A Study of Lisaftoclax (APG-2575) Combined With Acalabrutinib Versus Immunochemotherapy for Newly Diagnosed CLL/SLL.
A Global Multicenter Open Label Randomized Phase III Confirmatory Study of Lisaftoclax (APG-2575) in Combination With Acalabrutinib vs Immunochemotherapy in Patients With Newly Diagnosed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.
1 other identifier
interventional
344
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2024
Typical duration for phase_3
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2024
CompletedFirst Posted
Study publicly available on registry
March 20, 2024
CompletedStudy Start
First participant enrolled
April 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
July 28, 2026
July 1, 2026
3.3 years
March 13, 2024
July 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progress Free Survival (PFS)
PFS is defined as the time from randomization to disease progression(PD) or death from any cause.
Up to 1 year
Secondary Outcomes (3)
Objective Response Rate (ORR)
Up to 1 year
Minimal Residual Disease (MRD) negativity rate
Up to 1 year
Safety evaluation based on the adverse event concurrence
Up to 1 year
Study Arms (2)
Lisaftoclax (APG-2575) combined with Acalabrutinib
EXPERIMENTALLisaftoclax (APG-2575) 600 mg daily plus acalabrutinib 100 mg twice daily for a fixed duration of treatment up to 18 cycles.
Immunochemotherapy regimens
ACTIVE COMPARATORFCR: Fludarabine: intravenously infused at 25 mg/m2 /d on Days 1 to 3 of Cycles 1-6 cyclophosphamide: intravenously infused at 250 mg/m2 /d on Days 1 - 3 of Cycles 1 - 6; rituximab: intravenously infused at 375 mg/m2 on C1D1, and at 500 mg/m2 on Day 1 of Cycles 2 - 6. F or R-Clb: Chlorambucil: orally administrated at 0.5 mg/kg on Days 1 and 15 of Cycles 1-6; rituximab: intravenously infused at 375 mg/m2 on C1D1, and at 500 mg/m2 on Day 1 of Cycles 2 - 6.
Interventions
QD, oral administration, every 28 days for a dosing cycle.
BID, oral administration, every 28 days for a dosing cycle.
Every 28 days for a treatment cycle, administration of 6 cycles.
Every 28 days for a treatment cycle, administration of 6 cycles.
Every 28 days for a treatment cycle, administration of 6 cycles.
Every 28 days for a treatment cycle, administration of 6 cycles.
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
The affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524013, China
Henan Provincial Cancer Hospital
Zhengzhou, Henan, 450003, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430023, China
Hunan Cancer Hospital
Changsha, Hunan, 410031, China
The Second Xiangya Hospital of Center South University
Changsha, Hunan, 545001, China
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, 200065, China
Hematology Hospital of the Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lugui Qiu, M.D., Ph.D.
Hematology Hospital of the Chinese Academy of Medical Sciences
- PRINCIPAL INVESTIGATOR
Keshu Zhou, M.D., Ph.D.
Henan Province Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2024
First Posted
March 20, 2024
Study Start
April 7, 2024
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2028
Last Updated
July 28, 2026
Record last verified: 2026-07