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
Voluntarily participate in the clinical study; fully understand and be informed about the study and sign the Informed Consent Form (ICF); willing to comply with and capable of completing all trial procedures;
Diagnosed with PTCL according to the 2022 revised WHO lymphoma classification standards based on pathological diagnosis by the research center
Using the Lugano 2014 lymphoma efficacy evaluation criteria, the patient must have at least one measurable or evaluable lesion
Treatment failure to at least one prior line of systemic standard therapy for PTCL.
Accompanied by hemophagocytic lymphohistiocytosis (HLH)
Lymphoma involvement in the central nervous system or meninges
Active infections
Uncontrolled clinical cardiac symptoms or diseases
Single group
Linperlisib
DrugLinperlisib: 80 mg or 60 mg, po, qd (phase Ib); RP2D (phase II)
Chidamide
DrugChidamide: 20mg, po, biw
Dose-limiting toxicity (DLT) for Phase 1b
To identify the DLT
Overall response rate(ORR) for Phase 2
The proportion of patients who achieve complete remission (CR) or partial remission (PR) as the best response.
Complete response rate (CRR)
Defined as the proportion of patients who achieve complete remission as the best response
Duration of Response(DOR)
To investigate the preliminary anti-tumor efficacy
Progression-free survival(PFS)
To investigate the preliminary anti-tumor efficacy
Overall survival(OS)
To investigate the preliminary anti-tumor efficacy
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This trial is not recruiting at the moment. You can still explore other options:
