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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have already been treated with a BTK inhibitor alone for at least 12 months.
- Age
- 18 to 99 years
- Sex
- All sexes can join.
- Disease stage
- CLL/SLL that meets the iwCLL 2018 criteria for starting treatment. ECOG performance status of 0-2.
- Earlier treatment
- Must have received BTK inhibitor treatment alone (monotherapy) for at least 12 months.
Main reasons for not taking part
- Low blood counts: neutrophils below 1.0 × 109/L, platelets below 75 × 109/L, or hemoglobin below 9 g/dL
- Kidney function too low: creatinine clearance of 50 ml/min or less
- Liver tests too high: total bilirubin above 1.5 x ULN, or AST or ALT above 2.5 x ULN
- Blood clotting tests (INR, PT or APTT) above 1.5×ULN
- Cannot give written informed consent or follow the study visit schedule
Read by machine on 13 November 2026.
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.