This study is a prospective, open-label, single-arm phase II clinical study to evaluate the safety and efficacy of zanubrutinib plus R-CHOP (ZR-CHOP) as the first-line therapy for newly diagnosed diffuse large B-cell lymphoma patients with high-risk factors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Zanubrutinib 160mg bid p.o d0-d20(21-day cycles)
Rituximab 375 mg/m2 i.v d0(21-day cycles)
Cyclophosphamide 750 mg/m2 i.v d1(21-day cycles)
Xing Xiaojing
Shenyang, Liaoning, China
Complete response rate(CRR)
Time frame: Up to approximately 2.5 years
Overall response rate (ORR)
Time frame: Up to approximately 2.5 years
Progression-free Survival(PFS)
Time frame: Up to approximately 2.5 years
Overall survival (OS)
Time frame: Up to approximately 2.5 years
Duration of Response
Time frame: At 2 years
Incidence of adverse event
Time frame: At 2 years
Assessment of the correlation between MYD88、CD79B、NOTCH1、BCL6、NOTCH2 or other gene abnormality and efficacy.
Time frame: At 2 years
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Epirubicin 75 mg/m2 i.v d1 or liposome adriamycin 35mg/m2 i.v d1(21-day cycles)
Vincristine 1.4 mg/m2 i.v d1 (2 mg max) (21-day cycles)
Prednisone 100 mg p.o d1-d5 (21-day cycles)