RecruitingPhase 3NCT06319456

A Global Study of Lisaftoclax (APG-2575) Combined With Acalabrutinib Versus Immunochemotherapy for Newly Diagnosed CLL/SLL.

A Global Multicenter, Open Label, Randomized Phase III Confirmatory Study of Lisaftoclax (APG-2575) in Combination With Acalabrutinib Versus Immunochemotherapy in Patients With Newly Diagnosed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (GLORA-2).

Sponsor

Ascentage Pharma Group Inc.

Enrollment

344 participants

Start Date

Apr 7, 2024

Study Type

INTERVENTIONAL

Conditions

CLL/SLL

Summary

This is a global, multicenter, randomized, open-label, Phase III confirmatory study to investigate the efficacy and safety of Lisaftoclax (APG-2575) in combination with Acalabrutinib in patients with newly diagnosed CLL/SLL.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This global study compares a new drug combination — lisaftoclax (APG-2575) plus acalabrutinib — to standard immunochemotherapy in patients newly diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), two closely related blood cancers. **You may be eligible if...** - You have been newly diagnosed with CLL or SLL that requires treatment - Your cancer is measurable - Your general health score is 0 to 2 (ECOG) - Your heart rhythm (QTc interval) is within normal range - You have adequate bone marrow, liver, kidney, and clotting function **You may NOT be eligible if...** - You have already received treatment for CLL or SLL - You have serious heart conditions or uncontrolled infections - You have active central nervous system involvement of your leukemia - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLisaftoclax (APG-2575)

QD, oral administration, every 28 days for a dosing cycle.

DRUGAcalabrutinib

BID, oral administration, every 28 days for a dosing cycle.

DRUGFludarabine

Every 28 days for a treatment cycle, administration of 6 cycles.

DRUGCyclophosphamide，CTX

Every 28 days for a treatment cycle, administration of 6 cycles.

DRUGRituximab

Every 28 days for a treatment cycle, administration of 6 cycles.

DRUGChlorambucil

Every 28 days for a treatment cycle, administration of 6 cycles.

Locations(6)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Henan Provincial Cancer Hospital

Zhengzhou, Henan, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Hematology Hospital of the Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06319456

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