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) .
Follicular lymphoma (FL)is the most common inert non Hodgkin's lymphoma (iNHL). Their natural courses are slow but highly variable. The standard first-line treatment of advanced FL is based on rituximab. Whether combined with chemotherapy or not, it can induce lasting remission, but it is usually incurable. Although the first-line immunochemotherapy regimen has high efficacy, it also has high toxicity. Cytotoxic chemotherapy is related to many side effects, including bone marrow suppression and immunosuppression, gastrointestinal and cardiac toxicity, neurotoxicity and the occurrence of secondary tumors. About 20% of FL patients relapse within 2 years after first-line chemotherapy. The overall prognosis of these patients is poor. This clinical trial aims to evaluate the feasibility and efficacy of free-chemotherapy regimen (zanubrutinib combined with venetoclax and Rituximab) in patients with previously untreated follicular lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
BTK inhibitor
Monoclonal antibody to CD20
BCL-2 inhibitor
Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital
Beijing, China
RECRUITINGCR 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.
Time frame: Within 6 months of therapy completion
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.
Time frame: Within 6 months of therapy completion
Progression-free survival
PFS is defined as the duration from date of treatment initiation to date of disease progression or death from any cause
Time frame: up to two years
Overall survival
PFS is defined as the duration from date of treatment initiation to date of death from any cause
Time frame: up to two years
Incidence of Treatment-Emergent Adverse Events
Incidence of subjects occuring treatment related adverse events.
Time frame: Up to 90 days after the last dose of study drugs
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