Vincristine and concomitant azole therapy in pediatric acute lymphoblastic leukemia patients - a pharmacokinetic study
- Conditions
- Acute lymphoblastic leukemia - cancer of white blood cells10024324
- Registration Number
- NL-OMON35826
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
- Diagnosed with acute lymphoblastic leukemia
- Treatment according to nationwide DCOG ALL protocol, induction therapy and/or intensification therapy for Medium Risk Group patients
- Vincristine 1.5 mg/m2 or 2 mg/m2 as iv bolus according to nationwide ALL protocol
- Age 1 - < 18 years
- Azole group: standard azole prophylaxis according to institutional guidelines (itraconazole, voricoanzole therapy started at least 5 days before planned vincristine sampling, fluconazole 7 days)
- Written informed consent from patients or from parents or legal guardians for minor patients, according to local law and regulations
- Blood sampling not possible
- Patient refusal or parent refusal
- Not able to comply with scheduled follow-up
- Patients with underlying neurological disease such as Charcot-Marie-Tooth disease or Guillain-Barre syndrome
- Patients with underlying Down syndrome
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Blood levels of vincristine and the metabolite, M1 will be analyzed after<br /><br>administration of vincristine. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Blood levels of the azoles will be analyzed at the same time. One whole blood<br /><br>sample for DNA extraction and genotyping will be collected from each patient<br /><br>enrolled in this study. Furthermore, we will study toxicity.</p><br>