Tests lisaftoclax with a BTK inhibitor in adults with previously treated CLL or SLL
Tests lisaftoclax with a BTK inhibitor in adults with CLL or SLL.
Plain-language title generated from the registry record
Registry title: Global Trial in APG2575 for Patients With CLL/SLL
Key facts
- Where
- Aviano, Brescia, Ferrara, Genoa, Lecce, Meldola, Milan, Padova, Perugia, Piacenza, Ravenna, Reggio Emilia, Rimini, Rome, Rozzano, Turin, and Varese, ItalySee the 20 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 99 years old?
Source: NCT06104566, who can take part
Where in Italy
- Centro di Riferimento Oncologico di AvianoAviano, ItalyTaking people
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBrescia, ItalyTaking people
- University Hospital Of FerraraFerrara, ItalyTaking people
- IRCCS Ospedale Policlinico San MartinoGenoa, ItalyTaking people
- Ospedale Vito Fazzi LecceLecce, ItalyTaking people
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.lMeldola, ItalyTaking people
- ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyTaking people
- Istituto Europeo di Oncologia s.r.lMilan, ItalyTaking people
- Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
- Azienda Ospedale Universita PadovaPadova, ItalyTaking people
- Hospital Santa Maria Della MisericordiaPerugia, ItalyTaking people
- Azienda Unita Sanitaria Locale Di PiacenzaPiacenza, ItalyTaking people
- Azienda Unità Sanitaria Locale della RomagnaRavenna, ItalyTaking people
- Azienda USL IRCCS di Reggio EmiliaReggio Emilia, ItalyTaking people
- Azienda Unita Sanitaria Locale Della RomagnaRimini, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
- Università Campus Bio-Medico di RomaRome, ItalyTaking people
- Humanitas Mirasole S.p.A.Rozzano, ItalyTaking people
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, ItalyTaking people
- Azienda Socio Sanitaria Territoriale Dei Sette LaghiVarese, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ascentage Pharma Group Inc.
- Trial code
- NCT06104566EU 2023-508005-24-00
- Record updated
- 18 June 2026
- Original description
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 inhibitorsRead full original descriptionShow less
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 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: 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.