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

Patients with peripheral T-cell lymphomas (PTCL) have suboptimal outcomes. Autologous hematopoietic stem cell transplant (AHCT) is a therapeutic strategy for patients in first complete or partial remission (CR1 or PR1), with median intent to treat progression-free survival (PFS) of 36-48%. Romidepsin is a histone deacetylase inhibitor used for treatment of relapsed/refractory PTCL. We present the first multicenter study to evaluate PFS of patients receiving maintenance therapy with romidepsin after AHCT. Twenty-six patients transplanted in CR1 or PR1 were evaluable for the primary endpoint of 2-year PFS. An exploratory cohort enrolled pts either transplanted in or after CR/PR2 (n=5) or with high-risk histologies (n=2). Patients underwent AHCT with carmustine, etoposide, cytarabine and melphalan (BEAM) conditioning. Romidepsin 14 mg/m2 started at days 42-80 post AHCT every other week until six months post AHCT, every three weeks between six months and one year post AHCT, and every four weeks between one - two years post AHCT. PFS was estimated by Kaplan-Meier. 47 patients consented; 13 did not receive romidepsin. With median progression-free follow up of 32 months (range 24-36 months), 15 out of the first 25 patients in Cohort 1 were progression-free after 2 years. Estimated 2-year PFS was 62% (45-83%, 95% CI). Across cohorts, 5 patients required dose reduction. Most common toxicities were fatigue (n=24, 73%), decreased platelets (n=16, 48%) and anemia (n=16, 48%). While the study did not meet its desired primary efficacy endpoint, maintenance romidepsin was feasible with a favorable estimated 2-year PFS of 62%, relative to historical data. Clinicaltrials.gov NCT01908777.