ALL, children, vincristine, azole therapy, pharmacokinetics
Conditions
Interventions
No intervention, observation of blood levels of vincristine.
Sponsors
AMC Medical Centre Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosed with acute lymphoblastic leukemia; 2. Treatment according to DCOG ALL-10-protocol, induction phase and intensification phase for Medium Risk Group patients; 3. Vincristine 1.5 mg/m2 or 2 mg/m2 as iv bolus; 4. Age 1 - < 18 years; 5. Azole group: Azole therapy started at least 5 days before planned VCR treatment (7 days for fluconazole); 6. Written informed consent from patients or from parents or legal guardians for minor patients, according to local law and regulations.
Exclusion criteria
Exclusion criteria: 1. Blood sampling not possible; 2. Patient refusal or parent refusal; 3. Not able to comply with scheduled follow-up; 4. Patients with underlying neurological disease such as Charcot-Marie-Tooth disease or Guillain-Barre syndrome; 5. Patients with underlying Down syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic data of vincristine and the active metabolite M1 in peripheral blood. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Serum levels of azoles; 2. Vincristine toxicity will be assessed. | — |
Contacts
Public ContactN.K.A. Eijkelenburg, van
Meibergdreef 9, F8-207
Outcome results
None listed