E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
acute lymphoblastic and myeloid leukemia |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10024330 |
E.1.2 | Term | Leukemia acute |
|
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 |
The study should demonstrate that the use of ATG FRESENIUS will reduce the risk of chronic graft-versus-host disease after allogeneic stem cell transplantation from HLA-identical sibling. |
|
E.2.2 | Secondary objectives of the trial |
Secondary objectives :· Comparison of acute graft-versus-host disease on day +100 after stem cell transplantation according to the acc. to the Glucksberg scale · Comparison of quality of life between both treatment arms according to the EORTC. Comparison of treatment-related mortality on day +100 and day +365 after allogeneic peripheral blood stem cell transplantation. Comparison of toxicity according to the Bearman-Score. Comparison of overall survival post-transplant at two years.· Comparison of progression-free survival post-transplant at two years.· Comparison of engraftment (leukocyte count > 1.0 x 109/l, platelet count > 20 x x 109/l). Comparison of incidence of bacterial, viral, fungal and protozoal infection at day +100 and at one year after transplantation. Comparison of chronic-GvHD-free survival between the two treatment arms at two years. Incidence of adverse events (AEs) and adverse drug reactions (ADRs) between the two treatment arms. |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Analysis of genetic polymorphism of the gene NOD2/CARD15 and KIR-genes and related genes to predict graft-versus-host disease and transplant-associated complications |
|
E.3 | Principal inclusion criteria |
Acute myeloid leukemia in first or subsequent complete remission (de-novo or secondary AML). Acute lymphoblastic leukemia in first or subsequent complete remission. Patient's age: 18 – 65 years. Myeloablative standard conditioning. HLA-identical sibling (HLA-A, HLA-B, HLA-DRB1 and HLA-DQB1). No major organ dysfunctions. Patient's written informed consent |
|
E.4 | Principal exclusion criteria |
No complete remission at time of randomization. Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as o Total bilirubin, SGPT or SGOT > 5 times upper the normal level. o Left ventricular ejection fraction < 30 %. o Creatinine clearance < 30 ml/min. o DLCO < 35 % and/or receiving supplementary continuous oxygen. Positive serology for HIV. Pregnant or lactating women. Serious psychiatric or psychological disorders. Progressive invasive fungal infection at time of registration |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Comparison of cumulative incidence of chronic GvHD (limited or extensive) after allogeneic peripheral blood stem cell transplantation from HLA-identical siblings with or without anti-T-lymphocyte-globulin according to the revised Seattle criteria of Lee et al. and of the NIH Consensus Development Project at two years after transplantation. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
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 | 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) | 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 |
Standard GvHD Prophylaxis |
|
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 31 |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
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 | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |