A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Registration Number
- NCT06389292
- Lead Sponsor
- Ascentage Pharma Group Inc.
- Brief 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.
- Detailed Description
The newly diagnosed acute myeloid leukemia, who are not eligible for standard induction chemotherapy, will be randomized to the investigational group (Lisaftoclax+ AZA) or the control group (placebo+ AZA).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 486
- Patients must have newly diagnosed AML that meets the criteria for acute myeloid leukemia (AML) and be 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.
- The patient was diagnosed with acute promyelocytic leukemia or AML (BCR-ABL1 positive.
- Active leukemic infiltration of the central nervous system.
- Active infection that requires systemic treatment.
- Use of a moderate or strong inducer and/or inhibitor of CYP3A4 within 7 days prior to first dose of the study 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 the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lisaftoclax (APG-2575) combined with Azacitidine Lisaftoclax (APG-2575) - Lisaftoclax (APG-2575) combined with Azacitidine Azacitidine Injection - Placebo combined with Azacitidine Placebo - Placebo combined with Azacitidine Azacitidine Injection -
- Primary Outcome Measures
Name Time Method Overall Survival（OS） Up to 5 years The primary endpoint was overall survival (OS), defined as the time from the date of randomization to the date of death of any cause.
- Secondary Outcome Measures
Name Time Method Safety evaluation based on the adverse event concurrence Up to 5 years Number of treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs) will be evaluated.
Percentage of Participants with Objective Response Rate (ORR) Up to 5 years ORR is defined as the proportion of patients who have achieved CR, CRi, CRh, MLFS or PR.
Trial Locations
- Locations (2)
Hematology Hospital of the Chinese Academy of Medical Sciences
🇨🇳Tianjin, Tianjin, China
The First Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China