Individualized Intrathecal Chemotherapy Based on Measurement of Brain Fluid Clearance in Pediatric Patients

Condition studied

Acute lymphoblastic leukemia and lymphoma

Investigational medicinal product(s)

Eligibility

Primary endpoint

Exploratory model-derived BFC indices [absorption half-life (t½abs), time to maximal blood concentration (Tmax) of gadobutrol and maximum concentration (Cmax)] from the predefined gadobutrol popPK model using actual dose and sampling times.

Endpoint detail

Solicited AEs/AESIs Day 0-7, including headache, nausea, dizziness and other predefined symptoms; SAE/SUSAR occurrence; 30-minute post-dose observation findings., Mental Fatigue Scale score at 3 months., Change in neuropsychological test/questionnaire measures from baseline to 3 months and 2 years.