RecruitingPhase 1Phase 2NCT06421948

Linperlisib Combined With Chidamide in Patients With PTCL

PI3Kδ Inhibitor Linperlisib Combined With HDAC Inhibitor Chidamide Versus CHOP in Patients With Peripheral T-cell Lymphoma: a Multicenter, Open Label, Phase Ib/II Study

Sponsor

Yanyan Liu

Enrollment

134 participants

Start Date

May 25, 2024

Study Type

INTERVENTIONAL

Conditions

Peripheral T Cell Lymphoma

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two targeted drugs — linperlisib (a PI3K inhibitor) and chidamide (an HDAC inhibitor) — for people with peripheral T-cell lymphoma (PTCL), a type of aggressive blood cancer. Both drugs work on different pathways inside cancer cells to stop them from growing. **You may be eligible if...** - You are aged 18–75 (or up to 80 for earlier study phases) - You have newly diagnosed PTCL confirmed by biopsy (certain subtypes only) - Your overall health is acceptable (ECOG 0–2) - Your expected survival is at least 6 months - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - Your PTCL is anaplastic large cell, NK/T-cell, or primary cutaneous type - Your cancer is not measurable - You have very poor organ function - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLinperlisib 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.

DRUGLinperlisib 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.

DRUGLinperlisib 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.

DRUGcyclophosphamide, 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.