Phase Ib part
Ann Arbor stage III, DLTs, fatigue, fever, rash, mucositis, bowel typhlitis
NEUTROPENIC FEVER, RESPIRATORY FAILURE, EVENT, MUCOSITIS, EVENTS
From 2014 to 2017, 21 patients were enrolled in phase Ib part. Median age was 57 years (IQR 53;61); 18 (86%) had an Ann Arbor stage III–IV and 8 (38%) an International Prognostic Index (IPI) > 2. The first triplet was treated with Ro at 12 mg/ms, and no DLTs were observed; the subsequent cohorts were treated with Ro at 14 mg/ms. Nine DLTs were reported in seven patients: eight events of grade 3 (three cases of mucositis, one of maculopapular rash, fatigue, fever, respiratory failure, bowel typhlitis) and one event of g4 neutropenic fever. According to the continual reassessment method, the observed DLTs prompted to define 14 mg/ms the recommended dose of romidepsin, with an estimated DLT probability of 34.8% (95% Credibility Interval 16.9–57.0). At the end of induction, ORR was 16/21 (76%), with CR 71%.