E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Untreated patients aged 60> years with Acute Myeloid Leukemia |
Pazienti affetti da Leucemia Acuta Mieloide non precedentemente trattati di eta' maggiore di 60 anni |
|
E.1.1.1 | Medical condition in easily understood language |
Acute Myeloid Leukemia |
Leucemia Acuta Mieloide |
|
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 | 15.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10000880 |
E.1.2 | Term | Acute 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 assess the complete remission (CR)rate of the combination regimen low dose ARA-C + Tosedostat |
Valutare il tasso di remissione completa (CR) del regime di combinazione Citarabina a basse dosi + Tosedostat |
|
E.2.2 | Secondary objectives of the trial |
To determine the safety and toxicity of the combination regimen. To determine response rate of stable disease or better. To determine the relationship of single cytogenetic abnormalities with response to treatment. To determine the overall and progression-free survival of patients completing the treatment |
Determinare la sicurezza e la tossicita' della combinazione terapeutica.Determinare il tasso di risposta come malattia stabile o in miglioramento.Determinare la relazione tra le singole anomalie citogenetiche e la risposta al trattamento.Determinare la sopravvivenza totale e la sopravvivenza libera da progressione nei pazienti che completano il trattamento. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male and female patients aged > 60 years Signed informed consent Morphologically confirmed diagnosis of acute myeloid leukemia by bone marrow aspiration within the past 14 days |
Pazienti maschi e femmine di eta' maggiore di 60 anni Consenso informato scritto Diagnosi di leucemia acuta mieloide confermata morfologicamente con aspirato midollare nei 14 giorni precedenti l'arruolamento nello studio. |
|
E.4 | Principal exclusion criteria |
HIV infection HCV positivity Active second malignancy Diagnosis of relapsed acute promyelocitic leukemia |
Infezione da HIV Positivita' HCV Patologia neoplastica secondaria attiva Diagnosi di recidiva di leucemia promielocitica acuta |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To assess the complete remission (CR)rate of the combination regimen low dose ARA-C + Tosedostat |
Valutare il tasso di remissione completa (CR) del regime di combinazione Citarabina a basse dosi + Tosedostat |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
First time point: 2 months after the start of therapy. Subsequent time points: every 2 months, by bone marrow biopsy. |
Prima rilevazione: 2 mesi dopo l'inizio della terapia. Rilevazioni successive: ogni 2 mesi, mediante biopsia midollare. |
|
E.5.2 | Secondary end point(s) |
To determine the safety and toxicity of the combination regimen To determine response rate of stable disease or better To determine the overall and progression-free survival |
Determinare la sicurezza e la tossicita' della combinazione terapeutica Determinare il tasso di risposta Determinare la sopravvivenza totale e la sopravvivenza libera da progressione |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Last patient, last visit. |
Ultimo paziente, ultima visita. |
|
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 | 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 | Yes |
E.8.1.1 | Randomised | No |
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 | 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 |
terapia convenzionale |
standard regimen |
|
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 | 6 |
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
|
|
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 |