Linperlisib Combined With Chidamide in Patients With PTCL

NCT06421948 · tracked via the Priya Life Science China tracker

Sponsor

Yanyan Liu

Phase

Phase 1/2

Started

2024-05-25

Last updated

2025-12-05

Condition(s) studied

Peripheral T-cell Lymphoma

Investigational drug(s) / intervention(s)

Linperlisib and chidamideLinperlisib and chidamideLinperlisib and chidamidecyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisone

Linperlisib and chidamide: Linperlisib is a selective PI3Kδ inhibitor that has been approved in mainland China for the treatment of relapsed or refractory follicular lymphoma, with a recommended monotherapy dose of 80 mg orally once daily. In this study, Linperlisib was administered at three dose levels of 40 mg, 60 mg, and 80 mg in order to determine the recommended Phase II dose (RP2D) when combined with a fixed dose of Chidamide (20 mg twice weekly). Chidamide has been approved in mainland China for the treatment of relapsed or refractory PTCL and double-expressor DLBCL. In this study, it was administered at a fixed dose of 20 mg twice weekly in combination with Linperlisib.

Linperlisib and chidamide: All patients received Linperlisib at the RP2D dose once daily and Chidamide 20 mg twice weekly, with each treatment cycle lasting 3 weeks. After three cycles, an interim efficacy assessment was performed. Patients who showed a therapeutic response received an additional three cycles, and the final efficacy evaluation was conducted after six cycles.

Linperlisib and chidamide: Patients received Linperlisib at the RP2D dose once daily and Chidamide 20 mg twice weekly, with each treatment cycle lasting 3 weeks. After three cycles, an interim efficacy assessment was performed. Patients who showed a therapeutic response received an additional three cycles, and the final efficacy evaluation was conducted after six cycles.

cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisone: Patients receive conventional CHOP (or CHOP-like regimens such as CHOPE or EPOCH) chemotherapy, with 3 weeks for one cycle. After three cycles, an interim efficacy assessment was performed. Patients who showed a response received an additional three cycles, and the final efficacy evaluation was conducted after six cycles.

Study summary

The phase Ib part of this study aims to determine the recommended phase II dose （RP2D）of linperlisib in combination with chidamide for the treatment of peripheral T-cell lymphoma (PTCL).

The phase IIa part is designed to evaluate the preliminary efficacy and safety of the linperlisib plus chidamide regimen in newly diagnosed PTCL patients.

The phase IIb part compares the efficacy and safety of linperlisib combined with chidamide versus the standard CHOP (CHOP-like) regimen in newly diagnosed PTCL patients.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * Age 18-75 years at the time of inclusion (Age 18-80 years for phase Ib and IIa study) * Patients with a newly diagnosed and histologically confirmed PTCL (phase Ib study includes both newly diagnosed and relapsed/refractory PTCL). Anaplastic large cell lymphoma, NK/T-cell lymphoma, and primary cutaneous T-cell lymphoma are not included. * ECOG PS 0-2 at protocol entry * Estimated life expectancy of 6 months or longer * Measurable disease * Hemoglobin ≥ 8 g/dL (≥5 mmol/l); Platelets ≥ 75 x 10E9/L; Absolute neutrophil count ≥ 1.0 x 10E9/L; Platelets ≥ 50 x 10E9/L permitted if documented bone marrow involvement; Serum bilirubin ≤ 1.5 x upper limit of normal (ULN); Serum glutamic-oxaloacetic transaminase (AST) and/or serum glutamic-pyruvic transaminase (ALT) ≤ 2.5 x ULN, or ≤ 5 x ULN if elevation is due to hepatic involvement by lymphoma; Serum creatinine ≤ 1.5 x ULNb; left ventricular ejection fraction (LVEF) ≥ 50% * Women of childbearing potential must use safe anticonception (e.g. contraceptive pills, intrauterine devices etc.) during the study and 12 months after the last administration of study drugs; Male patients must use contraception for the duration of the study and 6 months after the last administration of study drugs if his partner is of childbearing potential * Written informed consent Exclusion Criteria: * Patients previously treated with PI3K inhibitor * Patients previously treated with chidamide (phase Ib study is not limited by this item) * Suspected or documented central nervous system involvement by lymphoma * Patients with positive HIV and/or active hepatitis B and/or hepatitis C infection * Patients with active, uncontrolled infections * Unwillingness or inability to comply with the protocol * Deemed 'unfit' by the treating physician * Pregnant and/or breastfeeding women * Concurrent severe and/or uncontrolled medical disease which is not lymphoma-related * Patients with contraindications to chemotherapy * Known hypersensitivity to one or more of the study drugs

Primary outcome measure(s)

Recommended Phase 2 Dose (RP2D) — Approximately 3 months
Phase Ib
CRR (Complete response rate) — Through study completion, an average of 3 years
Phase IIa and IIb

Trial sites (6)

Facility	City	Region	Status
Affiliated Cancer Hospital of Zhengzhou University	Zhengzhou	Henan	Recruiting
Liling Zhang	Wuhan	Hubei	Recruiting
Yajun Li	Changsha	Hunan	Recruiting
Ming Jiang	Chengdu	Sichuan	Recruiting
Huilai Zhang	Tianjin	Tianjin Municipality	Recruiting
Cong Li	Hangzhou	Zhejiang	Recruiting

More Yanyan Liu trials in China

Real-World Study of Bispecific Antibody in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma Starting soon

Other trials for the same condition

Golidocitinib Plus CHOP in Newly Diagnosed PTCL Recruiting

A Clinical Study of CHT101 in CD70-Positive Relapsed or Refractory Hematological Malignancies Recruiting

Bendamustine Combined With Chidamide and Lenalidomide for Relapsed and Refractory PTCL Patients Recruiting

Clinical Study of XNW5004 Combined With CHOP/CHOEP in the Treatment of Untreated Peripheral T-Cell Lymphoma Recruiting

Linperlisib in Combination With CHOP in Previously Untreated Peripheral T-Cell Lymphoma Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06421948 on ClinicalTrials.gov ↗ ← All trials in China