Maintenance therapy with romidepsin after autologous stem-cell transplant for peripheral T-cell lymphoma
Year: 2025
Type: article
Study design: Clinical Trial
Abstract: ABSTRACT: Patients with peripheral T-cell lymphoma (PTCL) have suboptimal outcomes. Autologous hematopoietic stem-cell transplantation (AHCT) is a therapeutic strategy for patients in first complete remission (CR1) or first partial remission (PR1), with median intent-to-treat progression-free survival (PFS) of 36% to 48%. Romidepsin is a histone deacetylase inhibitor used for treatment of relapsed/refractory PTCL. We present a multicenter study to evaluate the PFS of patients receiving maintenance therapy with romidepsin after AHCT. Twenty-six patients who underwent AHCT in CR1 or PR1 were evaluated for the primary end point of 2-year PFS. The exploratory cohort enrolled patients who underwent transplantation during or after CR/PR2 (n = 5) or high-risk histologies (n = 2). Patients underwent AHCT with carmustine, etoposide, cytarabine, and melphalan conditioning. Romidepsin 14 mg/m2 was started on days 42 to 80 after -AHCT every other week until 6 months of -AHCT, every 3 weeks between 6 months and 1-year of -AHCT, and every 4 weeks between 1 and 2 years of -AHCT. PFS was estimated using the Kaplan-Meier analysis. Forty-seven patients consented and 13 did not receive romidepsin. With a median progression-free follow-up of 32 months (range, 24-36), 15 of the first 25 patients in cohort 1 were progression-free after 2 years. The estimated 2-year PFS was 62% (95% confidence interval, 45-83). The most common toxicities were fatigue (n = 24, 73%), decreased platelets (n = 16, 48%), and anemia (n = 16, 48%). Although the study did not meet its desired primary efficacy end point, maintenance romidepsin was feasible, with a favorable estimated 2-year PFS of 62%. This trial was registered at www.ClinicalTrials.gov as #NCT01908777.
Source: Blood Advances
Authors: Niloufer Khan, Parastoo B. Dahi, Farhad Khimani, Andrei R. Shustov, Mazyar Shadman, Jia Ruan, Alison J. Moskowitz, Andrew D. Zelenetz, Ariela Noy, David J. Straus, Pamela Drullinsky, Audrey Hamilton, Anita Kumar, Craig S. Sauter, Gunjan L. Shah, Matthew J. Matasar, Esther Drill, Theresa Davey, Helen Hancock, Nivetha Ganesan, Natasha Galasso, Koen van Beisen, Sergio Giralt, Steven M. Horwitz
Language: English
Subfield: Pathology and Forensic Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,800
Award: Cancer Center Support Grant
OpenAlex ID: W4409149644