This study aim to evaluate the efficacy and safety of zanubrutinib combined with R-CHOP in the treatment of DLBCL patients with p53 protein expression.
This is a prospective, single arm, single center study,it plans to recruit 41 newly diagnosed DLBCL patients with p53 protein expression(≥50%).According to Simon's two-stage optimal design criteria, 19 eligible patients were recruited in the first phase, and at least 12 patients were required to achieve complete response to enter the second phase. In phase 2, additional 22 patients were recruited. These patients will receive zanubrutinib plus RCHOP for 6 cycles. After 4 treatment cycles, an interim response assessment will be performed to evaluate disease progression for each participant. Participants with progressive or stable disease will be discontinued from treatment,Participants with complete/partial response will continue ZRCHOP until 6 cycles are completed.After completion of study drug, participants will undergo assessment of tumor response based on the Revised Response Criteria for Malignant Lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Rituximab 375mg/m2 D1; cyclophosphamide 750mg/m2 D2; adriamycin 50 mg/m2 D2 vincristine 1.4mg/m(Max 2mg) D2; prednisone 100mg/d D2-6; Zanubrutinib 160 mg, the bid D1-21
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGComplete response rate (CRR)
To evaluate the efficacy of anti-lymphoma
Time frame: At the end of cycle 6 (each cycle is 21 days )
Overall response rate (ORR)
To evaluate the efficacy of anti-lymphoma
Time frame: At the end of cycle 6 (each cycle is 21 days )
Progression-free survival (PFS)
To evaluate the efficacy of anti-lymphoma
Time frame: From date of initiation therapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Overall survival (OS)
To evaluate the efficacy of anti-lymphoma
Time frame: From date of initiation therapy until the date of death from any cause, assessed up to 60 months
Rate of AE and SAE
To identify the incidence of AE and SAE in clinical trial
Time frame: from the initiation of the first dose to 28 days after the last dose
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