Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 3
Ascentage Pharma Group Inc. (Voir sur ClinicalTrials)
décembre 2023
octobre 2027
24 juin 2026
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
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL NOVO | VAIDA | 18/09/2025 17:50:06 | Contacter | ||
Critères
Tous
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
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