Recruiting NCT06104566

Global Trial in APG2575 for Patients With CLL/SLL

Phase III Interventional CLL/SLL

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: lisaftoclax +BTK inhibitor, BTK inhibitor.
Who it may be relevant to: Registry conditions: CLL/SLL. Basic parameters: 18 years — 99 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Belgium, Bulgaria, Canada +14
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Global Multicenter, Open Label, Randomized Phase 3 Registrational Study of Lisaftoclax (APG-2575) in Previously Treated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (GLORA Study)

Overview

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.

Interventions

Drug lisaftoclax +BTK inhibitor
lisaftolax + BTK inhibitor
Drug BTK inhibitor
BTK inhibitor

Primary outcome measures

PFS [Time frame: 12 months]

Secondary outcome measures (1)

overall survival [Time frame: 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment

Study locations

China · 19 centers

Ascentage Investigative Site — Hefei
Ascentage Investigative Site — Beijing
Ascentage Investigative Site — Fuzhou
Ascentage Investigative Site — Foshan
Ascentage Investigative Site — Guangzhou
Ascentage Investigative Site — Nanning
Ascentage Investigative Site — Zhengzhou
Ascentage Investigative Site — Wuhan
… and 11 more centers

India · 18 centers

Ascentage Investigative Site — Gandhinagar
Ascentage Investigative Site — Gurugramam
Ascentage Investigative Site — Gurugramam
Ascentage Investigative Site — Jhajjar
Ascentage Investigative Site — Bangalore
Ascentage Investigative Site — Mysuru
Ascentage Investigative Site — Navi Mumbai
Ascentage Investigative Site — Pune
… and 10 more centers

Italy · 17 centers