This is a prospective, single-arm, single-center clinical study. This clinical study aims to explore the efficacy and safety of the ZPR(Zanubrutinib, Polatuzumab vedotin and Rituximab)regimen in the treatment of patients with relapsed and refractory diffuse large B-cell lymphoma.
This is a prospective, single-arm, single-center clinical study. This clinical study aims to explore the efficacy and safety of the ZPR(Zanubrutinib, Polatuzumab vedotin and Rituximab)regimen in the treatment of patients with relapsed and refractory diffuse large B-cell lymphoma. * Primary objective: use ORR to evaluate the effectiveness of ZPR in treating R/R DLBCL patients * Secondary objective: Evaluate the safety of ZPR treatment for R/R DLBCL patients * The subjects received 6 cycles of ZPR regimen, one cycle every 21 days. Then Zanubrutinib alone will continue to be used until Zanubrutinib has been used for 1 year or the disease progresses or the adverse effects, death, withdrawal of informed consent or study termination. Zanubrutinib(Z)160 mg bid po Day 1-21; Polatuzumab vedotin(P)1.8 mg/kg ivgtt D1; Rituximab(R)375 mg/m2 ivgtt D1.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Zanubrutinib(Z)160 mg bid po Day 1-21; Polatuzumab vedotin(P)1.8 mg/kg ivgtt D1; Rituximab(R)375 mg/m2 ivgtt D1
Zhongshan Hospital,Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGORR at the end of the 6th treatment cycle
the proportion of participants who have achieved complete or partial remission determined by the researcher.
Time frame: about six months from the start of ZPR
CRR at the end of the 6th treatment cycle
the proportion of subjects evaluated by researchers to obtain CR.
Time frame: about six months from the start of ZPR
Proportion of patients who have achieved 2-year PFS
Defined as the proportion of participants with a time of ≥ 2 years from the start of treatment to the first recording of disease progression or death, based on the investigator's assessment of the first occurrence
Time frame: 2 years, from the start of treatment to the first recording of disease progression or death, based on the investigator's assessment of the first occurrence
Safety evaluation
incidence and severity of adverse events (AE) and Serious adverse event (SAE) during the study
Time frame: between the first administration of the study drug and 30 days after discontinuation, or during the progression of the disease or the initiation of new anticancer treatment, whichever came first
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