NCT06037239

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
53

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2023

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

September 14, 2023

Status Verified

July 1, 2023

Enrollment Period

1 year

First QC Date

September 8, 2023

Last Update Submit

September 8, 2023

Conditions

Cutaneous T-cell Lymphoma

Outcome Measures

Primary Outcomes (2)

  • Recommended phase 2 dose (RP2D)（Phase 1）

    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.

    4 weeks since the date of first dose

  • Objective response rate (ORR)（Phase 2）

    evaluated every 3 months (up to 24 months）

Secondary Outcomes (4)

  • Progression-free survival

    Baseline up to data cut-off (up to 5 years)

  • Overall survival

    Baseline up to data cut-off (up to 5 years)

  • complete remission (CR) rate

    evaluated every 3 months (up to 24 months）

  • adverse events

    evaluated every treatment cycle (up to 24 months）

Study Arms (1)

Linperlisib + Chidamide

EXPERIMENTAL

Linperlisib combined with chidamide

Drug: Linperlisib in combined with Chidamide

Interventions

Linperlisib in combined with ChidamideDRUG

Phase 1: dose escalation phase. Drug Linperlisib: 3 dose level of 40mg, 60mg, 80mg qd; Drug Chidamide: fixed dose of 20mg twice weekly. Phase 2：dose expansion phase. Drug Linperlisib: RP2D established in the phase I study; Drug Chidamide: fixed dose of 20mg twice weekly in a 4-week cycle

Linperlisib + Chidamide

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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);

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (1)

  • Pang 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: 40601335DERIVED

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Wei Zhang

CONTACT

+8613681473557vv1223@vip.sina.com

Chong Wei

CONTACT

+8613521760705QH5035@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2023

First Posted

September 14, 2023

Study Start

July 1, 2023

Primary Completion

July 1, 2024

Study Completion

July 1, 2025

Last Updated

September 14, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)