Actively Recruiting

Phase 3
Age: 18Years - 99Years
All Genders
NCT06104566

Global Trial in APG2575 for Patients With CLL/SLL

Led by Ascentage Pharma Group Inc. · Updated on 2025-09-18

400

Participants Needed

2

Research Sites

201 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Global Trial in APG2575 for Patients With CLL/SLL

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Documented CLL/SLL meeting iwCLL 2018 criteria and receiving BTKi monotherapy for at least 12 months
  • ECOG Performance Status grade 0 to 2
  • Adequate bone marrow function with absolute neutrophil count ≥ 1.0 x 10^9/L, platelet counts ≥ 75 x 10^9/L, and hemoglobin ≥ 9 g/dL
  • Adequate renal function with creatinine clearance > 50 ml/min or normal creatinine values
  • Adequate liver function with total bilirubin ≤ 1.5 x ULN (except Gilbert's Syndrome), AST ≤ 2.5 x ULN, ALT ≤ 2.5 x ULN, and coagulation tests ≤ 1.5 x ULN
  • Ability and willingness to provide informed consent and follow study schedule
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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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

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Research Team

L

Laura Glass

CONTACT

Y

Yifan Zhai, MD

CONTACT

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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