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Efficacy and Safety of Chidamide Combined With BEAM Pretreatment Regimen in Autologous Transplantation for T-cell Lymphoma

T Cell Lymphoma Clinical Trial

Official title:
Efficacy and Safety of Chidamide Combined With BEAM(Carmustine, Etoposide Cytarabine and Melphalan) Pretreatment in Autologous Transplantation for T-cell Lymphoma: a Single-center, Single-arm Clinical Study

Clinical Trial Summary

This single-center, single-arm clinical study will evaluate the efficacy and safety of Chidamide combined with BEAM Pretreatment Regimen in ASCT treatment of TCL patients.

Clinical Trial Description

T cell lymphoma (TCL) is a group of highly heterogeneous aggressive non-Hodgkin lymphomas with different pathogenesis and clinical prognosis. Despite the survival benefits of Anthracycline-based chemotherapy bridging autologous stem cell transplantation (ASCT), 40% to 50% of TCL patients fail to respond to treatment and relapse or die within a short period of time. In 2021, a multicenter, single-arm, open Phase II trial of Chidamide combined with BEAC as a pretreatment regimen for ASCT of high-risk and relapsed/refractory lymphoma was presented at the ASH Meeting (NCT03629873). The results confirmed that Chidamide has a good prospect in ASCT. Chi-BEAC can increase 2Y-PFS from 55% to 93.3% and 2Y-OS from 58% to 94% in TCL patients after ASCT compared with the historical control group, with good tolerance.In order to provide a new program for improving survival rate, this single-center, single-arm clinical study will evaluate the efficacy and safety of Chidamide combined with BEAM Pretreatment Regimen in ASCT treatment of TCL patients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05367856
Study type Interventional
Source Ruijin Hospital
Contact Weili Zhao
Phone +862164370045
Email zwl_trial@163.com
Status Recruiting
Phase Phase 2
Start date May 28, 2022
Completion date June 1, 2025
View Details
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