E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Elderly patients (61-75 years not eligible for intensive chemotherapy;age > 75 years), with previously untreated, primary or secondary (no after other myeloproliferative diseases) AML (except M3). |
LEUCEMIA ACUTA MIELOIDE (non M3)in pazienti anziani(61-75 aa non eleggibili per la chemioter. intensiva o che la rifiutino;pazienti eta'>75 aa), primaria o secondaria(ma non ad altre malattie mieloproliferative), non precedentemente trattata. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
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 | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
PHASE II:to assess the feasibility, toxicity profile and antileukemic activity of two different regimens of Gemtuzumab Ozogamicin (GO) monotherapy as induction treatment in the study population. PHASE III: to prospectively compare, in terms of overall survival, the efficacy and toxicity of GO monotherapy (best induction regimen, selected after phase II, followed by a maximum of 8 fourweekly pulses of low dose GO as continuation therapy) versus standard supportive care. The main endpoint will be the duration of survival. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria | |
E.4 | Principal exclusion criteria | |
E.5 End points |
E.5.1 | Primary end point(s) |
PRIMARY PHASE II:For each of the two investigational arms (A and B): proportion of patients able to start continuation therapy with gemtuzumab. PHASE III:Overall survival. SECONDARY PHASE II:Rate of complete remission (CR+CRp) by the end of induction therapy, for patients in GO arms.Toxicity (CTCAE grading), including time to hematological recovery.Overall survival PHASE III: Rate of complete remission (CR+CRp) by the end of induction and by the end of continuation therapy, for patients in GO arm.Disease-free survival for patients who reached CR or CRp. Progression-free survival from randomization for patients in GO arm. Toxicity (CTCAE grading), including time to hematological recovery. |
|
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 | 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 | Yes |
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 | 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 |
Standard supportive care - Stesso farmaco ad altro dosaggio |
- same IMP used at different dosage |
|
E.8.2.4 | Number of treatment arms in the trial | 5 |
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 | 48 |
E.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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 | 6 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |