This is a prospective phase II clinical trial to observe the efficacy and safety of Chidamide combined with DICE (Dexamethasone, Ifosfamide, Cisplatin and Etoposide) in patients with relapsed or refractory B-cell Non-Hodgkin's Lymphoma (NHL).
Chidamide,a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China. The aim of this study was to observe the efficacy and safety of Chidamide combined with DICE in patients with relapsed or refractory B-cell Non-Hodgkin's Lymphoma (NHL).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Chidamide 20mg orally d1, 4, 8, 11, 15, 18; Dexamethasone 10mg,ivg, d1-4; ifosfamide 1g/m2, ivg, d1-4, given over 4 hours; Mesna 0.4g, 0,4,8,12 hours during Ifosfamide transfusion, ivg, d1-4; Cisplatin 25mg/m2, ivg, d1-4; Etoposide 60mg/m2, ivg. d1-4.
objective response rate(ORR)
the total proportion of patients with complete response(CR or CRu)and partial response(PR)
Time frame: every 6 weeks until 2 years
progression-free survival(PFS)
Time from treatment until disease progression or death
Time frame: 2 years
events-free survival(EFS)
Time from treatment to disease progression, death, or discontinuation of treatment for any reason
Time frame: 2 years
overall survival(OS)
Time from treatment until death from any cause
Time frame: 2 years
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