E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute myeloid leukemia (AML) during its first complete remision and with high relapse risk, pre- and post- autologous hematopoiteic transplant |
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MedDRA Classification |
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 effect of the Mylotarg administration in patients with acute myeloid leukemia (AML) during its first complete remision and with high relapse risk, pre- and post- autologous hematopoiteic transplant |
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E.2.2 | Secondary objectives of the trial |
- To evaluate the immediately toxicity due to the Mylotarg administration pre- and post- autologous hematopoiteic transplant - To evaluate the Mylotarg effect about its ability for mobilizing the hematopoitec stem cells from periferic blood and about the post-transplante hematopoietic recovery - To evaluate the Mylotarg effect about the minimum residual disease (MRD) post- consolidation chemotherapy and post-transplant, whereas exits markers, analysed by cytogenetic, inmunophenotipic and molecular methods. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Primary or novo patients with acute myeloid leukemia (AML) different thant M3 subtype or acute promyelocytic myeloid leukemia. - Age > 18 and < 60 years - ECOG PS < 3 - Patients with complete remision after induction and intensification chemotherapy , without extramedular affectation. - Patients would received induction and intensification treatment according to the detailed summary (7. A. 1) - Expression of CD33 by flow cytometri for at least a 20% of the total. - Absence of the HLA-identic sibs - The patient must be recovered from any grade III/IV toxicity of previous chemotherapy treatment (except alopecia). - Consent informed given - Patient must have at least one of the following high risk relapse factors: •cytogenetic alterations, except those that indicate prognosis favourable [t(8;21), inv(16), t(16;16)]. •Normal Cariotype in less that 20 metaphases, or absence of mitosis at diagnosis. •Presence of internal tandem duplication for the FLT3 gen, at diagnosis or at any time during the follow-up •Two induction cycles for reaching the first complete remision •Presence of minimum residual disease (MRD) detectable through CMF (higher than 0,1% of the bone marrow nucleade cells), conventional cariotypeo, FISH or RCP after the intensification detailed in 7.A.1.2.
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E.4 | Principal exclusion criteria |
- Previous autologous or alogenic transplant. - Acute lekemia after a 6 months myeloproliferative process or myelodysplastic syndrome, AML that appears after another cured malignant disease (e.g. Hodgkin disease) and AML due to the treatment with alquilant agents or radiations. - Acute promyelocytic leukemia - Complete remision with more than 2 induction cycles - History of relevant hepatic disease, including occlusive hepatic veno disease during the induction or consolidation treatment - Positive serology for HIV, Hepatitis C or hepatitis B surface antigen. - Active infection at the inclusion in the study. - Life expectancy < 3 months - Pregnancy or Lactation at the inclusion in the study. - Creatinine > 2 mg/dl o bilirrubine > 2 mg/dl, or ALT o AST < 2 x UNL |
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E.5 End points |
E.5.1 | Primary end point(s) |
Leukemia relapse frequencies pre- and post- autologous trasplant of hematopoitec stem cells (historic control) |
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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 | 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 | Information not present in EudraCT |
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 | 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 | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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.8.5 | 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 | Information not present in EudraCT |
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
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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 | 0 |
E.8.9.1 | In the Member State concerned days | |