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

Официальное название

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)

Обзор

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.

Подробное описание

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'.

Вмешательства

• Препарат APG-2575(Lisaftoclax )
  QD, oral administration, every 28 days for a dosing cycle.
• Другое Placebo
  QD, oral administration, every 28 days for a dosing cycle.
• Препарат Azacitidine Injection
  QD, subcutaneous or intravenous injection, D1-7 in 28-day cycle.

Первичные конечные точки

• Overall Survival（OS） [Срок оценки: Up to 5 years]

Вторичные конечные точки (2)

• Percentage of Participants with Objective Response Rate (ORR) [Срок оценки: Up to 5 years]
• Safety evaluation based on the adverse event concurrence [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Россия · 4 центра

• 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

Китай · 2 центра

• Hematology Hospital of the Chinese Academy of Medical Sciences — Тяньцзинь
• The First Affiliated Hospital of Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT06389292 · APG2575AG301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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