Aim of this study will evaluate the efficacy and safety of Polatuzumab Vedotin and Zanubrutinib in combination with R-CHP for newly diagnosed untreated Non-GCB DLBCL Patients with extranodal involvement.
Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin's lymphoma. According to Hans' algorithms, DLBCL can be identified as 2 subtypes: germinal b-cell-like(GCB) and non-germinal b-cell-like(non-GCB). Approximately 50 to 60% of DLBCL was non-GCB subtype DLBCL.The non-GCB DLBCL revealed poor clinical outcomes. Bruton's tyrosine kinase (BTK) inhibitors have established therapeutic activity in B cell malignancies, with potential activity in non-GCB DLBCL. The POLARIX study also observed an benefit in the efficacy of Polatuzumab Vedotin in first-line treatment of DLBCL patients. This study will evaluate the efficacy and safety of Polatuzumab Vedotin and Zanubrutinib in combination with R-CHP for newly diagnosed untreated Non-GCB DLBCL Patients with extranodal involvement.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
1.8mg/kg/21d(d0) Intravenous infusion
160mg bid PO(d0-d20)
375mg/㎡/21d(d0) Intravenous infusion
The First Affiliated Hospital of Soochow University
Suzhou, Nanjing, China
Progression-free Survival(PFS)
The time between enrollment and tumor occurrence (in any aspect) progression or (for any reason) death
Time frame: From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.
Objective Response rate(ORR)
The proportion of patients who achieved complete or partial response in efficacy evaluation at the end of treatment
Time frame: From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.
Complete Response(CR)
The proportion of patients who achieved complete response in efficacy evaluation at the end of treatment
Time frame: From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.
Duration of Response(DOR)
It refers to the time from the first assessment of a tumor as CR or PR to the second assessment as PD (Progressive Disease) or death from any cause.
Time frame: All time in the study
Overall Survival
The time between enrollment to death(for any reason) .
Time frame: From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.
Adverse Events(AEs)
All treatment-related adverse events that occur during patient treatment and follow-up.
Time frame: From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.
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750mg/㎡/21d(d1) Intravenous infusion
50mg/㎡/21d(d1) Intravenous infusion
100mg PO (d1-d5)/21d