participate in the study.
Interventions
QD, oral administration, every 28 days for a dosing cycle.
QD, oral administration, every 28 days for a dosing cycle.
QD, subcutaneous or intravenous injection, D1-7 in 28-day cycle.
Locations(6)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06389292