Back to resultsPhase I/II Study of Linperlisib Plus Chidamide for R/R Peripheral T-cell Lymphoma: a Prospective, Multi-center Study
Primary Purpose
Peripheral T Cell Lymphoma
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Linperlisib in combined with Chidamide
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral T Cell Lymphoma
Eligibility Criteria
Inclusion Criteria: Ages 18-75; Pathologically confirmed diagnosis of PTCL, not otherwise specified (PTCL, NOS), anaplastic large cell lymphoma (ALCL), angioimmunoblastic T-cell lymphoma (AITL), or other PTCL subtypes that the researchers considered to be eligible; Fulfills the criteria for relapsed/refractory lymphoma; There must be at least one measurable lesion: for measurable lymph node, the longest diameter should be > 1.5cm, for measurable extranodal lesion, the longest diameter should be > 1.0cm; 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<3UNL, TBil<2ULN, SPO2 > 93%@RA, SCr>60ml/(min·1.73m2); Exclusion Criteria: Extranodal natural killer/T cell lymphoma; Previously treated with PI3K inhibitors; 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;
Sites / Locations
- Peking Union Medical College HospitalRecruiting
- Beijing HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Linperlisib plus Chidamide
Arm Description
Linperlisib combined with chidamide
Outcomes
Primary Outcome Measures
Recommended phase 2 dose (RP2D)
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)
Objective response rate (ORR) for phase 2 study
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 5.0
Full Information
NCT ID
NCT06083701
First Posted
October 9, 2023
Last Updated
October 9, 2023
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06083701
Brief Title
Phase I/II Study of Linperlisib Plus Chidamide for R/R Peripheral T-cell Lymphoma: a Prospective, Multi-center Study
Official Title
Phase I/II Study of Linperlisib in Combination With Chidamide for Relapsed and Refractory Peripheral T-cell Lymphoma: a Prospective, Multi-center Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 25, 2023 (Actual)
Primary Completion Date
September 25, 2024 (Anticipated)
Study Completion Date
September 25, 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 for relapsed and refractory PTCLs. 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 PTCLs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral 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
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Linperlisib plus 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 in a 4-week cycle;
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)
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)
Description
Objective response rate (ORR) for phase 2 study
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
recruitment 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
recruitment 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 5.0
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;
Pathologically confirmed diagnosis of PTCL, not otherwise specified (PTCL, NOS), anaplastic large cell lymphoma (ALCL), angioimmunoblastic T-cell lymphoma (AITL), or other PTCL subtypes that the researchers considered to be eligible;
Fulfills the criteria for relapsed/refractory lymphoma;
There must be at least one measurable lesion: for measurable lymph node, the longest diameter should be > 1.5cm, for measurable extranodal lesion, the longest diameter should be > 1.0cm;
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<3UNL, TBil<2ULN, SPO2 > 93%@RA, SCr>60ml/(min·1.73m2);
Exclusion Criteria:
Extranodal natural killer/T cell lymphoma;
Previously treated with PI3K inhibitors;
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daobin Zhou, Dr
Phone
+8613901113623
Email
Zhoudb@pumch.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Chong Wei, Dr
Phone
+86 13521760705
Email
QH5035@163.com
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing/China
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daobin Zhou, PhD&MD
Phone
010-69155020
Email
zhoudb@pumch.cn
Facility Name
Beijing Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Liu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Phase I/II Study of Linperlisib Plus Chidamide for R/R Peripheral T-cell Lymphoma: a Prospective, Multi-center Study
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