acute lymphoblastic leukemia
Conditions
Interventions
Patients will receive 4 weeks treatment with capsules, followed by 4 weeks
treatment with liquid formulation, or vice versa.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: - histologically or cytologically confirmed acute lymphatic leukemia - inclusion in dcog all10 protocol or interfant 06 - available venous access port - ALAT and ASAT
Exclusion criteria
Exclusion criteria: - patient or parent refusal - pre-existing liver disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bioequivalence will be assessed by determining blood levels of the active metabolites of 6MP in red blood cells. Two-weekly leukocyte counts will be performed to monitor hematological toxicity. Compliance and acceptance of the different formulations by children and parents will be assessed by questionnaires. | — |
Secondary
| Measure | Time frame |
|---|---|
| Acceptation by the patient | — |
Countries
Netherlands
Outcome results
None listed