Global Trial in APG2575 for Patients With CLL/SLL

NCT06104566 | Recruiting Phase 3 FDA Drug

• 1 other identifier: APG2575CG301
• Study Type: interventional
• Target: 400
• Locations: 2 countries
• Sites: 2

Brief Summary

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

CLL/SLL

Outcome Measures

Primary Outcomes (1)

• PFS

  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

  12 months

Secondary Outcomes (1)

• overall survival

  12 months

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Combination therapy

Drug: lisaftoclax +BTK inhibitor

Arm 2

ACTIVE COMPARATOR

mono therapy

Drug: BTK inhibitor

Interventions

lisaftoclax +BTK inhibitor DRUG

lisaftolax + BTK inhibitor

Arm 1

BTK inhibitor DRUG

BTK inhibitor

Arm 2

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Age ≥ 18 years.
• 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
• ECOG Performance Status grade 0-2
• 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,
• 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.
• 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.

Sponsors & Collaborators

• Ascentage Pharma Group Inc.: lead

Study Sites (2)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Kaluga Regional Clinical Research

Kaluga, 246007, Russia

RECRUITING

Central Study Contacts

Laura Glass

CONTACT

301-520-5964; laura.glass@ascentage.com

Yifan Zhai, MD

CONTACT

301-549-6188; yzhai@ascentage.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1:1 ratio to investigational arm (lisaftoclax in combination with BTKi ) or the control arm (BTKi).

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 27, 2023
• Study Start: December 20, 2023
• Primary Completion: October 20, 2025
• Study Completion (Estimated): October 31, 2027
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

US (1); RU (1)