Combining Lisaftoclax and Acalabrutinib 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).

This study is testing if a new combination of two drugs, Lisaftoclax and Acalabrutinib, can work better than standard treatment for people who have just been diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 344 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ascentage Pharma Group Inc. (Industry-sponsored)
• Drugs / interventions: Acalabrutinib
• Locations: 6 sites (Bengbu, Anhui and 5 other locations)
• Trial ID: NCT06319456 on ClinicalTrials.gov

What this trial studies

This global, multicenter, randomized, open-label Phase III study aims to evaluate the efficacy and safety of Lisaftoclax (APG-2575) in combination with Acalabrutinib compared to standard immunochemotherapy in patients with newly diagnosed chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Eligible patients will be randomized into either the investigational group receiving the combination therapy or the control group receiving immunochemotherapy. The study will assess treatment outcomes and safety profiles to determine the potential advantages of the new combination therapy.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with CLL/SLL who meet specific eligibility criteria and require treatment.

Not a fit: Patients with CLL/SLL who do not meet the eligibility criteria or have advanced disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a more effective and safer option for patients with newly diagnosed CLL/SLL.

How similar studies have performed: Other studies have shown promising results with similar combination therapies in CLL/SLL, indicating potential for success.

Eligibility criteria

1. CLL/SLL must be diagnosed according to the IWCLL NCI-WG Guidelines (2018 edition) and meet at least one of the criteria requiring treatment.
2. With a measurable disease.
3. ECOG score 0-2.
4. QTcF interval: ≤450ms in males, ≤470ms in females.
5. Adequate bone marrow function independent of growth factor support.
6. Adequate liver, kidney and coagulation function.
7. Males and females of childbearing potential, and their partners voluntarily use effective contraceptive measures throughout the treatment and for at least three months after the last dose of the study drug. Male patients must avoid donation from the first dose of the study drug to three months after the last dose of the study drug.
8. Female patients of childbearing potential have negative serum pregnancy test results within 14 days prior to the first dose of the study drug.
9. Patients must be able to understand and voluntarily sign an informed consent form approved by the Ethics Committee (EC) before commencing any screening or study specific procedures.
10. Must be willing and able to complete research procedures and follow-up examinations.

Exclusion Criteria:

1. Any previous CLL specific treatment.
2. 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.
3. Presence of significant cardiovascular disease within 6 months prior to study entry.
4. 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.
5. Patients who require warfarin or other anticoagulants or active hemorrhage occur within 2 months before study entry.
6. Known to have hypersensitivity to the drug ingredient or its analogues.
7. 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.
8. Patients who have history of other active malignant tumor other than CLL/SLL within 3 years before study entry.
9. With a malabsorption syndrome or other conditions unsuitable for enteral administration.
10. Other clinically significant uncontrolled symptoms.
11. With primary active autoimmune disease and connective tissue disease.
12. Any other circumstances or conditions that would, at the discretion of the investigator, make the patient unsuitable for the study.

Where this trial is running

Bengbu, Anhui and 5 other locations

• The First Affiliated Hospital of Bengbu Medical College — Bengbu, Anhui, China (Not_yet_recruiting)
• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Nanfang Hospital of Southern Medical University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Henan Provincial Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Not_yet_recruiting)
• Hematology Hospital of the Chinese Academy of Medical Sciences — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Principal investigator: Lugui Qiu, M.D., Ph.D. — Hematology Hospital of the Chinese Academy of Medical Sciences
• Study coordinator: Yifan Zhai, M.D., Ph.D.

Conditions CLL/SLL; Lisaftoclax; APG-2575