Chidamide-BEAM conditioning plus autologous stem cell transplantation forperipheral t-cell lymphoma: A single-arm, single-center, phase 2 trial

Abstract Chidamide-BEAM Conditioning plus Autologous Stem Cell Transplantation for Peripheral T-cell Lymphoma: A single-arm, single-center, phase 2 trial Importance: Considering the therapeutic effect of Chidamide in T-cell lymphoma (TCL), adding Chidamide to the pre-treatment and maintenance regimen of ASCT may have a better therapeutic efficacy. Therefore, this study aimed to evaluate the effect and safety of the Chidamide-BEAM regimen, followed by frontline ASCT and Chidamide maintenance, in TCL patients. Objective To compare the efficacy and safety of Chidamide-BEAM regimen, followed by frontline ASCT and Chidamide maintenance, in PTCL patients. Design, Setting, and Participants Between June 15, 2022 and June 15, 2023, 26 TCL patients were screened and enrolled. Eligible patients were aged 18–65 years; histologically diagnosed as PTCL excluding IPI 0-1 ALK+ anaplastic lymphoma, with CR or PR after frontline chemotherapy. Interventions All patients received chidamide combined with BEAM followed by ASCT. D0 is the day of reinfusion of stem cells. Main Outcomes and Measures The primary endpoint was the 2-year progression-free survival (PFS). The secondary endpoints include 2-year overall survival (OS), complete remission rate, the time of hematopoietic reconstruction, and transplantation-related adverse events Results Between June 15, 2022 and June 15, 2023, 26 patients were enrolled. 2 were excluded for withdrawing consent and 1 for mobilization failure. Of all the 23 patients, 100% were alive at the time of analysis. The median follow-up of surviving patients was 24.6 months (range, 18.2 to 38.7 months). The 2-year PFS and OS for the ITTP were 95.7% (95% CI, 72.9% to 99.4%) and 100.0% (95% CI, 100.0% to 100.0%), respectively. The grade 3-4 non-haematological adverse events included infection (13.0%), hepatic toxicities(8.7%), vomiting (4.3%) and mucositis (4.3%). Conclusions and Relevance Chi-BEAM might be an effective conditioning regimen of ASCT for PTCL and shows a good safety profile. Trial Registration ClinicalTrials.gov identifier: NCT05367856