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NCT Number: NCT07139353

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Linperlisib

Drug

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

Chidamide

Drug

Chidamide: 20mg, po, biw

Primary outcomes

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

    Time frame: The first cycle (each cycle is 28 days) after administration

    To identify the DLT

  2. Overall response rate(ORR) for Phase 2

    Time frame: Up to 24 months

    The proportion of patients who achieve complete remission (CR) or partial remission (PR) as the best response.

Secondary outcomes

  1. Complete response rate (CRR)

    Time frame: Up to 24 months

    Defined as the proportion of patients who achieve complete remission as the best response

  2. Duration of Response(DOR)

    Time frame: Up to 4 years

    To investigate the preliminary anti-tumor efficacy

  3. Progression-free survival(PFS)

    Time frame: Up to 4 years

    To investigate the preliminary anti-tumor efficacy

  4. Overall survival(OS)

    Time frame: Up to 4 years

    To investigate the preliminary anti-tumor efficacy

Study contacts

Contact information is provided by the study sponsor or research team.

Qingqing Cai

CONTACT

[email protected]

+862087342823

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Linperlisib Combined With Chidamide in the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma: A Prospective, Multicenter, Open-label, Phase Ib/II Clinical Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Aug 24, 2025
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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