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Clinical Trials in Australia / NCT06104566
Recruiting Phase 3

Global Trial in APG2575 for Patients With CLL/SLL

NCT06104566 · tracked via the Priya Life Science Australia tracker
Phase
Phase 3
Started
2023-12-20
Last updated
2026-06-18

Condition(s) studied

CLL/SLL

Investigational drug(s) / intervention(s)

lisaftoclax +BTK inhibitor →BTK inhibitor

lisaftoclax +BTK inhibitor: lisaftolax + BTK inhibitor

BTK inhibitor: BTK inhibitor

Study 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

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 18 years. 2. Patients that have documented CLL/SLL who meet iwCLL 2018 criteria for CLL treatment guidelines are eligible for treatment and must be receiving BTKi monotherapy for at least 12 months 3. ECOG Performance Status grade 0-2 4. Adequate bone marrow function independent of growth factor or transfusion support within 2 weeks of screening initiation as follows: * Absolute neutrophil count ≥ 1.0 × 109/L * Platelet counts ≥ 75 × 109/L; in cases of thrombocytopenia * Total hemoglobin ≥ 9 g/dL, 5. Adequate renal function * Creatinine clearance must be \> 50 ml/min directly measured with 24hr urine collection or calculated according to the modified formula of Cockcroft and Gault (for men: GFR ≈ ((140 - age) x actual body weight)/(72 x creatinine), for women x 0.85) or an equally accurate method. * For patients with creatinine values within the normal range, the calculation of clearance is not necessary. Dehydrated patients with an estimated creatinine clearance less than 50 ml/min may be eligible if a repeat estimate after adequate hydration is \> 50 ml/min. 6. Adequate liver function as indicated by: * Total bilirubin ≤ 1.5 x ULN, except patients with known Gilbert's Syndrome * Aspartate aminotransferase (AST) ≤ 2.5 x the institutional ULN value * Alanine aminotransferase (ALT) ≤ 2.5 x the institutional ULN value, * International normalized Ratio (INR), Prothrombin Time (PT) or Activated Partial Thromboplastin time (APTT) ≤ 1.5×ULN. 7. Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements

Primary outcome measure(s)

Trial sites (135)

FacilityCityRegionStatus
Ascentage Investigative Site Tuscon Arizona Recruiting
Ascentage Investigative Site Anaheim California Recruiting
Ascentage Investigative Site Jacksonville Florida Recruiting
Ascentage Investigative Site Miami Beach Florida Recruiting
Ascentage Investigative Site Peoria Illinois Recruiting
Ascentage Investigative Site Boston Massachusetts Recruiting
Ascentage Investigative Site Ann Arbor Michigan Recruiting
Ascentage Investigative Site Greenville North Carolina Recruiting
Ascentage Investigative Site Houston Texas Recruiting
Ascentage Investigative Site Kingswood Texas Recruiting
Ascentage Investigative Site Richmond Virginia Recruiting
Ascentage Investigative Site Gosford Australia Completed
Ascentage Investigative Site Perth Australia Completed
Ascentage Investigative Site Westmead Australia Completed
Ascentage Investigative Site Ghent Belgium Recruiting
Ascentage Investigative Site La Louvière Belgium Recruiting
Ascentage Investigative Site Leuven Belgium Recruiting
Ascentage Investigative Site Ottignies Belgium Recruiting
Ascentage Investigative Site Roeselare Belgium Recruiting
Ascentage Investigative Site Sofia Bulgaria Recruiting
Ascentage Investigative Site Sofia Bulgaria Recruiting
Ascentage Investigative Site Sofia Bulgaria Recruiting
Ascentage Investigative Site Sofia Bulgaria Recruiting
Ascentage Investigative Site Halifax Nova Scotia Recruiting
Ascentage Investigative Site Hefei Anhui Recruiting
Ascentage Investigative Site Beijing Beijing Municipality Recruiting
Ascentage Investigative Site Fuzhou Fujian Recruiting
Ascentage Investigative Site Foshan Guangdong Recruiting
Ascentage Investigative Site Guangzhou Guangdong Recruiting
Ascentage Investigative Site Nanning Guangxie Recruiting
Ascentage Investigative Site Zhengzhou Henan Recruiting
Ascentage Investigative Site Wuhan Hubei Recruiting
Ascentage Investigative Site Chenzhou Hunan Recruiting
Ascentage Investigative Site Nanjing Jiangsu Recruiting
Ascentage Investigative Site Suzhou Jiangsu Recruiting
Ascentage Investigative Site Wuxi Jiangsu Recruiting
Ascentage Investigative Site Nanchang Jiangxi Recruiting
Ascentage Investigative Site Xi'an Shaanxi Recruiting
Ascentage Investigative Site Binzhou Shandong Recruiting
Ascentage Investigative Site Taiyuan Shanxi Recruiting

+ 95 more sites — see the full list on the official registry below.

More Ascentage Pharma Group Inc. trials in Australia

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06104566 on ClinicalTrials.gov ↗ ← All trials in Australia