Linperlisib Combined With Chidamide in Patients With PTCL

Status Recruiting

Clinical Trial Summary

The goal of this clinical trial is to determine the maximum tolerated dose (MTD) of PI3Kδ inhibitor linperlisib when combined with fixed dose of HDAC inhibitor chidamide in participants with peripheral T-cell lymphoma (PTCL), and to compare the combination of linperlisib and chidamide to standard CHOP (cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisone) regimen chemotherapy in the frontline treatment of PTCL to see which therapy is better.

Clinical Trial Description

In the phase Ib trial, participants with newly diagnosed or relapsed/refractory PTCL will receive fixed dose of chidamide (20 mg, twice a week) and escalating dose of linperlisib (40 mg, 60 mg, or 80 mg, once a day), to find out the optimal dose of linperlisib. In the phase II trial, participants with newly diagnosed PTCL will be randomized into experimental arm (arm A) to receive linperlisib in combination with chidamide, or control arm (arm B) to receive standard CHOP regimen chemotherapy. Interim efficacy assessment will be performed after three cycles of treatment. Responded participants will receive another three cycles of treatment. After a total of 6 cycles of treatment, participants can choose autologous hematopoietic stem cell transplantation, maintenance treatment with linperlisib and/or chidamide, or watch and wait. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06421948
Study type	Interventional
Source	Henan Cancer Hospital
Contact	Yanyan Liu
Phone	86 037165587791
Email	yyliu@zzu.edu.cn
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	January 1, 2024
Completion date	May 31, 2026

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