Global Trial in APG2575 for Patients With CLL/SLL

NCT ID: NCT06104566

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-20
• Study Completion Date: 2027-10-31

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

Detailed Description

Approximately 440 patients will be enrolled, the patients who meet the eligibility criteria will be randomized in a 1:1 ratio to investigational arm (lisaftoclax in combination with a BTK inhibitor) or the control arm (BTK inhibitor alone). These patients with CLL/SLL have been on BTKi monotherapy and meet all other protocol required eligibility criteria.

Conditions

CLL/SLL

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Combination therapy

Group Type: ACTIVE_COMPARATOR

lisaftoclax +BTK inhibitor

Intervention Type: DRUG

lisaftolax + BTK inhibitor

Arm 2

mono therapy

Group Type: ACTIVE_COMPARATOR

BTK inhibitor

Intervention Type: DRUG

BTK inhibitor

Interventions

lisaftoclax +BTK inhibitor

lisaftolax + BTK inhibitor

Intervention Type: DRUG

BTK inhibitor

BTK inhibitor

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ascentage Pharma Group Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

MD Anderson Cancer Center

Houston, Texas, United States

Site Status: RECRUITING

Kaluga Regional Clinical Research

Kaluga, , Russia

Site Status: RECRUITING

Countries

United States; Russia

Central Contacts

Laura Glass

Role: CONTACT

laura.glass@ascentage.com

301-520-5964

Yifan Zhai, MD

Role: CONTACT

yzhai@ascentage.com

301-549-6188

Other Identifiers

APG2575CG301

Identifier Type: -

Identifier Source: org_study_id