Development and introduction of a pediatric liquid formulation of 6-mercaptopurine for treatment of leukemia - 6MP formulatio

Conditions: Acute lymphoblastic leukemia
MedDRA version: 9.1Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemia

Registration Number: EUCTR2008-000424-86-NL

Lead Sponsor: Erasmus MC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

-Patient refusal or parent refusal
-Patients with pre-existing liver disease
-Other serious illnesses or medical conditions

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>- 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

Secondary Outcome Measures