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Status:

RECRUITING

Global Trial in APG2575 for Patients With CLL/SLL

Lead Sponsor:

Ascentage Pharma Group Inc.

Conditions:

CLL/SLL

Eligibility:

All Genders

18-99 years

Phase:

PHASE3

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 pr...

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) o...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • \- 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.
  • Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements

Exclusion

    Key Trial Info

    Start Date :

    December 20 2023

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    October 31 2027

    Estimated Enrollment :

    400 Patients enrolled

    Trial Details

    Trial ID

    NCT06104566

    Start Date

    December 20 2023

    End Date

    October 31 2027

    Last Update

    September 18 2025

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    MD Anderson Cancer Center

    Houston, Texas, United States, 77030

    2

    Kaluga Regional Clinical Research

    Kaluga, Russia, 246007