Global Trial in APG2575 for Patients With CLL/SLL
Study Details
Study Description
Brief 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Arm 1 Combination therapy |
Drug: lisaftoclax +BTK inhibitor
lisaftolax + BTK inhibitor
|
| Active Comparator: Arm 2 mono therapy |
Drug: BTK inhibitor
BTK inhibitor
|
Outcome Measures
Primary Outcome Measures
- PFS [12 months]
To evaluate the progression-free survival (PFS) of lisaftoclax in combination with BTKi compared with BTKi monotherapy in CLL/SLL patients previously treated with BTKi as determined by independent radiological review committee (IRC) using the iwCLL guidelines
Secondary Outcome Measures
- overall survival [12 months]
To evaluate overall survival (OS) of lisaftoclax in combination with BTKi versus BTKi
Eligibility Criteria
Criteria
Inclusion Criteria:
-
- Age ≥ 18 years.
-
. 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
-
ECOG Performance Status grade 0-2
-
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,
- 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.
- 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.
- Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements
Exclusion Criteria:
-
- 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.
- 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.
- Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Ascentage Pharma Group Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- APG2575CG301