Evaluation of Initial Enoxaparin Dosing and Antifactor Xa Levels in Infants Admitted to the Neonatal Intensive Care Unit.

Patients with relapsed or refractory (R/R) peripheral T-cell lymphomas (PTCL) require lineage-specific therapies to bridge to hematopoietic stem cell transplantation (HSCT). A previous phase 1/2 study of duvelisib/romidepsin (duv/romi) reported an overall response rate (ORR) of 58% and a complete response rate (CRR) of 42% with reduced grade 3 to 4 transaminitis (14%). We report real-world duv/romi outcomes in a multicenter, 38-patient R/R PTCL cohort. The median age at diagnosis was 62 years. Histological subtypes included nodal T follicular helper cell (nTFH; n = 17), PTCL-not otherwise specified (n = 14), cutaneous T-cell lymphoma (TCL; n = 3), extranodal natural killer/TCL (n = 1), ALK-negative anaplastic large cell lymphoma (n = 1), adult T-cell leukemia/lymphoma (n = 1), and hepatosplenic TCL (n = 1). The median previous therapy count was 1 (interquartile range [IQR], 1-2); 15 patients relapsed and 23 were refractory to prior treatment, including 8 prior HSCT (5 autologous, 3 allogeneic). After a median of 3 cycles (IQR, 2-4), ORR and CRR were 61% and 47%, respectively, with higher ORR (82% vs 43%) and CRR (71% vs 29%) in nTFH versus non-nTFH. The median progression-free survival and overall survival (HSCT-censored) were 11 and 16 months for nTFH, versus 3.3 and 8.3 months for non-nTFH. The median time to response was 1.9 months (IQR, 1.7-2.6), duration of response was 21 months, and time to next therapy was 17 months. After duv/romi, 11 patients bridged to allo-HSCT. Treatment was well tolerated; the most common grade 3 to 4 toxicities were lymphopenia (n = 15), neutropenia (n = 15), thrombocytopenia (n = 10), and transaminitis (n = 6), seldom leading to discontinuation (n = 4) or death (n = 1). These findings reinforce duv/romi's efficacy and bridging role to curative HSCT in high-risk R/R PTCL.