RecruitingPhase 3NCT06104566

Global Trial in APG2575 for Patients With CLL/SLL

A Global Multicenter, Open Label, Randomized Phase 3 Registrational Study of Lisaftoclax (APG-2575) in Previously Treated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (GLORA Study)


Sponsor

Ascentage Pharma Group Inc.

Enrollment

400 participants

Start Date

Dec 20, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a global multicenter, open label, randomized, registrational phase III study to investigate the efficacy and safety of lisaftoclax in combination with BTK inhibitors in CLL/SLL patients who previously treated with BTK inhibitors


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This global trial is testing APG2575 (lisaftoclax), a targeted drug, in people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who are already being treated with a BTK inhibitor (a common targeted therapy for this cancer type). The goal is to see if adding APG2575 to ongoing BTK inhibitor treatment improves outcomes. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of CLL or SLL - You have been on a BTK inhibitor (like ibrutinib or acalabrutinib) as your only treatment for at least 12 months - Your blood counts and organ function are within acceptable ranges - Your general health is adequate (ECOG 0–2) **You may NOT be eligible if...** - You are not responding well to your current BTK inhibitor treatment - Your blood counts are very low and not improving - You have severely reduced kidney or liver function 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

DRUGlisaftoclax +BTK inhibitor

lisaftolax + BTK inhibitor

DRUGBTK inhibitor

BTK inhibitor


Locations(2)

MD Anderson Cancer Center

Houston, Texas, United States

Kaluga Regional Clinical Research

Kaluga, Russia

View Full Details on ClinicalTrials.gov

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NCT06104566


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