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

Peripheral T Cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06083701
• Other study ID #: PUMCH-NHL-016
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 25, 2023
• Est. completion date: September 25, 2025

Study information

• Verified date: September 2023
• Source: Peking Union Medical College Hospital
• Contact: Daobin Zhou, Dr
• Phone: +8613901113623
• Email: Zhoudb[@]pumch.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: September 25, 2025
• Est. primary completion date: September 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T Cell Lymphoma

Intervention

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;

Locations

Country	Name	City	State
China	Beijing Hospital	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing/China

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks since the date of first dose
Primary	Objective response rate (ORR)	Objective response rate (ORR) for phase 2 study	evaluated every 3 months (up to 24 months)
Secondary	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.	recruitment to data cut-off (up to 5 years)
Secondary	Overall survival	Overall survival was defined as the time from the date of enrollment to the date of death from any cause.	recruitment to data cut-off (up to 5 years)
Secondary	complete remission (CR) rate	Treatment responses were assessed according to the 2014 Lugano classification criteria	evaluated every 3 months (up to 24 months)
Secondary	adverse events	Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0	evaluated every treatment cycle (up to 24 months)