A Global Study of Lisaftoclax (APG-2575) Combined With Acalabrutinib Versus Immunochemotherapy for Newly Diagnosed CLL/SLL.
- Conditions
- CLL/SLL
- Interventions
- Drug: Cyclophosphamide，CTX
- Registration Number
- NCT06319456
- Lead Sponsor
- Ascentage Pharma Group Inc.
- Brief Summary
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.
- Detailed Description
The patients with newly diagnosed CLL/SLL, who have met all required eligibility criteria, will be randomized to the investigational group (Lisaftoclax in combination with Acalabrutinib) or the control group (immunochemotherapy, CIT).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 344
Not provided
- Any previous CLL specific treatment.
- 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.
- Presence of significant cardiovascular disease within 6 months prior to study entry.
- 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.
- Patients who require warfarin or other anticoagulants or active hemorrhage occur within 2 months before study entry.
- Known to have hypersensitivity to the drug ingredient or its analogues.
- 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.
- Patients who have history of other active malignant tumor other than CLL/SLL within 3 years before study entry.
- With a malabsorption syndrome or other conditions unsuitable for enteral administration.
- Other clinically significant uncontrolled symptoms.
- With primary active autoimmune disease and connective tissue disease.
- Any other circumstances or conditions that would, at the discretion of the investigator, make the patient unsuitable for the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lisaftoclax (APG-2575) combined with Acalabrutinib Lisaftoclax (APG-2575) - Immunochemotherapy regimens Cyclophosphamide，CTX - Immunochemotherapy regimens Fludarabine - Lisaftoclax (APG-2575) combined with Acalabrutinib Acalabrutinib - Immunochemotherapy regimens Chlorambucil - Immunochemotherapy regimens Rituximab -
- Primary Outcome Measures
Name Time Method Progress Free Survival (PFS) Up to 1 year PFS is defined as the time from randomization to disease progression(PD) or death from any cause.
- Secondary Outcome Measures
Name Time Method Minimal Residual Disease (MRD) negativity rate Up to 1 year To observe the proportion of patients with MRD negativity in bone marrow, peripheral blood, either or both.
Safety evaluation based on the adverse event concurrence Up to 1 year Number of treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs) will be evaluated.
Objective Response Rate (ORR) Up to 1 year ORR is defined as the proportion of patients who have achieved CR, CRi or PR.
Trial Locations
- Locations (6)
Henan Provincial Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Hematology Hospital of the Chinese Academy of Medical Sciences
🇨🇳Tianjin, Tianjin, China
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China