Linperlisib Combined With Chidamide in the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma

Not Applicable

Not yet recruiting

• Conditions: Peripheral T Cells Lymphoma (PTCL)
• Interventions: Drug: Linperlisib; Drug: Chidamide

• Registration Number: NCT07139353
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-15
• Study First Submitted QC: 2025-08-21
• Last Update Submitted: 2025-08-21
• Study First Posted: 2025-08-24
• Last Update Posted: 2025-08-24
• Study Start: 2025-09-15
• Primary Completion: 2027-09-01
• Study Completion: 2029-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• 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.
• Age ≥ 18 years
• Expected survival greater than 12 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Adequate organ and bone marrow function

Exclusion Criteria

• Accompanied by hemophagocytic lymphohistiocytosis (HLH)
• Lymphoma involvement in the central nervous system or meninges
• Active infections
• Uncontrolled clinical cardiac symptoms or diseases
• Currently using (or unable to stop at least one week prior to the first dose) a known CYP3A strong inducer or strong inhibitor.
• Currently using vitamin K antagonists, antiplatelet drugs, anticoagulants (or unable to stop them within one week prior to the start of the study treatment).
• History of Human Immunodeficiency Virus (HIV) infection and/or Acquired Immunodeficiency Syndrome (AIDS).
• Patients with mental disorders or those unable to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Linperlisib Combined with Chidamide	Linperlisib	Patients will receive Chidamide 20 mg orally twice weekly (biw) in combination with Linperlisib at the RP2D (80 mg or 60 mg, po, qd). Each treatment cycle is 28 days.
Linperlisib Combined with Chidamide	Chidamide	Patients will receive Chidamide 20 mg orally twice weekly (biw) in combination with Linperlisib at the RP2D (80 mg or 60 mg, po, qd). Each treatment cycle is 28 days.

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity (DLT) for Phase 1b	The first cycle (each cycle is 28 days) after administration	To identify the DLT
Overall response rate(ORR) for Phase 2	Up to 24 months	The proportion of patients who achieve complete remission (CR) or partial remission (PR) as the best response.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival(PFS)	Up to 4 years	To investigate the preliminary anti-tumor efficacy
Complete response rate (CRR)	Up to 24 months	Defined as the proportion of patients who achieve complete remission as the best response
Duration of Response(DOR)	Up to 4 years	To investigate the preliminary anti-tumor efficacy
Overall survival(OS)	Up to 4 years	To investigate the preliminary anti-tumor efficacy