This is a prospective, multicenter, open-label, phase Ib/II clinical study to evaluate the safety and efficacy of linperlisib combined with chidamide in the treatment of relapsed or refractory peripheral T-cell lymphoma
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Linperlisib: 80 mg or 60 mg, po, qd (phase Ib); RP2D (phase II)
Chidamide: 20mg, po, biw
Dose-limiting toxicity (DLT) for Phase 1b
To identify the DLT
Time frame: The first cycle (each cycle is 28 days) after administration
Overall response rate(ORR) for Phase 2
The proportion of patients who achieve complete remission (CR) or partial remission (PR) as the best response.
Time frame: Up to 24 months
Complete response rate (CRR)
Defined as the proportion of patients who achieve complete remission as the best response
Time frame: Up to 24 months
Duration of Response(DOR)
To investigate the preliminary anti-tumor efficacy
Time frame: Up to 4 years
Progression-free survival(PFS)
To investigate the preliminary anti-tumor efficacy
Time frame: Up to 4 years
Overall survival(OS)
To investigate the preliminary anti-tumor efficacy
Time frame: Up to 4 years
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