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.
CLL/SLL must be diagnosed according to the IWCLL NCI-WG Guidelines (2018 edition) and meet at least one of the criteria requiring treatment.
With a measurable disease.
ECOG score 0-2.
QTcF interval: ≤450ms in males, ≤470ms in females.
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.
Parallel
Lisaftoclax (APG-2575)
DrugQD, oral administration, every 28 days for a dosing cycle.
Acalabrutinib
DrugBID, oral administration, every 28 days for a dosing cycle.
Fludarabine
DrugEvery 28 days for a treatment cycle, administration of 6 cycles.
Cyclophosphamide，CTX
DrugEvery 28 days for a treatment cycle, administration of 6 cycles.
Rituximab
DrugEvery 28 days for a treatment cycle, administration of 6 cycles.
Chlorambucil
DrugEvery 28 days for a treatment cycle, administration of 6 cycles.
Progress Free Survival (PFS)
PFS is defined as the time from randomization to disease progression(PD) or death from any cause.
Objective Response Rate (ORR)
ORR is defined as the proportion of patients who have achieved CR, CRi or PR.
Minimal Residual Disease (MRD) negativity rate
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
Number of treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs) will be evaluated.
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