This study evaluates the efficacy and safety of Chidamide plus CHOP regimen for de novo PTCL patients.
After enrollment, patients in this study will be given Chidamide, Cyclophosphamide, Epirubicin, Vincristine and Prednisone, and the efficacy and safety of this regimen are then evaluated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Chidamide is given to the patients in this study along with CHOP regimen, to access the efficacy and safety in this cohort of PTCL patients. The dosage of the above regimen is as follows: Chidamide, 30mg,po,biw; Cyclophosphamide 750mg/m2, ivgtt, d1; Epirubicin 70mg/ m2, ivgtt, d1; Vincristine 3mg/ m2, ivgtt, d1; Prednisone 100mg/ m2, po, d1-5.
the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGComplete Remission Rate
the rate of patients who achieve complete remission after the treatment
Time frame: every 3 months until 30 months after the last patient's enrollment
progression free survival
from date of inclusion to date of progression, relapse, or death from any cause
Time frame: from the day of treatment to the date of first documented progression,up to 30 months after the last patient's enrollment
duration of remission
from date of complete remission to date of progression, relapse, or death from any cause
Time frame: from the day of treatment to the date of first documented progression,up to 30 months after the last patient's enrollment
overall survival
from the date of inclusion to date of death, irrespective of cause
Time frame: 30 months after the last patient's enrollment
adverse events
any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
Time frame: from the date of first cycle of treatment to 30 months after last patient's enrollment
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