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Global Trial in APG2575 for Patients With CLL/SLL
Global Trial in APG2575 for Patients With CLL/SLL

NCT06104566

RecruitingPhase 3

Sponsor: Ascentage Pharma Group Inc.

Conditions: CLL/SLL

Interventions: lisaftoclax +BTK inhibitor, BTK inhibitor

Countries: United States, Australia, Belgium, Bulgaria, Canada, China, Czechia, France

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 overview

Sex: ALL

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (135)
  • Tuscon, Arizona, United States
  • Anaheim, California, United States
  • Jacksonville, Florida, United States
  • Miami Beach, Florida, United States
  • Peoria, Illinois, United States
  • Boston, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Greenville, North Carolina, United States
  • Houston, Texas, United States
  • Kingswood, Texas, United States
  • Richmond, Virginia, United States
  • Gosford, Australia
  • Perth, Australia
  • Westmead, Australia
  • Ghent, Belgium
  • La Louvière, Belgium
  • Leuven, Belgium
  • Ottignies, Belgium
  • Roeselare, Belgium
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Halifax, Nova Scotia, Canada
  • Hefei, Anhui, China
  • Beijing, Beijing Municipality, China
  • Fuzhou, Fujian, China
  • Foshan, Guangdong, China
  • Guangzhou, Guangdong, China
  • Nanning, Guangxie, China
  • + 105 more on CT.gov