E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic myeloid leukemia |
Leucemia mieloide cronica |
|
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 | 10052065 |
E.1.2 | Term | Chronic phase chronic myeloid leukaemia |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
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 |
To evaluate the frequency of the polimorfisms of the genes involved in the intracellular uptake of Nilotinib in
caucasian patients. |
Stabilire la frequenza delle polimorfismi dei geni coinvolti nel trasporto intracellulare di Nilotinib in pazienti di razza caucasica. |
|
E.2.2 | Secondary objectives of the trial |
1) To establish a possible association between the polimorfisms of the genes involved in the intracellular uptake
of Nilotinib and the pathogenesis and progression of chronic myeloid leukemia.
2) To establish a possible association between the polimorfisms of the genes involved in the intracellular uptake
of Nilotinib and the clinical evolution of chronic myeloid leukemia |
1) Stabilire l’associazione tra i polimorfismi dei geni di trasporto e fattori biologici coinvolti nella patogenesi e nella progressione della leucemia mieloide cronica
2)Stabilire l’associazione tra i polimorfismi dei geni di trasporto e l’evoluzione clinica della malattia. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Aged > 18 years.
Signed informed consent.
Diagnosis of chronic myeloid leukemia. |
Diagnosi di leucemia mieloide cronica; Consenso informato scritto firmato; eta' > 18 anni. |
|
E.4 | Principal exclusion criteria |
Aged < 18 years.
No signed informed consent.
Diagnosis of any other form of leukemia except from chronic myeloid leukemia.
E. |
eta' < 18 anni. Assenza di consenso informato scritto. Diagnosi di altre forme di leucemia che non siano una leucemia mieloide cronica. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate the frequency of polimorfisms of the genes involved in intracellular uptake in the caucasian
population |
Stabilire la frequenza delle polimorfismi dei geni coinvolti nel trasporto intracellulare di Nilotinib in pazienti di razza caucasica. |
|
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 | 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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 15 |
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 | No |
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
|
ultima visita dell'ultimo soggetto inserito nella sperimentazione |
|
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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |