Vincristine and concomitant azole therapy in pediatric acute lymphoblastic leukemia patients - a pharmacokinetic study

Vincristine and concomitant azole therapy in pediatric acute lymphoblastic leukemia patients - a pharmacokinetic study - VCR-Azole study

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON35826

Enrollment

Registered

2011-10-26

Start date

2012-02-07

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute lymphoblastic leukemia - cancer of white blood cells

Interventions

None listed

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: - 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 -

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
Blood levels of vincristine and the metabolite, M1 will be analyzed after administration of vincristine.	—

Secondary

Measure	Time frame
Blood levels of the azoles will be analyzed at the same time. One whole blood sample for DNA extraction and genotyping will be collected from each patient enrolled in this study. Furthermore, we will study toxicity.	—

Countries

Netherlands

Outcome results