This study is a multicenter, single-arm, non-randomized, open-label trial designed to evaluate the efficacy and safety of chidamide and azacitidine in combination with prednisone, cyclophosphamide, and thalidomide (CAPCT regimen) in patients with peripheral T-cell lymphoma (PTCL). A total of 58 patients with PTCL are planned to be enrolled after providing written informed consent and meeting all eligibility criteria. Enrolled patients will receive the CAPCT regimen, with each cycle consisting of 21 days, for a total of 6 cycles. Participants who do not experience disease progression or unacceptable toxicity after 6 cycles of combination therapy will continue to receive the CPCT regimen (chidamide combined with prednisone, cyclophosphamide, and thalidomide) for up to 6 months, followed by chidamide monotherapy as maintenance treatment. The primary efficacy endpoint is objective response rate (ORR).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Chidamide tablets,:Oral administration at a dose of 20 mg (4 tablets) per intake, twice weekly, with an interval of no less than 3 days between the two doses .
Subcutaneous injection at a dose of 100 mg/day on Days 1-7
Oral administration at a dose of 20 mg/day, taken after breakfast.
Oral administration at a dose of 50 mg/day, taken after lunch.
Oral administration at a dose of 100 mg/day, taken before bedtime.
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Objective Response Rate(ORR)
The proportion of patients who achieve a CR 、CRu and PR
Time frame: Up to 2 years
Duration of Response(DoR)
The time from the first documented objective response (CR or PR) to the first documented disease progression or death from any cause.
Time frame: Up to 2 years
Progression-Free Survival(PFS)
The time from the start of treatment to the first documented disease progression or death from any cause, whichever occurs first.
Time frame: From treatment to the end of treatment at 12months
Overall Survival(OS)
The time from the start of treatment to death from any cause.
Time frame: From treatment to the end of treatment at 24 months
Adverse Event
AEs
Time frame: From enrollment to the end of treatment at 24 months
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