Global Trial in APG2575 for Patients With CLL/SLL
Recruiting now · Phase 3
Conditions studied: CLL/SLL
In brief
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
Key facts
- Study ID
- NCT06104566
- Run by
- Ascentage Pharma Group Inc.
- People needed
- 400
- Starts
- 2023-12-20
- Expected to finish
- 2027-10-31
- Last updated by the study team
- 2026-06-18
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years.
- 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
- ECOG Performance Status grade 0-2
- 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,
- 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.
- 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.
- Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements
Where it is running
- Ascentage Investigative Site — Anaheim, California, United States (enrolling)
- Ascentage Investigative Site — Fuzhou, Fujian, China (enrolling)
- Ascentage Investigative Site — Miami Beach, Florida, United States (enrolling)
- Ascentage Investigative Site — Peoria, Illinois, United States (enrolling)
- Ascentage Investigative Site — Tuscon, Arizona, United States (enrolling)
- Ascentage Investigative Site — Beijing, Beijing Municipality, China (enrolling)
- Ascentage Investigative Site — Greenville, North Carolina, United States (enrolling)
- Ascentage Investigative Site — Houston, Texas, United States (enrolling)
- Ascentage Investigative Site — Kingswood, Texas, United States (enrolling)
- Ascentage Investigative Site — Richmond, Virginia, United States (enrolling)
- Ascentage Investigative Site — Boston, Massachusetts, United States (enrolling)
- Ascentage Investigative Site — Jacksonville, Florida, United States (enrolling)
- Ascentage Investigative Site — Ann Arbor, Michigan, United States (enrolling)
- Ascentage Investigative Site — Ghent, Belgium (enrolling)
- Ascentage Investigative Site — La Louvière, Belgium (enrolling)
- Ascentage Investigative Site — Leuven, Belgium (enrolling)
- Ascentage Investigative Site — Ottignies, Belgium (enrolling)
- Ascentage Investigative Site — Roeselare, Belgium (enrolling)
- Ascentage Investigative Site — Sofia, Bulgaria (enrolling)
- Ascentage Investigative Site — Sofia, Bulgaria (enrolling)
- Ascentage Investigative Site — Sofia, Bulgaria (enrolling)
- Ascentage Investigative Site — Sofia, Bulgaria (enrolling)
- Ascentage Investigative Site — Halifax, Nova Scotia, Canada (enrolling)
- Ascentage Investigative Site — Hefei, Anhui, China (enrolling)
- Ascentage Investigative Site — Foshan, Guangdong, China (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.