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

Primary Purpose

Cutaneous T-cell Lymphoma

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Linperlisib in combined with Chidamide
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous T-cell Lymphoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Linperlisib + Chidamide

Arm Description

Linperlisib combined with chidamide

Outcomes

Primary Outcome Measures

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.
Objective response rate (ORR)（Phase 2）

Secondary Outcome Measures

Progression-free survival
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
Overall survival was defined as the time from the date of enrollment to the date of death from any cause.
complete remission (CR) rate
Treatment responses were assessed according to the 2014 Lugano classification criteria
adverse events
Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Full Information

First Posted
September 8, 2023
Last Updated
September 8, 2023
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06037239
Brief Title
Phase I/II Study of Linperlisib Plus Chidamide for R/R Cutaneous T-cell Lymphoma: a Prospective, Single-center Study
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous T-cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Linperlisib + Chidamide
Arm Type
Experimental
Arm Description
Linperlisib combined with chidamide
Intervention Type
Drug
Intervention Name(s)
Linperlisib in combined with Chidamide
Intervention Description
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
Primary Outcome Measure Information:
Title
Recommended phase 2 dose (RP2D)（Phase 1）
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.
Time Frame
4 weeks since the date of first dose
Title
Objective response rate (ORR)（Phase 2）
Time Frame
evaluated every 3 months (up to 24 months）
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
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.
Time Frame
Baseline up to data cut-off (up to 5 years)
Title
Overall survival
Description
Overall survival was defined as the time from the date of enrollment to the date of death from any cause.
Time Frame
Baseline up to data cut-off (up to 5 years)
Title
complete remission (CR) rate
Description
Treatment responses were assessed according to the 2014 Lugano classification criteria
Time Frame
evaluated every 3 months (up to 24 months）
Title
adverse events
Description
Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time Frame
evaluated every treatment cycle (up to 24 months）

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Zhang
Phone
+8613681473557
Email
vv1223@vip.sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chong Wei
Phone
+8613521760705
Email
QH5035@163.com
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang Wei
Phone
+86 136 8147 3557
Email
vv1223@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Wei Chong
Phone
+86 13521760705
Email
QH5035@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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