A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: APG-2575(Lisaftoclax ), Placebo, Azacitidine Injection.
- Who it may be relevant to
- Registry conditions: Acute Myeloid Leukemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China, Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
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 (APG-2575) + AZA' or the control group 'placebo+ AZA'.
Interventions
- Drug APG-2575(Lisaftoclax )
QD, oral administration, every 28 days for a dosing cycle. - Other Placebo
QD, oral administration, every 28 days for a dosing cycle. - Drug Azacitidine Injection
QD, subcutaneous or intravenous injection, D1-7 in 28-day cycle.
Primary outcome measures
- Overall Survival（OS） [Time frame: Up to 5 years]
Secondary outcome measures (2)
- Percentage of Participants with Objective Response Rate (ORR) [Time frame: Up to 5 years]
- Safety evaluation based on the adverse event concurrence [Time frame: Up to 5 years]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Russia · 4 centers
- Moscow Multidisciplinary Clinical Center "Kommunarka" — Moscow
- Botkin Moscow Multidisciplinary Research and Clinical Center — Moscow
- Russian Research Institute of Hematology and Transfusiology of the Federal Medical and Bio — Saint Petersburg
- Leningrad Regional Clinical Hospital — Saint Petersburg
China · 2 centers
- Hematology Hospital of the Chinese Academy of Medical Sciences — Tianjin
- The First Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou
Identifiers
NCT: NCT06389292 · APG2575AG301