The purpose of this multi-center,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of Chidamide with R-GemOx(rituximab、gemcitabine plus oxaliplatin) regimen in the treatment of transplant-ineligible patients with relapsed/refractory diffuse large B-cell lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
All patients enrolled in the study will accept Chidamide + R-GemOx (Rituximab, Gemcitabine and Oxaliplatin) as their salvage chemotherapy. Patients with CR or PR will receive chidamide maintenance therapy.
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
ORR
the proportion of patients who had CR, and PR according to the revised 2014 Lugano criteria for response assessment of lymphoma.
Time frame: 4-years
DOR
the time from the first CR or PR to the first documented progressive disease (PD) or death, whichever occurred earlier.
Time frame: 4-years
PFS
the time from the date of enrollment until either PD or death.
Time frame: 4-years
OS
the time from the date of enrollment until death
Time frame: 4-years
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