Dose-Limiting Toxicity (DLT)
DLTA predefined adverse event of sufficient severity that it prevents further dose escalation in a clinical trial, typically graded according to CTCAE (Common Terminology Criteria for Adverse Events). DLTs are the primary safety endpoint in Phase I dose-escalation studies and define the maximum tolerated dose. The specific definition of DLT varies by therapeutic area and is prospectively specified in the study protocol.
أمثلة
- Cytotoxic chemotherapy: Grade 4 neutropenia lasting >7 days or febrile neutropenia as DLT
- Targeted therapy: Grade 3 skin rash (acneiform dermatitis) as DLT for EGFR inhibitors
- Immunotherapy: Grade 3+ immune-related hepatitis or colitis as DLT for checkpoint inhibitors
هل تعلم؟
A predefined adverse event of sufficient severity that it prevents further dose escalation in a clinical trial, typically graded according to CTCAE (Common Terminology Criteria for Adverse Events). DLTs are …