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RECRUITING
NCT06319456
PHASE3

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

Sponsor: Ascentage Pharma Group Inc.

View on ClinicalTrials.gov

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.

Official title: 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).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

344

Start Date

2024-04-07

Completion Date

2028-08

Last Updated

2024-05-29

Healthy Volunteers

No

Conditions

Interventions

DRUG

Lisaftoclax (APG-2575)

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

DRUG

Acalabrutinib

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

DRUG

Fludarabine

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

DRUG

Cyclophosphamide,CTX

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

DRUG

Rituximab

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

DRUG

Chlorambucil

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