The aim of this study is to improve 6MP treatment in pediatric leukemia patients, by developing and licensing a pediatric liquid formulation of 6MP, assessing its stability and bioequivalence, and ensuring a nationwide introduction of the new…
ID
Source
Brief title
Condition
- Leukaemias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 by
questionnaires.
Secondary outcome
Acceptation by the patient
Background summary
Patients with acute lymphoblastic leukemia (ALL) are currently treated in the
Netherlands according to the Dutch Childhood Oncology Group (DCOG) ALL10
protocol, in which the oral cytotoxic drug 6-mercaptopurine (6MP) is
administered daily, for a period between one and two years. Because of the lack
of a commercially available pediatric formulation of 6MP, 6MP needs to be
prepared as capsules containing the specific dosage needed for each patient by
community pharmacies. Every 2 weeks the dosage of 6MP is adapted according to
the leukocytes count. Since most pharmacies are not equipped to prepare
capsules of cytotoxic compounds such as 6MP, the availability (within an
acceptable time-window) of 6MP in the correct dosage, after discharge of the
patient and after every dosage adaptation, is problematic and may lead to
inadequate patient care. Moreover, in order to prepare a drinking solution for
younger children, the parents have to dissolve the capsules at home with water
before administration. This may lead to unwanted drug exposure of the parents,
and may also increase the risk for errors in dosing or administration.
Study objective
The aim of this study is to improve 6MP treatment in pediatric leukemia
patients, by developing and licensing a pediatric liquid formulation of 6MP,
assessing its stability and bioequivalence, and ensuring a nationwide
introduction of the new formulation.
Study design
A crossover open label study will be performed.
Intervention
Patients will receive 4 weeks treatment with capsules, followed by 4 weeks
treatment with liquid formulation, or vice versa.
Study burden and risks
The burden and risks for the patients are minimal. Every patient will receive
6MP as part of standard clinical care. Blood sampling will be done using the
existing vascular access ports, during regular hospital visits. A diary has to
be filled in during the study period to record side effects and compliance
issues.
The study needs to be performed in this patient population, because of the
established indication for 6MP in pediatric leukemia and the problems
associated with drug formulations in children.
dr molewaterplein 60
3015 gd rotterdam
NL
dr molewaterplein 60
3015 gd rotterdam
NL
Listed location countries
Age
Inclusion criteria
- histologically or cytologically confirmed acute lymphatic leukemia
- inclusion in dcog all10 protocol or interfant 06
- available venous access port
- ALAT and ASAT <1000 IU/l
- written informed consent
Exclusion criteria
- patient or parent refusal
- pre-existing liver disease
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-000424-86-NL |
| CCMO | NL21347.078.08 |