RecruitingPhase 3NCT06389292

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

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)


Sponsor

Ascentage Pharma Group Inc.

Enrollment

486 participants

Start Date

Jun 11, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of lisaftoclax (APG-2575), a new drug that helps cancer cells die, plus azacitidine (a standard drug for blood cancers) in older or less healthy adults with newly diagnosed acute myeloid leukemia (AML) who are not fit for intensive chemotherapy. **You may be eligible if...** - You are 70 or older with ECOG score 0–2, or between 18 and 70 with ECOG score 0–3 and unfit for standard chemotherapy - You have a new diagnosis of AML and have not received prior treatment for blood disorders - You have adequate kidney and liver function - You are able to take oral medications **You may NOT be eligible if...** - You have a special subtype of AML called acute promyelocytic leukemia (APL) or BCR-ABL1-positive AML - Your leukemia has spread to your brain and spinal fluid - You have an active uncontrolled infection - You have significant heart failure (New York Heart Association Class 3 or higher) - Your white blood cell count is above 30 billion cells per liter Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAPG-2575(Lisaftoclax )

QD, oral administration, every 28 days for a dosing cycle.

OTHERPlacebo

QD, oral administration, every 28 days for a dosing cycle.

DRUGAzacitidine Injection

QD, subcutaneous or intravenous injection, D1-7 in 28-day cycle.


Locations(6)

Hematology Hospital of the Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Moscow Multidisciplinary Clinical Center "Kommunarka"

Moscow, Russia

Botkin Moscow Multidisciplinary Research and Clinical Center

Moscow, Russia

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

Saint Petersburg, Russia

Leningrad Regional Clinical Hospital

Saint Petersburg, Russia

View Full Details on ClinicalTrials.gov

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NCT06389292


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