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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

Primary Investigator
Malek, Sami
Status
OPEN TO ACCRUAL
Phase
III
NCT Number
NCT06104566
UM Number
2024.040
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Hematological Malignancies
ID (Protocol)
52336
Secondary Protocol No
HUM00252189
Scope
Unspecified
Sponsor Type
Industry
Disease Site
Lymphoid Leukemia
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: 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