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

Recruiting now · Phase 3

Conditions studied: CLL/SLL

In brief

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.

Key facts

Study ID

NCT06319456

Run by

Ascentage Pharma Group Inc.

People needed

344

Starts

2024-04-07

Expected to finish

2028-08-01

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Any previous CLL specific treatment.
• Failure to fully recover adequately from prior surgical procedures at the discretion of the investigator. Patients who receive a major surgery within 28 days prior to the first dose of the study drug or who receive a minor surgery (excluding biopsy) within 14 days prior to the initiation of the study.
• Presence of significant cardiovascular disease within 6 months prior to study entry.
• A history of significant kidney, neurological, psychiatric, pulmonary, endocrine, metabolic, immune, cardiovascular, or liver disease, which will have an adverse effect on the patient if he/she participates in the study, at the discretion of the investigator.
• Patients who require warfarin or other anticoagulants or active hemorrhage occur within 2 months before study entry.
• Known to have hypersensitivity to the drug ingredient or its analogues.
• Pregnant or lactating female patients and patients who are expected to become pregnant during the study period or within 3 months after the last dose.
• Patients who have history of other active malignant tumor other than CLL/SLL within 3 years before study entry.
• With a malabsorption syndrome or other conditions unsuitable for enteral administration.
• Other clinically significant uncontrolled symptoms.
• With primary active autoimmune disease and connective tissue disease.
• Any other circumstances or conditions that would, at the discretion of the investigator, make the patient unsuitable for the study.

Where it is running

• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (enrolling)
• Henan Provincial Cancer Hospital — Zhengzhou, Henan, China (enrolling)
• Nanfang Hospital of Southern Medical University — Guangzhou, Guangdong, China (enrolling)
• Hematology Hospital of the Chinese Academy of Medical Sciences — Tianjin, Tianjin Municipality, China (enrolling)
• The Second Xiangya Hospital of Center South University — Changsha, Hunan, China
• Tongji Hospital of Tongji University — Shanghai, Shanghai Municipality, China
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China
• The affiliated Hospital of Guangdong Medical University — Zhanjiang, Guangdong, China
• The First Affiliated Hospital of Bengbu Medical College — Bengbu, Anhui, China
• Hunan Cancer Hospital — Changsha, Hunan, China

Full record on ClinicalTrials.gov

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