For USA Only
Global Phase 3 Clinical Trial for Lisaftoclax* (APG-2575)
in Chronic Lymphocytic Leukemia (CLL)/Small
Lymphocytic Lymphoma (SLL)
A 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.
A Global, Multicenter, Phase 3 Study of Lisaftoclax (APG-2575) for Patients with Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL)
This study investigates whether the addition of Lisaftoclax to acalabrutinib therapy can improve treatment outcomes in previously treated CLL/SLL patients.
Lisaftoclax requires just a 5-day dose escalation, compared to up to 6 weeks with other regimens like venetoclax.
This means faster treatment starts and less burden for patients and sites.
Combination therapy with Lisaftoclax (400 mg once daily following a ramp-up phase) and Acalabrutinib
Acalabrutinib monotherapy
Secondary Endpoint
Participating investigators will have access to a dedicated support team and detailed trial materials to ensure seamless patient management and data collection.
This collaborative approach aims to provide comprehensive data while maintaining the highest standards of patient care.
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:
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.
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