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

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ClinicalTrials.gov Identifier: NCT06037239
Recruitment Status : Recruiting
First Posted : September 14, 2023
Last Update Posted : September 14, 2023
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cutaneous T-cell Lymphoma Drug: Linperlisib in combined with Chidamide Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Linperlisib in Combination With Chidamide for Relapsed and Refractory Cutaneous T-cell Lymphoma: a Prospective, Single-center Study
Actual Study Start Date : July 1, 2023
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Linperlisib + Chidamide
Linperlisib combined with chidamide
 Drug: Linperlisib in combined with Chidamide

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


Outcome Measures
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Primary Outcome Measures :
  1. Recommended phase 2 dose (RP2D)（Phase 1） [ Time Frame: 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.

  2. Objective response rate (ORR)（Phase 2） [ Time Frame: evaluated every 3 months (up to 24 months） ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 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.

  2. Overall survival [ Time Frame: 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.

  3. complete remission (CR) rate [ Time Frame: evaluated every 3 months (up to 24 months） ]
    Treatment responses were assessed according to the 2014 Lugano classification criteria

  4. adverse events [ Time Frame: evaluated every treatment cycle (up to 24 months） ]
    Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06037239


Contacts
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Contact: Wei Zhang +8613681473557 vv1223@vip.sina.com
Contact: Chong Wei +8613521760705 QH5035@163.com

Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Zhang Wei    +86 136 8147 3557    vv1223@vip.sina.com   
Contact: Wei Chong    +86 13521760705    QH5035@163.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
More Information
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT06037239    
Other Study ID Numbers: PUMCH-NHL-015
First Posted: September 14, 2023    Key Record Dates
Last Update Posted: September 14, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin