For USA Only
Global Phase 3 Clinical Trial for Lisaftoclax* (APG-2575) in Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Contact UsA new medicine called Lisaftoclax (APG-2575) is being studied in combination with Acalabrutinib to see if it works better than Acalabrutinib alone.
This clinical trial is for people who have already been treated for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and are still living with their disease.
Lisaftoclax works by blocking a protein (called BCL-2) that helps cancer cells survive.
Stopping this protein may help the cancer cells die
and make other treatments work better.
Study Design
Global, multicenter, Phase 3 trial
440 patients with CLL/SLL who have previously been treated with Acalabrutinib for 12 months and more
Lisaftoclax combined with Acalabrutinib
Acalabrutinib alone
The study aims to evaluate
How long patients live without disease progression
Monitoring to ensure patient safety
Total survival time
How the treatment affects daily life
You will be randomly assigned similar to a coin toss – to one of the treatment groups (to continue receiving Acalabrutinib alone or have lisaftoclax added to their treatment).
If you receive Lisaftoclax, you will begin with a small dose that gradually increases over 5 days. This is called a ramp-up period, and it’s designed to help your body adjust to the treatment safely and lower the risk of side effects.
At the end of the ramp-up, you’ll reach your Target Dose — this is the full dose of Lisaftoclax that you’ll continue taking for the rest of the study, as long as it’s working well for you and you’re tolerating it.
Throughout the trial, the study team will regularly check your health, perform lab tests, and ask how you’re feeling.
Most people can take part as outpatients (without needing to stay in the hospital). In some cases, especially during the first few days of treatment, a short hospital stay may be recommended for extra monitoring.
You may be eligible for this clinical trial.
Please fill out the form to contact us for further assistance.
Unfortunately, You May Not Be Eligible for This Clinical Trial.
Based on the information you’ve provided, it looks like you may not meet the current eligibility criteria for this study.
This trial is evaluating the safety and effectiveness of Lisaftoclax (APG-2575) in combination with Acalabrutinib compared to Acalabrutinib alone in patients with previously treated Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).
Patients aged 18 years or older with a confirmed diagnosis of CLL/SLL who have been treated with Acalabrutinib for at least 12 months and have stable disease (SD) or partial response (PR) may be eligible. Other medical criteria apply, including liver and kidney function assessments.
Participants will continue treatment until disease progression, unacceptable side effects, withdrawal from the study, or completion of the study, which may last up to 7 years.
Lisaftoclax is an investigational drug designed to block BCL-2, a protein that helps cancer cells survive. It is taken orally once daily.
Lisaftoclax is an investigational drug and is not yet approved by FDA.
Lisaftoclax is taken orally, starting with a 5-day ramp-up phase to gradually increase the dose to 400 mg per day. Acalabrutinib is taken twice daily as a pill.
Most patients will take the medication at home, but those at high risk for Tumor Lysis Syndrome (TLS) may require monitoring in a hospital during the ramp-up phase.
Common side effects include:
Serious side effects are closely monitored, and dose adjustments may be made to minimize risks.
The medical team will assess your condition and may adjust your dosage, pause treatment, or discontinue medication if necessary.
Yes, you can withdraw at any time without affecting your standard medical care.
Your doctor will discuss ongoing treatment options and whether you may continue receiving Lisaftoclax if it proves clinically beneficial.
