E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Nueroblastoma (Nb) Enfermos afectos de Nb de alto riesgo (Nb estadio 4 mayores de 1 año y Nb estadios 2, 3, 4 con amplificación N-myc). Neuroblastoma (Nb) patients with high risk neuroblastoma (stage 4 Nb in children over one year, stages 2, 3 and 4 with N-myc amplification) |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029260 |
E.1.2 | Term | Neuroblastoma |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10029260 |
|
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 |
Demostrar si la adición del anticuerpo ch14.18 al ácido 13-cis retinoico mejpra la SLE (supervivencia libre de enfermedad) a 3 años en pacientes con Neuroblastoma de Alto Riesgo |
|
E.2.2 | Secondary objectives of the trial |
Determinar la tolerancia del ácido 13-cis retinoico tras el trasplante con y sin la adición de inmunoterapia con el anticuerpo monoclonal quimérico recombinante ch14.18 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Pacientes incluidos en el Estudio de Neuroblastoma de Alto Riesgo que tengan firmado el consentimiento informado para R2 y que cumplen con los criterios de inclusión para R2 (participación en R1, o lactantes con amplificación de N-myc y Bumel electivo, reestadiaje completo de la enfermedad tras el trasplante, recuperación de toxicidades mayores relacionadas con el mismo y finalización de la radioterapia local. Buen estado de salud y sin signos clínicos y analíticos de infección) |
|
E.4 | Principal exclusion criteria |
Cualquier respuesta negativa a los criterios de inclusión detallados en E3 será motivo de exclusión |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Estadio, Amplificación de N-myc, Edad |
|
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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
ácido 13-cis retinoico solo (estandard) frente a ácido 13-cis retinoico + anticuerpo ch14.18 |
|
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 24 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
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
|
La recomendación de cerrar o continuar el ensayo es de carácter médico debiendose utilizar las reglas de interrupción como pautas. Si un valor p cae por debajo de los umbrales específicos, los análisis interinos serán discutidos por el Trial Management Committe (TMC). La decisión final o recomendación de modificar o terminar la inclusión es responsable del TMC. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 7 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |