The purpose of this study is to investigate efficacy and safety of Chidamide Combined With Cyclophosphamide,Prednisone,Thalidomide in Treatment of Fragile Patients With Relapse/Refratory Peripheral T Cell Lymphoma :a Phase II,Single-arm,Open-label, Muti-center Study
Chidamide is a new histone deacetylase inhibitor and shows anti-tumor activity in Relapse/Refratory Peripheral T Cell Lymphoma.Cyclophosphamide,Prednisone,Thalidomide(CPT) is an oral combination regimen for lymphoma patients who can not stand the standard chemotherapy. The investigators therefore design this open-label,phase II, single-arm trial to investigate the efficacy of Chidamide Combined With CPT in treatment of fragile Patients With Relapse/Refratory Peripheral T Cell Lymphoma Primary Outcome Measures: • overall response rate Secondary Outcome Measures: * duration of response * progression free survival * overall survival Enrollment:45 Study Start Date: August 2016 Primary Completion Date: March 2018
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Chidamide 30mg ,twice a week Prednisone 20mg qd Cyclophosphamide 50mg qd Thalidomide 100mg qd
HuaiAn First People's Hospital
HuaiAn, Jiangsu, China
RECRUITINGWuXi People's Hospital
Wuxi, Jiangsu, China
RECRUITINGOverall response rate (ORR)
overall response rate after treated by C-CPT
Time frame: One-year
Duration of response
from the date of response to date of progression, relapse,
Time frame: One-year
Progress-free survival
from date of inclusion to date of progression, relapse, or death from any cause
Time frame: One-year
Overall survival
from the date of inclusion to date of death, irrespective of cause
Time frame: One-year
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