acute lymphoblastic leukemia in pediatric patients acute lymfatische leukemie bij kinderen
Conditions
Interventions
Patients will be randomized to receive 4 weeks 50 mg/m2 /day 6MP as a capsule and subsequently 4 weeks the same dosage of 6MP as a liquid drinking solution, or vice versa. Patients will participate in
Sponsors
Erasmus MC
Hospital Pharmacy and Pediatric Oncology
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed diagnosis of ALL; 2. Inclusion in DCOG ALL-10 or Interfant-06 protocol; 3. Recovered from acute side-effects of previous treatment blocks; 4. Lansky play score > 60; or Karnofsky performance status > 60; 5. Normal liver function defined as less than or equal to NCI-CTG grade 1 (max 2.5 x ULN for transaminases and bilirubin); 6. Able to comply with scheduled follow-up and with management of toxicity; 7. Age 1 month-18 years; 8. Available venous access port; 9. 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. Patient refusal or parent refusal; 2. Patients with pre-existing liver disease; 3. Other serious illnesses or medical conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood levels of the metabolites of 6MP will be analyzed after administration of the two different formulations, in order to establish the bio-equivalence of the liquid formulation compared to the capsules. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactL. Hanff
Outcome results
None listed