E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Childhood acute lymphoblastic leukemia. |
Akut lymphoblastær leukæmi hos børn |
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E.1.1.1 | Medical condition in easily understood language |
Blood cancer in children |
Blod kræft hos børn |
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E.1.1.2 | Therapeutic area | Diseases [C] - Blood and lymphatic diseases [C15] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000845 |
E.1.2 | Term | Acute lymphoblastic leukemia |
E.1.2 | System Organ Class | 100000004864 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main objective of this trial in to investigate whether previous findings, from a trial conducted on healthy adults regarding plasma kinetics and bioavailability of tablet (Puri-Nethol) and oral liquid formulation (Xaluprine) of 6-mercaptopurine, is similar in the target population, children with ALL. |
Formålet med projektet er at undersøge hvorvidt plasmakinetikken og biotilgængeligheden af tablet (Puri-Nethol) og flydende form (Xaluprine) af 6-mercaptopurin er den samme hos målgruppen, børn med ALL, som ved et tidligere studie, udført på raske voksne. |
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E.2.2 | Secondary objectives of the trial |
As a secondary objectiv, we want to investigate the intra-individual (within each patient) variability upon successive doses of 6-mercaptopurine, since it has been suggested in a trial on healty adult volunteers, that the oral liquid formulation exhibits less intra-individual variation, compared to the tablet formulation. |
Som et sekundært mål, vil vi undersøge den intra-individuelle (indenfor hver patient) variabilitet mellem flere på hinanden følgende doseringer af 6-mercaptopurin. Det har været antydet i et studie lavet på raske voksne forsøgspersoner, at der ses mindre intra-individuel variation ved dosering med den flydenden form, sammenlignet med tablet formen. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Childhood acute lymphoblastic leukemia patients, age 0-18 years at diagnosis. Treated at department of pediatrics and adolescent medicin, Rigshospitalet, Copenhagen. |
Børn med akut lymphoblastær leukæmi, i alderen 0-18 på diagnose tidspunktet, som behandles på BørneUngeKlinikken, Rigshospitalet, København. |
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E.4 | Principal exclusion criteria |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end-point is Tmax (time to maximum concentration). |
Det primær endepunkt er Tmax (tid til maksimal koncentration). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The Tmax will be evaluated continuously, as the laboratory analysis are being conducted. |
Tmax vil blive evalueret løbende, som laboratorie analyserne bliver udført. |
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E.5.2 | Secondary end point(s) |
The secondary end points is Cmax, AUC, t½ |
De sekundære endepunkter er Cmax, AUC, t½ |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The secundary endpoints will be evaluated continuously, as the laboratory analysis are being conducted. |
De sekundære endepunkter vil blive evalueret løbende, som laboratorie analyserne bliver udført. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Yes |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The trial will end two years after inclusion of the first trial subject. This is due to the fact that the laboratory analysis will be done after inclusion of all the trial subjects. |
Forsøget vil blive afsluttet to år efter inklusion af først forsøgsperson. Dette skyldes at laboratorie analyserne vil blive udført efter inklusion af alle forsøgsdeltagerne. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |