Actively Recruiting
Global Phase III Trial Evaluating Lisaftoclax Plus Acalabrutinib Compared to Immunochemotherapy in Newly Diagnosed CLLSLL Patients
Led by Ascentage Pharma Group Inc. · Updated on 2026-07-28
344
Participants Needed
10
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of Lisaftoclax APG-2575 and Acalabrutinib compared to immunochemotherapy for patients newly diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma CLLSLL. This global, multicenter, Phase III study aims to confirm the efficacy and safety of this combination treatment in patients who meet specific clinical criteria, including measurable disease and an ECOG score between 0 and 2. Participants will be randomly assigned to receive either the investigational treatment of Lisaftoclax 600 mg daily plus Acalabrutinib 100 mg twice daily for up to 18 treatment cycles or one of two immunochemotherapy regimens involving drugs such as fludarabine, cyclophosphamide, rituximab, or chlorambucil over six cycles. Both treatments are administered mostly by oral or intravenous routes following fixed dosing schedules. Throughout the study, participants will undergo regular assessments to monitor progression-free survival, response rates, minimal residual disease negativity, and safety over one year. Evaluations include physical exams, laboratory tests, and adverse event monitoring. Participants must be able to consent, complete study procedures, and will be followed for treatment outcomes and safety, with the trial expected to complete by August 2028.
CONDITIONS
Brief Title
A Study of Lisaftoclax (APG-2575) Combined With Acalabrutinib Versus Immunochemotherapy for Newly Diagnosed CLL/SLL.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with CLL/SLL according to IWCLL NCI-WG Guidelines (2018) and meet treatment criteria
- Measurable disease present
- ECOG performance status score between 0 and 2
- QTcF interval ≤450 ms in males, ≤470 ms in females
- Adequate bone marrow function without growth factor support
- Adequate liver, kidney, and blood clotting function
- Use of effective contraception by males and females of childbearing potential during treatment and for 3 months after last dose
- Negative pregnancy test within 14 days before first dose for females of childbearing potential
- Ability to understand and voluntarily sign informed consent
- Willingness and ability to complete study procedures and follow-up
You will not qualify if you...
- Prior CLL-specific treatment
- Incomplete recovery from recent surgery: major surgery within 28 days or minor surgery within 14 days before first dose
- Significant cardiovascular disease within 6 months before study entry
- History of serious kidney, neurological, psychiatric, pulmonary, endocrine, metabolic, immune, cardiovascular, or liver disease affecting study participation
- Requirement for warfarin or other anticoagulants or active bleeding within 2 months before study entry
- Known allergy to study drugs or similar compounds
- Pregnant or breastfeeding, or planning pregnancy during study or 3 months after last dose
- Other active malignancies within 3 years before study entry except CLL/SLL
- Malabsorption or conditions unsuitable for oral medication
- Uncontrolled significant symptoms
- Primary active autoimmune or connective tissue diseases
- Any other conditions making the patient unsuitable as judged by the investigator
Research Team
M
Miguel Rosado-Cadena, MD
J
Jocelyn Budzynski
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