This is a prospective, multicenter, phase III study of Tucidinostat, Azacitidine combined with CHOP versus CHOP in patients with untreated peripheral T-cell lymphoma
Tucidinostat, a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China. Azacytidine is a hypomethylating agent. The aim of this study is to compare the efficacy and safety of azacytidine, tucidinostat combined with CHOP regimen and classical CHOP regimen in the treatment of primary PTCL
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
107
Azacitidine: 200 mg D1200 mg D2100 mg D3 subcutaneous injection Tucidinostat: 20mg / time, D1, 4, 8, 11; Take medicine with 200ml warm boiled water 30 minutes after breakfast. CHOP chemotherapy: * Cyclophosphamide (CTX) 750mg / m2 intravenous infusion, day 1; * Epirubicin (EPI) 70mg / m2 intravenous infusion, day 1; * Vinoresin (VDS) 4mg intravenous infusion, day 1; * Prednisone 100mg orally, day 1-5. Every 21 days is a course of treatment
Peking Union Medical College Hospital
Beijing, China
RECRUITINGOverall response rate (ORR)
the total proportion of patients with complete response (CR) and partial response (PR)
Time frame: 6 course of treatment (each cycle is 21 days)
2-year progression-free survival(PFS)
Time from treatment until disease progression or death
Time frame: 2 years
2-year overall survival(OS)
Time from treatment until death from any cause
Time frame: 2 years
Incidence and severity of adverse events, serious adverse events and other safety parameters
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0
Time frame: 2 years
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