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Global Trial in APG2575 for Patients With CLL/SLL
RecruitingPhase 3
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)
Who can join
Ages 18 to 99 · All sexes
Full eligibility criteria
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
About the study
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
What is being tested
- lisaftoclax +BTK inhibitor (drug)
- BTK inhibitor (drug)
Sponsor: Ascentage Pharma Group Inc. · Participants: 400 · Started: Dec 20, 2023
Contact the study team
- Shanthi Marur, MD · Phone: 3017925062
- Yifan Zhai, MD · Phone: 301-549-6188
Official record on ClinicalTrials.gov — NCT06104566
Locations in the U.S.
| Arizona | Ascentage Investigative Site, Tuscon |
| California | Ascentage Investigative Site, Anaheim |
| Florida | Ascentage Investigative Site, Jacksonville Ascentage Investigative Site, Miami Beach |
| Illinois | Ascentage Investigative Site, Peoria |
| Massachusetts | Ascentage Investigative Site, Boston |
| Michigan | Ascentage Investigative Site, Ann Arbor |
| North Carolina | Ascentage Investigative Site, Greenville |
| Texas | Ascentage Investigative Site, Houston Ascentage Investigative Site, Kingswood |
| Virginia | Ascentage Investigative Site, Richmond |
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.