Investigating a new treatment for patients with CLL/SLL

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)

This study is testing if a new treatment combining lisaftoclax with BTK inhibitors can help people with chronic lymphocytic leukemia or small lymphocytic lymphoma who have already been treated with BTK inhibitors.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Ascentage Pharma Group Inc. (Industry-sponsored)
• Locations: 2 sites (Houston, Texas and 1 other locations)
• Trial ID: NCT06104566 on ClinicalTrials.gov

What this trial studies

This global multicenter, open-label, randomized phase III study aims to evaluate the efficacy and safety of lisaftoclax in combination with BTK inhibitors for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously been treated with BTK inhibitors. Approximately 440 eligible patients will be randomly assigned in a 1:1 ratio to receive either the combination treatment or a BTK inhibitor alone. The study focuses on patients who have been on BTK inhibitor monotherapy for at least 12 months and meet specific eligibility criteria related to their health status and laboratory values.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with documented CLL/SLL who have been on BTK inhibitor monotherapy for at least 12 months.

Not a fit: Patients who have not been treated with BTK inhibitors or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with CLL/SLL who have not responded adequately to existing therapies.

How similar studies have performed: Other studies have shown promising results with similar combination therapies in CLL/SLL, indicating potential for success in this approach.

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

Where this trial is running

Houston, Texas and 1 other locations

• MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
• Kaluga Regional Clinical Research — Kaluga, Russia (Recruiting)

Study contacts

• Study coordinator: Laura Glass

Conditions CLL/SLL