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

NCT ID: NCT07139353

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2029-09-01

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

Conditions

Peripheral T Cells Lymphoma (PTCL)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Linperlisib Combined with 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.

Group Type: EXPERIMENTAL

Linperlisib

Intervention Type: DRUG

Linperlisib: 80 mg or 60 mg, po, qd (phase Ib); RP2D (phase II)

Chidamide

Intervention Type: DRUG

Chidamide: 20mg, po, biw

Interventions

Linperlisib

Linperlisib: 80 mg or 60 mg, po, qd (phase Ib); RP2D (phase II)

Intervention Type: DRUG

Chidamide

Chidamide: 20mg, po, biw

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Qingqing Cai

MD. PhD.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Qingqing Cai

Role: CONTACT

caiqq@sysucc.org.cn

+862087342823

Other Identifiers

B2025-420

Identifier Type: -

Identifier Source: org_study_id