Global Trial in APG2575 for Patients With CLL/SLL

CLL/SLL Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06104566
• Other study ID #: APG2575CG301
• Status: Recruiting
• Phase: Phase 3
• Start date: December 20, 2023
• Est. completion date: October 31, 2027

Study information

• Verified date: January 2024
• Source: Ascentage Pharma Group Inc.
• Contact: Laura Glass, MD
• Phone: 301-520-5964
• Email: laura.glass[@]ascentage.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: October 31, 2027
• Est. primary completion date: October 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• CLL/SLL

Intervention

Drug:
• lisaftoclax +BTK inhibitor
lisaftolax + BTK inhibitor
• BTK inhibitor
BTK inhibitor

Locations

Country	Name	City	State
Russian Federation	Kaluga Regional Clinical Research	Kaluga

Sponsors (1)

Lead Sponsor	Collaborator
Ascentage Pharma Group Inc.

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	overall survival	To evaluate overall survival (OS) of lisaftoclax in combination with BTKi versus BTKi	12 months