Clinical trial NCT06104566: Global Trial in APG2575 for Patients With CLL/SLL
Official title: 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 (GLORA Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: CLL/SLL
Lead sponsor: Ascentage Pharma Group Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-27
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 ratio to investigational arm (lisaftoclax in combination with BTKi ) or the control arm (BTKi).
Primary purpose: TREATMENT

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

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.

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

Primary outcomes:
measure: PFS
timeFrame: 12 months
Secondary outcomes:
measure: overall survival
timeFrame: 12 months
Other outcomes:
Locations:
city: Kaluga
country: Russian Federation
facility: Kaluga Regional Clinical Research
Study officials:
References: