Acute lymphoblastic leukemia MedDRA version: 9.1 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia
Conditions
Interventions
Product Name: 6-mercaptopurine
Pharmaceutical Form: Capsule*
Product Name: 6-mercaptopurine
Pharmaceutical Form: Oral suspension
Trade Name: Puri-Nethol
Product Code: 6-mercaptopurine
Pharmaceutical
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically or cytologically confirmed diagnosis of ALL - Inclusion in DCOG ALL-10 or Interfant-06 protocol - Recovered from acute side-effects of previous treatment blocks - Lansky play score > 60; or Karnofsky performance status > 60 - Normal liver function defined as less than or equal to NCI-CTG grade 1 (max 2.5 x ULN for transaminases and bilirubin) - Able to comply with scheduled follow-up and with management of toxicity - Age 1 month-18 years - Available venous access port - Written informed consent from patients or from parents or legal guardians for minor patients, according to local law and regulations Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patient refusal or parent refusal - Patients with pre-existing liver disease - Other serious illnesses or medical conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To improve 6MP treatment in pediatric leukemic patients by developing a pediatric liquid formulation of 6MP and assessing its bioequivalence.;Secondary Objective: - to improve the compliance by using a formulation developed for children - to minimize medication errors and improve availsbility and pharmaceutical quality of a pediatric 6mp formulation;Primary end point(s): 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 | — |
Countries
Netherlands
Outcome results
None listed