Clinical trial · Interventional
Linperlisib Combined With Chidamide in the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma
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
NCT07139353CI-TRIAL-00094077not yet recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral T Cells Lymphoma (PTCL) | Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chidamide | Drug | — | UNRESOLVED |
| Linperlisib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Linperlisib Combined with Chidamide
- description
- 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.
- interventionNames
- Drug: Linperlisib
- Drug: Chidamide
Primary outcomes (2)
- measure
- Dose-limiting toxicity (DLT) for Phase 1b
- timeFrame
- The first cycle (each cycle is 28 days) after administration
- description
- To identify the DLT
- measure
- Overall response rate(ORR) for Phase 2
- timeFrame
- Up to 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.