Chidamide-BEAM Conditioning plus Autologous Stem Cell Transplantation for T-cell Lymphoma: A Single-Arm, Single-Center, Phase 2 Trial

This clinical trial (NCT05367856) evaluated the Chi-BEAM conditioning regimen followed by frontline autologous stem cell transplantation (ASCT) and chidamide maintenance in T-cell lymphoma (TCL). This study screened and enrolled 23 TCL patients between June 15, 2022, and June 15, 2023. Eligible participants were aged 18–65 years, had histological diagnosis of TCL (excluding ALK-positive anaplastic large cell lymphoma with International Prognostic Index [IPI] score 0–1), and achieved complete remission (CR) or partial remission (PR) after first-line chemotherapy. All enrolled patients received Chi-BEAM followed by ASCT and chidamide maintenance for 2 years, initiated after hematopoietic recovery. The primary endpoint was 2-year progression-free survival (PFS) rate. Secondary endpoints were 2-year overall survival (OS) rate, CR rate, time to hematopoietic reconstruction, and transplantation-related adverse events. At analysis, all 23 patients were alive. Median follow-up was 24.6 months (range, 18.2–38.7 months). The 2-year PFS and OS rates were 95.7% (95% CI, 72.9%-99.4%) and 100.0% (95% CI, 100.0%-100.0%), respectively. Grade 3–4 non-hematological adverse events included infection (13.0%), hepatic toxicity (8.7%), vomiting (4.3%), and mucositis (4.3%). The Chi-BEAM regimen with frontline ASCT followed by chidamide maintenance represents a potentially effective and well-tolerated treatment strategy for TCL, showing promising survival outcomes and a manageable safety profile.