Übersicht

Eignung

Details zum Design

Arme & Interventionen

Ergebnismessungen

Studienzentren

Quelle: NCT06389292

Rekrutiert

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

Interventionsstudie

Phase 3

The First Affiliated Hospital of Zhejiang University School of Medicine

Sponsor: Ascentage Pharma

Zuletzt aktualisiert: 25. November 2025
Hinweis - Die Informationen stammen aus öffentlichen Registern und spiegeln möglicherweise nicht die Echtzeitänderungen am lokalen Studienzentrum wider.

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.

Detaillierte Beschreibung anzeigen

Behandlungskategorie

Andere, Zielgerichtete Therapie, Andere Medikamente

Erforderliche Mutationen

Keine

Studie gestartet

11. Juni 2024

Zuletzt vom Sponsor aktualisiert

25. November 2025

Voraussichtlicher Abschluss

25. Mai 2028

Studienkontakt

Name:Yifan Zhai, M.D., Ph.D.

E-Mail:yzhai@ascentage.com

Telefon:+86-20-28068501

Name:Lihui Liu, M.D.

E-Mail:Lihui.Liu@ascentage.com

Eignung

Einschlusskriterien

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.

Ausschlusskriterien

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 is uncontrolled and requires systemic treatment.

4. 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.

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.

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Design-Details

ZuteilungRandomized

InterventionsmodellParallel Assignment

MaskierungDouble

Anzahl der Teilnehmer486

Arme & Interventionen

Arme

Interventionen

Typ: Active Comparator

Beschreibung:

Interventionen:

Placebo
APG-2575(Lisaftoclax )
Azacitidine Injection

Ergebnismessungen

Primäre Ergebnismessungen

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.

Sekundäre Ergebnismessungen

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.

Safety evaluation based on the adverse event concurrenceUp to 5 years

Number of treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs) will be evaluated.

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Studienzentren

Diese Studie hat 6 Studienzentren

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, CN

Rekrutierend

Hangzhou, Zhejiang, 310003 CN

The First Affiliated Hospital of Zhejiang University School of Medicine

Rekrutierend

Saint Petersburg, 194291 RU

Leningrad Regional Clinical Hospital

Rekrutierend

Tianjin, Tianjin Municipality, 300020 CN

Hematology Hospital of the Chinese Academy of Medical Sciences

Rekrutierend

Moscow, 108814 RU

Moscow Multidisciplinary Clinical Center "Kommunarka"

Rekrutierend

Moscow, 125284 RU

Botkin Moscow Multidisciplinary Research and Clinical Center

Rekrutierend

Saint Petersburg, 191024 RU

Russian Research Institute of Hematology and Transfusiology of the Federal Medical and Biological Agency

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