🔎 Trials Near Me

Home › NCT06104566

Global Trial in APG2575 for Patients With CLL/SLL

RecruitingPhase 3

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)

Who can join

Ages 18 to 99 · All sexes

Full 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

About the 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

What is being tested

Sponsor: Ascentage Pharma Group Inc. · Participants: 400 · Started: Dec 20, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT06104566

Locations in the U.S.

ArizonaAscentage Investigative Site, Tuscon
CaliforniaAscentage Investigative Site, Anaheim
FloridaAscentage Investigative Site, Jacksonville
Ascentage Investigative Site, Miami Beach
IllinoisAscentage Investigative Site, Peoria
MassachusettsAscentage Investigative Site, Boston
MichiganAscentage Investigative Site, Ann Arbor
North CarolinaAscentage Investigative Site, Greenville
TexasAscentage Investigative Site, Houston
Ascentage Investigative Site, Kingswood
VirginiaAscentage Investigative Site, Richmond

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.