Actively Recruiting
A Global Study of Lisaftoclax (APG-2575) Combined With Acalabrutinib Versus Immunochemotherapy for Newly Diagnosed CLL/SLL.
Led by Ascentage Pharma Group Inc. · Updated on 2024-05-29
344
Participants Needed
6
Research Sites
225 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 according to IWCLL NCI-WG Guidelines (2018) and meets criteria for treatment
- Measurable disease present
- ECOG performance status score between 0 and 2
- QTcF interval 6450ms in males and 6470ms in females
- Adequate bone marrow function without growth factor support
- Adequate liver, kidney, and blood clotting function
- Males and females of childbearing potential must use effective contraception during treatment and for 3 months after last dose; male patients must avoid sperm donation from first dose to 3 months after last dose
- Female patients of childbearing potential must have a negative pregnancy test within 14 days before first dose
- Ability and willingness to understand and voluntarily sign informed consent
- Willingness and ability to complete study procedures and follow-up exams
You will not qualify if you...
- Previous treatment specifically for CLL
- Incomplete recovery from recent surgery: major surgery within 28 days or minor surgery (except biopsy) within 14 days before first dose
- Significant cardiovascular disease within 6 months before study entry
- History of serious kidney, neurological, psychiatric, lung, endocrine, metabolic, immune, heart, or liver disease that may affect participation
- Need for warfarin or other anticoagulants or active bleeding within 2 months before study
- Known allergy to study drugs or similar compounds
- Pregnant or breastfeeding, or planning pregnancy during study or within 3 months after last dose
- Other active cancer within 3 years before study entry except CLL/SLL
- Malabsorption syndrome or conditions unsuitable for oral drug intake
- Other uncontrolled significant symptoms
- Primary active autoimmune or connective tissue diseases
- Any other condition making participation unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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.
CONTACT
B
Bo Huang, M.D.
CONTACT
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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