Status:
NOT_YET_RECRUITING
Linperlisib Combined With Chidamide in the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma
Lead Sponsor:
Sun Yat-sen University
Conditions:
Peripheral T Cells Lymphoma (PTCL)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 periphe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT07139353
Start Date
September 15 2025
End Date
September 1 2029
Last Update
August 24 2025
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