NCT05367856

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• T Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Chidamide combined with BEAM	Chidamide: 30mg po D-7,D-4,D-1 and D+3 Carmustine: 300mg/m2 ivgtt D-7 Etoposide: 100mg/m2/d ivgtt q12h D-6-D-3 Cytarabine: 200mg/m2/d ivgtt q12h D-6-D-3 Melphalan: 140mg/m2 ivgtt D-2

Timeline

• Start date: 2022-05-28
• Primary completion: 2024-06-01
• Completion: 2025-06-01
• First posted: 2022-05-10
• Last updated: 2022-09-29

Locations

1 site across 1 country: China