This study aims to investigate the treatment of refractory or relapsed DLBCL with orelabrutinib and gemox. The primary endpoint is response rate (complete response rate and overall response rate), and the second endpoints are survival time (OS and PFS) and toxicities.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
77
Drug: Orelabrutinib Orelabrutinib 200mg, po, qd Drug: Gemox14 Gemcitabine, Oxaliplatin
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Guangxi Medical University Cancer Hospital
Naning, Guangxi, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Overall response rate
overall response rate after treated by Orelabrutin and Gemox
Time frame: 12 weeks after the initiation of the treatment
Progression Free Survival (PFS)
PFS was defined as time from study registration to first disease progression or death whichever occurred first, otherwise subject data were censored at time last known disease free
Time frame: Up to two years after the start of the study
Overall Survival (OS)
OS was defined as time from study registration to death, and otherwise censored at time last known alive
Time frame: Up to two years after the start of the study
Duration of Response(DOR)
The time from the first assessment of CR or PR to PD (progressive disease) or death from any cause
Time frame: Up to three years after the start of the study
Adverse events
All the adverse events of the patients related will be assessed and graded by NCI CTCAE v5.0
Time frame: Up to one year after the start of the study
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West China Hospital.Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China