Maintenance therapy with romidepsin after autologous stem-cell transplant for peripheral T-cell lymphoma

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.