Clinical trial · Interventional
Global Trial in APG2575 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)
NCT06104566CI-TRIAL-00115238recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CLL/SLL | Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BTK inhibitor | Drug | — | UNRESOLVED |
| lisaftoclax +BTK inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1
- description
- Combination therapy
- interventionNames
- Drug: lisaftoclax +BTK inhibitor
- type
- ACTIVE_COMPARATOR
- label
- Arm 2
- description
- mono therapy
- interventionNames
- Drug: BTK inhibitor
Primary outcomes (1)
- measure
- PFS
- timeFrame
- 12 months
- description
- To evaluate the progression-free survival (PFS) of lisaftoclax in combination with BTKi compared with BTKi monotherapy in CLL/SLL patients previously treated with BTKi as determined by independent radiological review committee (IRC) using the iwCLL guidelines
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.