Phase I/II Study of Linperlisib Plus Chidamide for R/R Cutaneous T-cell Lymphoma: a Prospective, Single-center Study

Phase 1

Recruiting

• Conditions: Cutaneous T-cell Lymphoma
• Interventions: Drug: Linperlisib in combined with Chidamide

• Registration Number: NCT06037239
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study Start: 2023-07-01
• Study First Submitted: 2023-09-08
• Study First Submitted QC: 2023-09-08
• Last Update Submitted: 2023-09-08
• Study First Posted: 2023-09-14
• Last Update Posted: 2023-09-14
• Primary Completion: 2024-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Linperlisib + Chidamide	Linperlisib in combined with Chidamide	Linperlisib combined with chidamide

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)（Phase 2）	evaluated every 3 months (up to 24 months）
Recommended phase 2 dose (RP2D)（Phase 1）	4 weeks since the date of first dose	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.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	Baseline up to data cut-off (up to 5 years)	Progression-free survival was defined as the time from the date of enrollment until the date of the first documented day of disease progression or relapse, or death from any cause, whichever occurred first.
Overall survival	Baseline up to data cut-off (up to 5 years)	Overall survival was defined as the time from the date of enrollment to the date of death from any cause.
complete remission (CR) rate	evaluated every 3 months (up to 24 months）	Treatment responses were assessed according to the 2014 Lugano classification criteria
adverse events	evaluated every treatment cycle (up to 24 months）	Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China