Combining Lisaftoclax and Acalabrutinib for Newly Diagnosed CLL/SLL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Guangdong Provincial People's Hospital
  Guangzhou, Guangdong, China Recruiting
• Nanfang Hospital of Southern Medical University
  Guangzhou, Guangdong, China Recruiting
• Henan Provincial Cancer Hospital
  Zhengzhou, Henan, China Recruiting
• Hematology Hospital of the Chinese Academy of Medical Sciences
  Tianjin, Tianjin Municipality, China Recruiting
• The First Affiliated Hospital of Bengbu Medical College
  Bengbu, Anhui, China Not yet recruiting
• The affiliated Hospital of Guangdong Medical University
  Zhanjiang, Guangdong, China Not yet recruiting

Study contacts

• Principal investigator: Lugui Qiu, M.D., Ph.D. — Hematology Hospital of the Chinese Academy of Medical Sciences
• Study coordinator: Miguel Rosado-Cadena, MD
• Email: miguel.cadena@ascentage.com
• Phone: +1 301-532-7085

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Retreatment with venetoclax and acalabrutinib for relapsed CLL

  This study is testing if a new combination of venetoclax and acalabrutinib can help people with relapsed chronic lymphocytic leukemia (CLL) achieve better treatment results after their previous therapy.

  Recruiting at 18 sites Phase 2 Stichting Hemato-Oncologie voor Volwassenen Nederland · Brussels and 17 other locations · NCT04523428

• Tafasitamab plus Acalabrutinib and Venetoclax for newly treated CLL/SLL

  This phase II study tests a combination of tafasitamab, acalabrutinib, and venetoclax in adults who are newly diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma to see if it is safe and effective.

  Recruiting at 2 sites Phase 2 City of Hope Medical Center · Duarte, California and 1 other locations · NCT07582159

• Acalabrutinib for CLL in routine care in Belarus

  This project will see how well acalabrutinib works and how safe it is for adults with chronic lymphocytic leukemia treated in routine clinical practice in Belarus.

  Recruiting at 3 sites AstraZeneca · Grodno and 3 other locations · NCT07288515

• Sonrotoclax plus zanubrutinib versus venetoclax plus acalabrutinib for adults with untreated CLL

  This tests whether a fixed-duration combination of sonrotoclax plus zanubrutinib works as well as or better than venetoclax plus acalabrutinib for adults with previously untreated CLL who need treatment.

  Recruiting at 114 sites Phase 3 BeOne Medicines · Duarte, California and 114 other locations · NCT07277231

• Epcoritamab given after 2nd-generation BTK inhibitors for CLL/SLL

  This trial will try giving subcutaneous epcoritamab for up to 12 cycles to adults with CLL/SLL who have been on a second‑generation BTK inhibitor for at least 12 months to see if it can deepen responses to a complete remission with undetectable MRD so therapy can be stopped.

  Recruiting Phase 2 University of Cincinnati · Cincinnati, Ohio · NCT07108998

• Acalabrutinib plus R-CHOP as first-line treatment for mantle cell lymphoma in Spain

  This test will see if adding acalabrutinib to standard R-CHOP helps adults in Spain with newly diagnosed mantle cell lymphoma.

  Recruiting at 21 sites Phase 2 AstraZeneca · A Coruña and 21 other locations · NCT07029737

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.