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Global Trial in APG2575 for Patients With CLL/SLL
Trial Status: active
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
Inclusion 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
Additional locations may be listed on ClinicalTrials.gov for NCT06104566.
Locations matching your search criteria
United States
Arizona
Tucson
Banner University Medical Center - Tucson
Status: Active
Name Not Available
Florida
Jacksonville
Mayo Clinic in Florida
Status: Active
Name Not Available
Massachusetts
Boston
Dana-Farber Cancer Institute
Status: Active
Name Not Available
Brigham and Women's Hospital
Status: Active
Name Not Available
Michigan
Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: Active
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Active
Name Not Available
Virginia
Richmond
VCU Massey Comprehensive Cancer Center
Status: Active
Name Not Available
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