Study of Venetoclax Tablets Crushed and Dissolved Into a Solution in Children and Young Adults With Blood Cancers

What this Trial Is About

Researchers are evaluating the pharmacokinetics of venetoclax when tablets are crushed and dissolved into a liquid solution for children and young adults with blood cancers. This study aims to understand how the body processes venetoclax in this form, as no data currently exists for crushed tablets dissolved in liquid. The study also looks at safety, how different administration routes affect drug levels, and venetoclax concentration in the cerebrospinal fluid. Participants receive venetoclax made from crushed tablets as prescribed by their oncologist, either by mouth or through feeding tubes like nasogastric or gastrostomy tubes. Blood samples are collected at multiple time points between days 5 and 12 after dose ramp-up to measure drug clearance. Optional cerebrospinal fluid samples may also be collected around days 8, 15, 22, or 28 for additional analysis. During the study, peripheral blood is drawn to evaluate venetoclax levels, with optional cerebrospinal fluid sampling for some participants. Researchers monitor drug clearance and safety while patients continue their cancer treatment, which may include other chemotherapy drugs. The study includes patients from birth up to 38 years old, involving multiple visits to collect samples over several weeks to assess how the drug behaves in the body when given as a liquid solution.

Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution