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Study of Lisaftoclax combined with azacitidine for elderly patients with newly diagnosed acute myeloid leukemia

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with newly diagnosed Acute Myeloid Leukemia, a type of blood cancer that affects the bone marrow and blood cells. The research evaluates a combination treatment using two medications: Lisaftoclax (also known as APG-2575), which is taken as oral tablets, and azacitidine, which is given through injection under the skin or into a vein. The purpose is to determine if this combination treatment works better than using azacitidine with placebo in elderly patients or those who cannot receive standard chemotherapy.

The study uses Lisaftoclax, which belongs to a group of medications that work by blocking a protein called BCL-2 that helps cancer cells survive. Azacitidine is a medication that affects how genes work in cancer cells. Patients will receive either Lisaftoclax or placebo tablets along with azacitidine injections. The treatment continues for several months, with regular check-ups to monitor the patient's health and how well the treatment is working.

During the study, patients will take the medications according to a specific schedule. Lisaftoclax or matching placebo tablets are taken by mouth, while azacitidine is given as an injection either under the skin or into a vein. The maximum daily dose of Lisaftoclax is 600 milligrams, and azacitidine is given at 75 milligrams per square meter of body surface area.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
You will receive a combination of two medications: Lisaftoclax (oral tablets) and Azacitidine
The treatment will be divided into two groups - one group receives Lisaftoclax with Azacitidine, while the other receives a placebo (inactive tablet) with Azacitidine
Azacitidine will be administered either through an intravenous infusion (into a vein) or as a subcutaneous injection (under the skin)
Lisaftoclax is taken as oral tablets, with each tablet containing 200 mg of the medication
Step 2
Treatment monitoring
Your health status will be regularly monitored throughout the study
Regular blood tests will be conducted to check your white blood cell count and liver function
Your kidney function will be monitored through creatinine clearance tests
You will complete quality of life questionnaires (EORTC QLQ C30 and EQ-5D) during the study
Step 3
Treatment duration
The treatment will continue for at least 6 cycles
The study is planned to run from May 2025 to August 2029
Your participation may end earlier if your disease progresses or if you experience significant side effects
Follow-up examinations will continue for at least 6 months after your last dose of study medication
Step 4
Safety monitoring
Any side effects or unexpected health changes will be recorded and monitored
Your doctor will assess if any symptoms are related to the study treatment
Regular health assessments will evaluate how well you tolerate the medications

Who can join the trial?

12 criteria

Must be at least 18 years old
Must be able to understand and sign a voluntary consent form for the study
Must be willing to complete all study procedures and follow-up visits
Must be newly diagnosed with Acute Myeloid Leukemia (AML) and unable to receive standard chemotherapy due to age or other health conditions
Must have a life expectancy of at least 3 months
Must be able to take medications by mouth
If 70 years or older: must have an ECOG score (a measure of daily living abilities) of 0-2 If between 18-69 years: must have an ECOG score of 0-3
Must have adequate kidney function with creatinine clearance of at least 30 mL/min
Must have a white blood cell count no higher than 30 × 10⁹/L
Must have adequate liver function: - Liver enzymes (ALT and AST) no more than 2.5 times the normal limit - Total bilirubin no more than 1.5 times the normal limit (or 3 times for patients aged 18-69)
If able to have children, must agree to use effective birth control during treatment and for 6 months after the last dose
For patients aged 18-69, must have at least one of these conditions: - An ECOG score of 2-3 - Heart problems including heart failure or reduced heart function - Reduced lung function - Decreased kidney function - Elevated bilirubin levels - Other health conditions that prevent standard chemotherapy use

Who cannot join the trial?

13 criteria

Prior treatment with chemotherapy, targeted therapy, or investigational agents for Acute Myeloid Leukemia (AML)
Active or uncontrolled infections requiring systemic treatment
Significant heart conditions, including uncontrolled heart failure or unstable heart disease within the past 6 months
Severe kidney problems (requiring dialysis)
Severe liver disease
Known active central nervous system involvement from leukemia
Other types of cancer requiring treatment in the past 2 years (except for adequately treated skin cancer or early-stage cancer)
Psychiatric conditions that could interfere with study participation
Pregnancy or breastfeeding
Unable to swallow oral medications
Known allergic reactions to study medications
Life expectancy less than 3 months due to other medical conditions
Participation in another clinical trial within 30 days before starting this study

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Verified sites

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Azienda Ospedaliera Ordine Mauriziano Di Torino
Responsive
Turin, Italy
Azienda Ospedaliero Universitaria Pisana
Verified
Pisa, Italy
Universita Degli Studi Di Roma La Sapienza
Responsive
Rome, Italy

Trial locations

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Investigated drugs

APG-2575 (Lisaftoclax)
is an investigational medication being studied for the treatment of acute myeloid leukemia. It is designed to work in combination with other medications to treat blood cancer in elderly patients who have been newly diagnosed and cannot receive standard chemotherapy treatments.
Azacitidine (AZA)
is a medication used to treat certain types of blood cancers. It works by helping bone marrow produce normal blood cells and by killing abnormal cells in the blood and bone marrow. In this trial, it is being used in combination with APG-2575 to treat elderly patients with acute myeloid leukemia.

What is already known about the treatment

Lisaftoclax (APG-2575)
An investigational oral medication being studied for the treatment of acute myeloid leukemia (AML) in elderly patients. This drug belongs to the class of BCL-2 inhibitors, which work by promoting programmed cell death in cancer cells by blocking the BCL-2 protein that helps cancer cells survive. The medication is currently being evaluated in phase 3 clinical trials in combination with azacitidine for newly diagnosed AML patients who cannot receive standard chemotherapy due to age or other factors.
Azacitidine
A chemotherapy medication administered by injection or intravenous infusion, used in the treatment of myelodysplastic syndromes and acute myeloid leukemia. It belongs to the class of drugs called DNA methyltransferase inhibitors, which work by preventing the production of DNA in cancer cells and helping to restore normal blood cell production in the bone marrow. This medication is particularly important for elderly patients who cannot tolerate more aggressive forms of chemotherapy and is often used in combination with other targeted therapies.

Investigated diseases

Acute myeloid leukemia - A type of blood and bone marrow cancer that progresses rapidly. The disease begins in the bone marrow where abnormal white blood cells grow uncontrollably, interfering with normal blood cell production. These abnormal cells build up in the bone marrow and blood, reducing the body's ability to fight infections and maintain healthy blood cell counts. The condition affects the myeloid line of blood cells, which normally develop into various types of mature blood cells.