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Chidamide-BEAC Plus Autologous Stem Cell Transplantation in High-Risk Non-Hodgkin Lymphoma: A Phase II Clinical Trial
28 Pages Posted: 27 Jan 2023
More...Abstract
Backgroud: Chidamide is a novel subtype-selective histone deacetylase inhibitor that shows potential activity as a conditioning therapy in non-Hodgkin lymphoma (NHL).
Methods: This phase II trial was designed to evaluate the efficacy and safety of chidamide plus carmustine, etoposide, cytarabine, and cyclophosphamide (Chi-BEAC) with autologous stem cell transplantation (ASCT) in treating high-risk and relapsed/refractory aggressive NHLs. The primary objective was to assess the 2-year progression-free survival (PFS). This study was registered at ClinicalTrials.gov (NCT03629873).
Findings: From August 2018 to November 2021, 69 patients were enrolled, including 53 patients with B-cell NHLs (B-NHLs) and 16 with T-cell or natural killer T-cell NHLs (T-NHLs). All patients completed treatment and were successfully engrafted. The median neutrophil engraftment time was 10 days, and the median platelet engraftment time was 11 days. The Chi-BEAC conditioning regimen was tolerated well. At the first follow-up, the response was complete remission (CR) in 79.7% (55/69), partial remission (PR) in 13.0% (9/69) and progressive disease in 7.2% (5/69). 40.9% (9/22) of the patients with PR before ASCT improved to CR. Six patients withdrew consent and were started on maintenance therapy. In the remaining 63 patients (per-protocol set), the 2-year PFS rate was 81.1%, and the 2-year overall survival (OS) rate was 86.1%. The 2-year PFS of those with B-NHLs with upfront ASCT, B-NHLs with salvage ASCT, and T-NHLs were 79.9%, 78.8% and 84.8%, respectively.
Interpretation: The inclusion of chidamide in conditioning regimens for ASCT may improve the outcomes of patients with high-risk or relapsed/refractory aggressive NHLs, particularly in those with T-NHLs.
Trial Registration: This study was registered at ClinicalTrials.gov (NCT03629873).
Funding: National Natural Science Foundation of China, Jiangsu Province’s Medical Elite Programme, Project of National Key Clinical Specialty, Jiangsu Provincial Special Program of Medical Science, National Science and Technology Major Project, China Postdoctoral Science Foundation, Jiangsu Postdoctoral Science Foundation, and Translational Research Grant of NCRCH.
Declaration of Interest: The authors declare no competing financial interests.
Ethical Approval: The study protocol of this study was approved by the Institutional Review Board of Jiangsu Province Hospital and Anhui Provincial Cancer Hospital.
Keywords: Chidamide, BEAC, autologous stem cell transplantation, high-risk, non-Hodgkin lymphoma
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