Study on Two Different Formulations of 6-mercaptopurine. Tablet Versus Oral Liquid
Information source: Rigshospitalet, Denmark
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Lymphoblastic Leukemia; 6-mercaptopurine Therapy
Intervention: Xaluprine (Drug); Puri-Nethol (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Kjeld Schmiegelow Official(s) and/or principal investigator(s):
Kjeld Schmiegelow, Professor, Principal Investigator, Affiliation: Pediatric Clinic II, Rigshospitalet, Copenhagen
Summary
Acute lymphoblastic leukemia (ALL) accounts for 30 % of all childhood malignancies. The
patients undergo four phases of treatment, finishing with a late maintenance phase in which
6-mercaptopurine and Methotrexate are essential components. Insufficient treatment intensity
in this phase is associated with increased risk of relapse. Excessive variation in the
bioavailability of 6-mercaptopurine has been observed which can cause both risks of
undertreatment/relapse as well as overtreatment with severe side effects.
In the attempt to achieve individualized 6-mercaptopurine dosing different approaches have
been pursued. Nonetheless variation in bioavailability remains a problem.
Earlier, oral tablets of 50 mg (Purinethol) were the only administration form of
6-mercaptopurine and it was primarily designed for adult patients. Challenges with accurate
dosing and getting the children to swallow the tablets have been a widespread problem,
forcing the caregivers to divide or crush the tablets as well as having to administer
different dosages over 2-3 days. Due to these problems, an oral liquid formulation of
6-mercaptopurine (Xaluprine) has been developed. However this oral liquid has only been
tested on healthy adult volunteers, and not on the target group, childhood patients. This
project will assess the bioavailability and plasma kinetics of oral liquid and tablet
formulation of 6-mercaptopurine in children with acute lymphoblastic leukemia.
The investigators hypothesize to observe comparable plasma kinetics, in children with acute
lymphoblastic leukemia when treated with 6-mercaptopurine in the form of a tablet and oral
liquid formulation, as previously observed in healthy adults.
Clinical Details
Official title: Plasma Kinetics of Tablet and Liquid Formulations of 6-mercaptopurine in Childhood Acute Lymphoblastic Leukemia.
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Time to maximum concentration (Tmax)
Secondary outcome: Area under curve(AUC)Maximum concentration (Cmax) Time to half-life (T½)
Eligibility
Minimum age: N/A.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Childhood acute lymphoblastic leukemia patients, age 0-18 years at diagnosis, treated
at the department of pediatrics and adolescent medicine, Rigshospitalet.
- Informed consent
Exclusion Criteria:
- None
Locations and Contacts
Juliane Marie Centret, Rigshospitalet, Copenhagen, DK- 2100, Denmark; Recruiting
Kjeld Schmiegelow, Professor, Phone: +45 35451357, Email: kjeld.schmiegelow@regionh.dk
Line Gerner, Medical student, Phone: +45 30529488, Email: line.gerner.pedersen.01@hotmail.com
Kjeld Schmiegelow, Professor, Principal Investigator
Line Gerner, Medical Student, Sub-Investigator
Additional Information
Starting date: June 2013
Last updated: March 19, 2015
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