AuthorisedTherapeutic confirmatory (Phase III)Interventional

An international, 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)

This important study, called GLORA-3, is looking for a better way to treat acute myeloid leukemia (AML) in older patients who have recently been diagnosed. Researchers want to see if a new drug called Lisaftoclax, when given with a standard treatment named azacitidine, can help people live longer. The study is comparing this new combination to azacitidine alone. It's a 'double-blind' study, meaning neither the patient nor their doctor will know if they are receiving Lisaftoclax or a dummy pill, to ensure fair results. The hope is to find a more effective treatment that could improve the lives of those living with AML.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Ascentage Pharma Group Inc.

Enrolment target

Start

05 May 2025

Acute myeloid leukemia

What is this study about?

Acute myeloid leukemia (AML) is a type of cancer that starts in the blood-forming cells of the bone marrow. When someone is diagnosed, especially if they are older, doctors look for the best ways to manage their condition. This study is focused on improving treatment options for these patients.

The main goal of this research, named GLORA-3, is to carefully compare two treatment approaches. One group of patients will receive the standard treatment, azacitidine, along with a new drug called Lisaftoclax. Another group will receive azacitidine with a dummy pill. By comparing these two groups, doctors hope to understand if Lisaftoclax can help patients live longer and improve other important factors, such as how long they stay well after treatment.

This is a 'phase 3' study, which means it's a large, important step in testing new treatments before they might become widely available. Doctors will also be monitoring how well patients respond to treatment, how long any improvements last, and if there are any side effects. This detailed information will help determine if Lisaftoclax could be a valuable new option for people with AML.

Key takeaways

Tests a new drug (Lisaftoclax) with standard treatment (azacitidine) for AML.
Aims to improve how long older patients with new AML diagnosis live.
Patients receive either Lisaftoclax or a dummy pill, plus azacitidine.
This is a large, important 'phase 3' study.
Close medical monitoring throughout your participation.

Who may be eligible?

This study is looking for adults aged 18 years and older who have been recently diagnosed with acute myeloid leukemia (a specific type of blood cancer).

Doctors will explain all the specific medical requirements to ensure the study is safe and appropriate for everyone taking part. Both men and women can join the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you recently been diagnosed with acute myeloid leukemia?
Are you willing to discuss all your current medical conditions with the study team?
Are you able to attend regular study appointments?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive either the new drug (Lisaftoclax) or a dummy pill, alongside the standard treatment (azacitidine). Neither you nor your doctor will know which you are receiving. You'll have regular hospital visits, where doctors will give you your medication, carry out various tests, and ask about your health. These tests may include blood samples and possibly bone marrow assessments, all to see how the treatment is working and monitor for any side effects. The study will continue for a period, with follow-up appointments to track your health and how you're feeling over time. The exact number of visits and the total length of your participation will be explained in detail.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access a new treatment that isn't yet widely available, and you'll receive close medical attention. While the new drug Lisaftoclax shows promise, like all medications, it might not work for everyone, and there could be side effects. The study team will carefully monitor your health throughout. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy
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Unverified
Spain
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Unverified
Poland

Common questions

What is azacitidine?

Azacitidine is a standard medication often used to treat acute myeloid leukemia and similar blood disorders.

What is a 'dummy pill'?

A dummy pill (also called a placebo) looks exactly like the real medicine but contains no active drug. It helps researchers safely compare the effects of the new treatment.

What does 'double-blind' mean?

It means that neither you nor your study doctor will know whether you are receiving the new drug or the dummy pill. This helps ensure the study results are unbiased and fair.

What does 'overall survival' mean in the study?

It refers to the time from when you start the study until any cause of death. It's a key measure to see if the new treatment helps people live longer.

Will I still get my normal medical care while in the study?

Yes, you will continue to receive close medical care from the study team and your regular doctors.