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

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06083701

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral T Cell Lymphoma	Drug: Linperlisib in combined with Chidamide	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 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 Peripheral T-cell Lymphoma: a Prospective, Multi-center Study

Actual Study Start Date :

Sep 25, 2023

Anticipated Primary Completion Date :

Sep 25, 2024

Anticipated Study Completion Date :

Sep 25, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Linperlisib plus 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 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;

Arm

Intervention/Treatment

Experimental: Linperlisib plus 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 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;

Outcome Measures

Primary Outcome Measures

Recommended phase 2 dose (RP2D) [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.
Objective response rate (ORR) [evaluated every 3 months (up to 24 months)]
Objective response rate (ORR) for phase 2 study

Secondary Outcome Measures

Progression-free survival [recruitment 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 [recruitment 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 5.0

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital	Beijing	Beijing/China	China	100000
2	Beijing Hospital	Beijing		China

Sponsors and Collaborators

Peking Union Medical College Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peking Union Medical College Hospital

ClinicalTrials.gov Identifier:

NCT06083701

Other Study ID Numbers:

PUMCH-NHL-016

First Posted:

Oct 16, 2023

Last Update Posted:

Oct 16, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Study Results

No Results Posted as of Oct 16, 2023