Clinical trial · Interventional
Phase I/II Study of Linperlisib Plus Chidamide for R/R Cutaneous T-cell Lymphoma: a Prospective, Single-center Study
Phase I/II Study of Linperlisib in Combination With Chidamide for Relapsed and Refractory Cutaneous T-cell Lymphoma: a Prospective, Single-center Study
- 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)
HDAC inhibitor chidamide and PI3K inhibitor linperlisib has shown clinical activity as mono therapy in PTCL. The combination of duvelisib and romidepsin is highly active against relapsed and refractory T-cell lymphomas including cutaneous T-cell lymphomas (CTCLs). The aim of this study is to further explore the efficacy and safety of HDAC inhibitor chidamide combined with PI3K inhibitor linperlisib in the treatment of relapsed and refractory CTCLs.
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 |
|---|---|---|---|
| Cutaneous T-cell Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Linperlisib in combined with Chidamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Linperlisib + Chidamide
- description
- Linperlisib combined with chidamide
- interventionNames
- Drug: Linperlisib in combined with Chidamide
Primary outcomes (2)
- measure
- Recommended phase 2 dose (RP2D)（Phase 1）
- timeFrame
- 4 weeks since the date of first dose
- description
- Recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) will be established according to the incidence of dose-limiting toxicities (DLTs) of escalated doses of linperlisib.
- measure
- Objective response rate (ORR)（Phase 2）
- timeFrame
- evaluated every 3 months (up to 24 months）
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Ages 18-75; * Mycosis fungoides and Sezary syndrome confirmed by histopathology; * Patients with measurable lesions, with or without extra-cutaneous lesions, and clinical stage IIB-IVB; * No remission or relapse after at least one systemic therapy (including total body electron irradiation, becarodine, retinoic acid, interferon, photoseparation and replacement, methotrexate, chidamide, etc.); * ECOG score of 0-2; * Adequate bone marrow hematopoietic function: neutrophil count (ANC) ≥1.5×109/L, platelet count (PLT) ≥80×109/L, hemoglobin (HGB) ≥90g/L; * Adequate organ function: NYHA grade 1-2, LVEF≥50%, ALT\<2.5UNL, TBil\<1.5ULN, SPO2 \> 93%@RA, SCr\>60ml/(min·1.73m2); Exclusion Criteria: * Acute myocardial infarction or unstable angina, congestive heart failure, symptomatic arrhythmia, and significantly prolonged QT interval (\> 450ms in men and \> 470ms in women) within 6 months; * Uncontrolled active infections; * Active hepatitis B and C infection (hepatitis B virus DNA over 1×103 copies /mL is excluded, hepatitis C virus RNA over 1×103 copies /mL is excluded) * Pregnant or lactating women; * Investigators judged that they were not suitable to participate in the study
References
Publications (1)
- DERIVEDPang Z, Wang Y, Liu Z, Zhang S, Wei C, Xu Z, Wang Z, Chen H, Liu J, Zhang W. Linperlisib Plus Chidamide in Relapsed or Refractory Cutaneous T-Cell Lymphoma: A Nonrandomized Clinical Trial. JAMA Dermatol. 2025 Sep 1;161(9):923-930. doi: 10.1001/jamadermatol.2025.1926. PMID 40601335