Development and introduction of a pediatric liquid formulation of 6-mercaptopurine for treatment of leukemia.
- Conditions
- acute lymphoblastic leukemia in pediatric patientsacute lymfatische leukemie bij kinderen
- Registration Number
- NL-OMON20904
- Lead Sponsor
- Erasmus MCHospital Pharmacy and Pediatric Oncology
- Brief Summary
ALL-10 study protocol, the Dutch Childhood Oncology Group. Principal investigator: Prof.dr. Rob Pieters.<br> INTERFANT-06. International collaborative treatment protocol for infants under one year of age with acute lymphoblastic or biphenotypic leukemia. Dutch Childhood Oncology Group, Principal investigator: Prof.dr. Rob Pieters.<br> B.A. Bell et al. A comparison of red blood cell thiopurine metabolites in children with acute lymphoblastic leukemia who received oral mercaptopurine twice daily or once daily: A Pediatric Oncology Group study (now The Children's Oncology Group). Pediatr Blood Cancer 2004;43(2):105-9 <br> F Innocenti et al. Variable correlation between 6-mercaptopurine metabolites in erythrocytes and haematological toxicity; implications for drug monitoring in children with acute lymphoblastic leukemia. Ther Drug Monit 2000; 22(4): 375-382. <br> Balis FM et al. Pharmacokinetics and pharmacodynamics of oral methotrexate and mercaptopurine in children with lower risk acute lymphoblastic leukemia; a joint children’s cancer group and pediatric oncology branch study, Blood 1998 (92); 3569-3577<br> Chrzanowska M, Kolecki P, Duczmal-Cichocka B, Fiet J. Metabolites of mercaptopurine in red blood cells: a relationship between 6-thioguanine nucleotides and 6-methylmercaptopurine metabolite concentrations in children with lymphoblastic leukemia Eur J Pharm Sci.1999; 8(4):329-34.<br> Lennard L, Keen D, Lilleyman JS. Oral 6-mercaptopurine in childhood leukemia: parent drug pharmacokinetics and active metabolite concentrations. Clin Pharmacol Ther. 198640(3):287-92. <br> EMEA Note for guidance on the investigation of bioequivalence and bioequivalence (2001 cpmp/ewp/qwp/1401/98)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
1. Histologically or cytologically confirmed diagnosis of ALL;
2. Inclusion in DCOG ALL-10 or Interfant-06 protocol;
1. Patient refusal or parent refusal;
2. Patients with pre-existing liver disease;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.