Actively Recruiting
A Global Study of Lisaftoclax (APG-2575) Combined With Acalabrutinib Versus Immunochemotherapy in Patients With Newly Diagnosed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Led by Ascentage Pharma Group Inc. · Updated on 2024-05-29
344
Participants Needed
6
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of Lisaftoclax (APG-2575) combined with Acalabrutinib compared to immunochemotherapy in patients newly diagnosed with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL). This global, multicenter, randomized, open-label Phase III study aims to confirm whether this combination treatment provides benefits over standard immunochemotherapy regimens. The trial is sponsored by Ascentage Pharma Group Inc. and follows guidelines for diagnosis and treatment need according to IWCLL NCI-WG (2018 edition). Participants will be randomly assigned to receive either the experimental treatment—Lisaftoclax taken orally once daily and Acalabrutinib taken orally twice daily in 28-day cycles—or standard immunochemotherapy involving drugs such as Fludarabine, Cyclophosphamide, Rituximab, or Chlorambucil administered every 28 days for six cycles. Treatment duration, dosing schedules, and combinations are carefully monitored throughout the study period. During the study, patients will undergo assessments including measuring progression-free survival up to one year, evaluating response rates, and checking minimal residual disease negativity. Safety will be monitored by recording adverse events during the same period. Participants must complete research procedures and follow-up exams, with the study expected to continue until August 2028. Informed consent and adherence to study procedures are required for all participants.
CONDITIONS
Brief Title
A Global 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 following IWCLL NCI-WG Guidelines (2018 edition) and requiring treatment
- Measurable disease present
- ECOG performance score between 0 and 2
- QTcF interval ≤450ms for males and ≤470ms for females
- Adequate bone marrow function without growth factor support
- Adequate liver, kidney, and blood clotting function
- Males and females of childbearing potential and their partners agree to use effective contraception during treatment and for 3 months after
- Female patients of childbearing potential have negative pregnancy test within 14 days before first dose
- Able to understand and voluntarily sign informed consent
- Willing and able to complete study procedures and follow-up examinations
You will not qualify if you...
- Any previous treatment for CLL
- 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 prior to study entry
- History of serious kidney, neurological, psychiatric, lung, endocrine, metabolic, immune, cardiovascular, or liver disease that may affect participation
- Use of warfarin or other anticoagulants or active bleeding within 2 months before study start
- Known allergy to study drugs or their ingredients
- Pregnant or breastfeeding, or planning pregnancy during the study or within 3 months after last dose
- History of other active cancer within 3 years except CLL/SLL
- Malabsorption syndrome or conditions unsuitable for oral drug administration
- Other significant uncontrolled symptoms
- Primary active autoimmune or connective tissue diseases
- Any other condition deemed unsuitable for participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 cycles of 28 days each
Participants receive either Lisaftoclax combined with Acalabrutinib or immunochemotherapy regimens as treatment for CLL/SLL.
Visits every 28 days for treatment cycles
Duration - Up to 1 year
Participants are monitored for disease progression, treatment response, and safety outcomes after treatment completion.
Regular follow-up visits during the year after treatment
Trial Site Locations
Total: 6 locations
1
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China, 233004
Not Yet Recruiting
2
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Not Yet Recruiting
3
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510515
Not Yet Recruiting
4
Henan Provincial Cancer Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
5
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430023
Not Yet Recruiting
6
Hematology Hospital of the Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
Y
Yifan Zhai, M.D., Ph.D.
B
Bo Huang, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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