Table II.

Conventional non-hematologic DLT definition

Although the DLT definitions used by different clinical trial consortia vary, many are similar to the one used in the U.S. by the Children’s Oncology Group (COG):

Non-hematologic dose-limiting toxicity: Any Grade 3 or greater non-hematological toxicity attributable to the investigational drug.

Common exclusions: Grade 3 and 4 nausea and vomiting Grade 3 transaminase (AST/ALT) elevation that returns to grade ≤ 1 or baseline prior to the next treatment cycle Grade 3 fever or infection Electrolyte disturbances due to tumor lysis syndrome Alopecia