This is a multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with R-CHOP in the treatment of treatment-naïve patients with double expression DLBCL.
The patients will be treated with 6/8 cycles of orelabrutinib plus R-CHOP regimen（21 days per cycle). The primary objective was the complete response rate (CRR) at end of induction therapy
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Orelabrutinib 150mg qd PO. Rituximab 375 mg/m2 IV on Day 0 of each 21-day cycle. The CHOP include cyclophosphamide, doxorubicin/Epirubicin/liposomal doxorubicin, vincristine/Vindesine, and prednison.
The First Ailliated Hospital of Nanchang University
Nanchang, Jiangxi, China
RECRUITINGShandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Jinan, Shandong, China
RECRUITINGcomplete response rate
Time frame: up to 24 weeks
ORR
ORR is defined as the proportion of patients with a best response of CR or PR
Time frame: up to 24 weeks
2 years progression-free survival
2 years progression-free survival was calculated from the date of therapy until death from lymphoma or 2-year follow-up without relapsing
Time frame: From date of receiving the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years]
2 years overall survival
2 years overall survival was calculated from the date of therapy until death from lymphoma or 2-year follow-up alive
Time frame: From date of receiving the first dose until the date of death from any cause,assessed up to 2 years
The occurrence of adverse events and serious adverse events
Adverse events will be graded by the investigator according to the NCI-CTCAE Version 5.0.
Time frame: up to 30 months
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