Tests lisaftoclax with azacitidine for newly diagnosed acute myeloid leukemia
Tests lisaftoclax with azacitidine against placebo in adults with newly diagnosed leukemia.
Plain-language title generated from the registry record
Registry title: A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia
Key facts
- Where
- Lecce, Meldola, Pisa, Rome, Rozzano, and Turin, ItalySee the 6 sites
- Phase
- Phase 3
Where in Italy
- Ospedale Vito Fazzi LecceLecce, ItalyTaking people
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.lMeldola, ItalyTaking people
- Azienda Ospedaliero Universitaria PisanaPisa, ItalyTaking people
- Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, ItalyTaking people
- Humanitas Mirasole S.p.A.Rozzano, ItalyTaking people
- Azienda Ospedaliera Ordine Mauriziano di TorinoTurin, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ascentage Pharma Group Inc.
- Trial code
- NCT06389292EU 2024-516436-10-00
- Record updated
- 25 November 2025
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: 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; Active infection that is uncontrolled and requires systemic treatment; 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; The patient was diagnosed with acute promyelocytic leukemia or AML BCR-ABL1 positive; Active leukemic infiltration of the central nervous system.