E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients suffering from leukemia (acute or chronic), receiving allogenic blood stem cell transplantation |
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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 observe the incidence of grade 3 and 4 (WHO) mucositis with or without application of kepivance |
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E.2.2 | Secondary objectives of the trial |
To observe -the incidence of the ulcerative mucositis (WHO grade 2-4) -duration of WHO grade 3 and 4 mucositis -process of the cellular T-cell reconstitution after transplantation -supportive care necessary (blood cell substitute, pain therapy (opioids necessary), parenteral nutrition -grade and extnt of the acute graft-versus-host disease -interaction with drug-induced immunsupression -rate of infections (number of days with fever, antibiotics needed) -therapy-induced mortalitiy day+100 -number of relapses +360 days after steem cell transplantation -median times to granulocyte engraftment > 1000/µl, to platelet engraftment > 20000/µl and > 50000/µl -rate and duration of febrile episodes -duration of hospitalisation |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-age >= 18 years -general condition ECOG WHO <=2 -life expectancy over three months -total body irradiation with 10 to 12 Gy total body dosis with a lung dosis of 8 Gy fractionated, in combination with high dose chemotherapy (120 mg/kg body weight cyclophosphamid i.v.)and optional for unrelated donors administration of antithymocyte globulin before application of the graft -allogeneic stem cell transplantation (bone marrow or blood stem cells) with al HLA-compatible donor with a minimum of 8 out of 10 compatible HLA-class-I (A,B,C) or -II (DR,DQ) compatibility -acute or chronic leukemia with an indication for an allogenic stem cell transplantation -graft-versus-host prophylaxis with cyclosporin A or tacrolismus in a combination with or without mycophenolat or methotrexat -women of childbearing potential must us an high effictive method for contraception -negativ pregnancy test -signed informed consent of the patient
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E.4 | Principal exclusion criteria |
-contraindication for allogenic stem cell transplantation -dose-reduced conditioning with <= 8 Gy total body irradation dose -haploid stem cell donor -pregnant or lactating women -women of childbearing potential not using a high effective method for contraception -pre-medication with palifermin -hypersensitivity against palifermin, one of its contents or proteins derived from eschericia coli -no signed informed consent of the patient |
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E.5 End points |
E.5.1 | Primary end point(s) |
-incidence of grade 3 and 4 (WHO) mucositis |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
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) | 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 | 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 |
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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 | 7 |
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 | 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
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |