A Randomised, Double-blind, Multicenter Phase Ⅲ Study to Evaluate the Efficacy and Safety of Tucidinostat versus Placebo in Combination with CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma with Follicular Helper of T Cell Phenotype
This is A Randomised, Double-blind, Multicenter Phase Ⅲ Study to Evaluate the Efficacy and Safety of Tucidinostat versus Placebo in Combination with CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma with Follicular Helper of T Cell Phenotype.Participants Will be Randomised (1:1) to ReceiveTucidinostat (Experimental Arm) or Placebo(Control Arm)in Combination with CHOP .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
224
Cyclophosphamide 750 mg/m2 , intravenous infusion on day 1 of each 21-day cycle. Doxorubicin 70mg/m2 , intravenous infusion on day 1 of each 21-day cycle, total 6 cycles. Vincristine 1.4mg/m2(Max dose 2mg), intravenous injection on day 1 of each 21-day cycle , total 6 cycles. Prednisone 100 mg, oral, day 1-5 of each 21-day cycle,total 6 cycles.
oral, taking as prescribed by the protocol
oral, taking as prescribed by the protocol
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGProgression-Free Survival (PFS)
Defined as the duration from the date of randomization to the date of progression, relapse from CR, or death, whichever occurred first.
Time frame: Up to approximately 60 month
Complete Response Rate(CRR)
Time frame: Up to approximately 36 months
Overall response rate (ORR)
Defined as the proportion of subjects with measurable disease who achieve CR or partial response (PR)
Time frame: Up to approximately 36months
Event Free Survival (EFS)
Defined as the duration from the date of randomization to the date of disease progression, initiation of subsequent systemic antilymphoma therapy for residual disease, or death, whichever occurs first.
Time frame: Up to approximately 60 month
Disease-Free Survival (DFS)
Defined for participants achieving CR as the period from the date of the initial CR until the date of relapse or death from any cause.
Time frame: Up to approximately 60 month
Overall Survival (OS)
defined as the duration from the date of randomization to the date of the participant's death
Time frame: Up to approximately 60 month
Safety and Tolerability
Number of Participants Who Experience an Adverse Event (AE) assessed by CTCAE v5.0.
Time frame: Up to approximately 78 months
Plasma concentrations of tucidinostat
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Plasma samples were collected from the participants at the defined time points. Plasma concentrations were measured using a validated, specific, and sensitive method.
Time frame: Up to approximately 60 month