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Global Trial in APG2575 for Patients With CLL/SLL

This study is testing a new combination treatment for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Researchers want to see if adding lisaftoclax to a BTK inhibitor (a type of drug you might already be taking) works better than a BTK inhibitor alone. You could be eligible if you are 18 to 99 years old, have CLL/SLL, and have been taking a BTK inhibitor by itself for at least 12 months. The main goal is to see how long people live without their disease getting worse (PFS, or progression-free survival) at 12 months. The study is currently recruiting about 400 people worldwide.

Study design
This is a global, open-label (you and your doctor will know which treatment you are receiving), randomized study. About 440 participants will be randomly assigned to receive either lisaftoclax plus a BTK inhibitor, or a BTK inhibitor alone.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, progression-free survival (PFS), will be measured at 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06104566

Global Trial in APG2575 for Patients With CLL/SLL

Recruiting
PHASE3Ages 18–99InterventionalTreatment
Ascentage Pharma Group Inc.
~400 participants
Updated 2026-06-18 on ClinicalTrials.gov
What's tested:lisaftoclax +BTK inhibitorBTK inhibitor

At a glance

Recruiting sites
120 of 135 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
PFS
Measured over 12 months

Conditions

CLL/SLL

Explore related trials

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

NCT06104566

Where you'd take part

This study runs at 135 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Ascentage Investigative Site

    Tuscon, Arizonano site contact published

    Recruiting

  • Ascentage Investigative Site

    Anaheim, Californiano site contact published

    Recruiting

  • Ascentage Investigative Site

    Jacksonville, Floridano site contact published

    Recruiting

  • Ascentage Investigative Site

    Miami Beach, Floridano site contact published

    Recruiting

  • Ascentage Investigative Site

    Peoria, Illinoisno site contact published

    Recruiting

  • Ascentage Investigative Site

    Boston, Massachusettsno site contact published

    Recruiting

  • Ascentage Investigative Site

    Ann Arbor, Michiganno site contact published

    Recruiting

  • Ascentage Investigative Site

    Greenville, North Carolinano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Shanthi Marur, MD
[email protected]
3017925062
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

What this trial measures

  • PFS12 months

    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