This is a single center, open label, single arm phase II clinical trial. The objective of this study is to assess the feasibility and efficacy of zanubrutinib combined with venetoclax and Rituximab in patients with previously untreated follicular lymphoma (FL) .
A diagnosis of follicular lymphoma (grades 1, 2, or 3a), untreated
Stage II, III, or IV disease
Able and willing to provide written informed consent and to comply with the study protocol
at least one measurable disease
ECOG≤ 2
Absolute neutrophil count (ANC) > 1.0 x 10^9/L
Platelet count > 50 x 10^9/L
Prothrombin time (PT)/international normal ratio (INR) < 1.5 x (upper limit of normal) ULN and partial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) < 1.5 x ULN (unless abnormalities are unrelated to coagulopathy or bleeding disorder). When treated with warfarin or other vitamin K antagonists, then INR ≤ 3.0)
Single group
Zanubrutinib
DrugBTK inhibitor
Rituximab
Biological/VaccineMonoclonal antibody to CD20
Venetoclax
DrugBCL-2 inhibitor
CR rate
Determined by PET/CT based on Cheson, Lugano classification 2014 as assessed by the investigator. The number and percentage of subjects with a CR will be tabulated.
Overall response rate (ORR)
CR + partial response (PR), determined by PET/CT based on Cheson, Lugano classification 2014 as assessed by the investigator. The number and percentage of subjects with an ORR will be tabulated.
Progression-free survival
PFS is defined as the duration from date of treatment initiation to date of disease progression or death from any cause
Overall survival
PFS is defined as the duration from date of treatment initiation to date of death from any cause
Incidence of Treatment-Emergent Adverse Events
Incidence of subjects occuring treatment related adverse events.
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