Approximately 440 patients will be enrolled, the patients who meet the eligibility criteria will be randomized in a 1:1 ratio to investigational arm (lisaftoclax in combination with a BTK inhibitor) or the control arm (BTK inhibitor alone). These patients with CLL/SLL have been on BTKi monotherapy and meet all other protocol required eligibility criteria.
Age
18–99
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
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
Clareo Health | Global Trial in APG2575 for Patients With CLL/SLL
