Chidamide With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide for Peripheral T Cell Lymphoma Patients : a Prospective, Randomized Controlled, Open Label, Phase II Clinical Trial
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 With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide for Peripheral T Cell Lymphoma Patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
114
Chidamide 15mg orally BIW. Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
Cyclophosphamide(750mg/m2) was administered intravenously on d1. Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
Doxorubicin (50mg/m2)was administered intravenously on d1.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
Beijing Cancer Hospital
Beijing, China
RECRUITINGcomplete remission (CR)rate
The rate of patients who achieve complete remission after the treatment.
Time frame: up to 2 years
objective response rate(ORR)
The total proportion of patients with complete response(CR)and partial response(PR).
Time frame: up to 2 years
progression-free survival(PFS)
Time from treatment until disease progression or death.
Time frame: 2 years
overall survival(OS)
From the date of inclusion to date of death, irrespective of any cause.
Time frame: 2 years after the last patient's enrollment.
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Vincristine (1.4mg)was administered intravenously on d1.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
Etoposide (100mg/m2) was administered intravenously on d1,2,3.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
Prednisone (100mg)was administered by oral on d1-5.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.