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

NCT ID: NCT06083701

Last Updated: 2023-10-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-25
• Study Completion Date: 2025-09-25

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.

Conditions

Peripheral T Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Linperlisib plus Chidamide

Linperlisib combined with chidamide

Group Type: EXPERIMENTAL

Linperlisib in combined with Chidamide

Intervention Type: DRUG

• 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;

Interventions

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;

Intervention Type: DRUG

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking Union Medical College Hospital

Beijing, Beijing/China, China

Site Status: RECRUITING

Beijing Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Daobin Zhou, Dr

Role: CONTACT

Zhoudb@pumch.cn

+8613901113623

Chong Wei, Dr

Role: CONTACT

QH5035@163.com

+86 13521760705

Facility Contacts

Daobin Zhou, PhD&MD

Role: primary

zhoudb@pumch.cn

010-69155020

Hui Liu

Role: primary

Other Identifiers

PUMCH-NHL-016

Identifier Type: -

Identifier Source: org_study_id