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

NCT06083701 | Unknown Phase 1

• 1 other identifier: PUMCH-NHL-016
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• 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

• Objective response rate (ORR)

  Objective response rate (ORR) for phase 2 study

  evaluated every 3 months (up to 24 months)

Secondary Outcomes (4)

• Progression-free survival

  recruitment to data cut-off (up to 5 years)

• Overall survival

  recruitment to data cut-off (up to 5 years)

• complete remission (CR) rate

  evaluated every 3 months (up to 24 months)

• adverse events

  evaluated every treatment cycle (up to 24 months)

Study Arms (1)

Linperlisib plus Chidamide

EXPERIMENTAL

Linperlisib combined with chidamide

Drug: Linperlisib in combined with Chidamide

Interventions

Linperlisib in combined with Chidamide 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;

Linperlisib plus Chidamide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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;

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (2)

Peking Union Medical College Hospital

Beijing, Beijing/China, 100000, China

RECRUITING

Beijing Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Daobin Zhou, Dr

CONTACT

+8613901113623; Zhoudb@pumch.cn

Chong Wei, Dr

CONTACT

+86 13521760705; QH5035@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 16, 2023
• Study Start: September 25, 2023
• Primary Completion: September 25, 2024
• Study Completion: September 25, 2025
• Last Updated: October 16, 2023

Record last verified: 2023-09

Locations

CN (2)