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

NCT07139353 | Not Yet Recruiting Phase 1

• 1 other identifier: B2025-420
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

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)

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity (DLT) for Phase 1b

  To identify the DLT

  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.

  Up to 24 months

Secondary Outcomes (4)

• Complete response rate (CRR)

  Up to 24 months

• Duration of Response(DOR)

  Up to 4 years

• Progression-free survival(PFS)

  Up to 4 years

• Overall survival(OS)

  Up to 4 years

Study Arms (1)

Linperlisib Combined with Chidamide

EXPERIMENTAL

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.

Drug: Linperlisib; Drug: Chidamide

Interventions

Linperlisib DRUG

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

Linperlisib Combined with Chidamide

Chidamide DRUG

Chidamide: 20mg, po, biw

Linperlisib Combined with Chidamide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

MeSH Terms

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Central Study Contacts

Qingqing Cai

CONTACT

+862087342823; caiqq@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. PhD.

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 24, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2029
• Last Updated: August 24, 2025

Record last verified: 2025-08