Actively Recruiting
Global Phase 3 Study of Lisaftoclax with BTK Inhibitors in Previously Treated CLL/SLL Patients
Led by Ascentage Pharma Group Inc. · Updated on 2025-09-18
400
Participants Needed
2
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial focuses on patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with BTK inhibitors. Researchers are evaluating the combination of lisaftoclax with BTK inhibitors compared to BTK inhibitor therapy alone to study efficacy and safety in this patient group. This is a global, open-label, randomized phase III trial aiming to provide registrational data for lisaftoclax. Approximately 440 patients who meet eligibility criteria will be randomly assigned in equal numbers to one of two groups: one receiving the combination of lisaftoclax plus a BTK inhibitor, and the other receiving only a BTK inhibitor. Patients must have been on BTK inhibitor monotherapy for at least 12 months prior to enrollment. The study is conducted at multiple centers worldwide and does not use blinding. Participants will be monitored over time to assess progression-free survival at 12 months as the primary outcome. Overall survival at 12 months will also be evaluated as a secondary outcome. Assessments include regular clinical visits, laboratory tests to confirm bone marrow, kidney, and liver function, and adherence to the treatment schedule. The study will continue until October 2027, ensuring thorough safety and efficacy observations.
CONDITIONS
Brief Title
Global Trial in APG2575 for Patients With CLL/SLL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with CLL/SLL meeting iwCLL 2018 treatment guidelines
- Receiving BTK inhibitor monotherapy for at least 12 months
- ECOG Performance Status of 0 to 2
- Adequate bone marrow function: absolute neutrophil count ≥ 1.0 x 10^9/L, platelet count ≥ 75 x 10^9/L, hemoglobin ≥ 9 g/dL
- Adequate kidney function with creatinine clearance > 50 ml/min
- Adequate liver function: total bilirubin ≤ 1.5 x ULN (except Gilbert's Syndrome), AST and ALT ≤ 2.5 x ULN, coagulation tests ≤ 1.5 x ULN
- Ability and willingness to provide written informed consent and adhere to study visits and protocol requirements
You will not qualify if you...
- None explicitly provided in the source
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 months
Participants receive either a combination of lisaftoclax with a BTK inhibitor or BTK inhibitor monotherapy as part of their treatment.
Trial Site Locations
Total: 2 locations
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
2
Kaluga Regional Clinical Research
Kaluga, Russia, 246007
Actively Recruiting
Research Team
L
Laura Glass
Y
Yifan Zhai, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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