E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute myeloid leukemia in first or subsequent complete remission |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10024291 |
E.1.2 | Term | Leukaemias acute myeloid |
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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 present study will be a multicenter, prospective phase III-study comparing ATG versus no-ATG within the myeloablative conditioning regimen followed by allogeneic peripheral blood stem cell transplantation from HLA-identical siblings in patients with acute leukemia. The study should demonstrate that the use of ATG will reduce the risk of chronic graftversus- host disease after allogeneic stem cell transplantation from HLA-identical sibling. |
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E.2.2 | Secondary objectives of the trial |
Comparison of acute graft-versus-host disease on day +100 after stem cell transplantation according to the acc. to the Glucksberg scale [26] Comparison of quality of life between both treatment arms according to the EORTC (also see section 0 on page 28ff). 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 [27] (Appendix 1.37 on page 44). 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. |
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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 |
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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. |
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E.4 | Principal exclusion criteria |
No complete remission at time of randomization. Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as Total bilirubin, SGPT or SGOT > 5 times upper the normal level. Left ventricular ejection fraction < 30 %. Creatinine clearance < 30 ml/min. DLCO < 35 % and/or receiving supplementary continuous oxygen. Positive serology for HIV. |
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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 antithymocyte globulin according to the revised Seattle criteria of Lee et al. |
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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 | No |
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 | Information not present in EudraCT |
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 |
Investigational Medicinal Product vs Non-Investigational Medicinal Product |
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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 | 20 |
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 | Information not present in EudraCT |
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 | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
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 |