Table 1.

DLT definitions.

DLTs classified as related to citarinostat
Hematologic toxicity
• Grade 4 neutropenia (ANC < 500/μL) lasting > 7 days. If neutropenia is attributed to citarinostat, ANC is to be reassessed on day 6 to determine whether the AE is a DLT  • Febrile neutropenia (ANC < 1000/μL with a single temperature > 38.3°C or 38.0°C for > 1 hour)  • Grade 4 thrombocytopenia (platelet count < 25,000/μL)  • Grade 3 thrombocytopenia (platelet count 25,000–50,000/μL) with clinically important bleeding  • Grade 4 anemia (life-threatening consequences; urgent intervention indicated)
Nonhematologic toxicity
• All other grade 3/4 nonhematologic toxicities, with the following considerations:   ◦ For grade ≥ 3 nausea, vomiting, and/or diarrhea to be considered a DLT, the event must have persisted for > 72 hours despite maximal medical intervention   ◦ Transaminitis (AST and ALT) > 2 × increase over baseline lasting > 72 hours   ◦ Delay of patient continuing to cycle 2 by > 7 days due to AEs related to citarinostat

AE, adverse event; ALT, alanine aminotransferase; ANC, absolute neutrophil count; AST, aspartate aminotransferase; DLT, dose-limiting toxicity.