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ISRCTN
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ISRCTN03911524
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ClinicalTrials.gov identifier
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Public title
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PRE-emptive therapy of acute Graft Versus Host Disease according to specific proteomic patterns after allogeneic haematopoietic stem cell transplantation
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Scientific title
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Acronym
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PRE-GVHD
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Serial number at source
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497Ganser_Weissinger
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Study hypothesis
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Reduction of both severity and/or incidence of acute graft versus host disease (aGvHD) greater than grade II in the pre-emptively treated population as compared to placebo treated group.
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Ethics approval
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The collection/analysis of residual material as used in this study has already been approved by the Ethics Committee of the Hannover Medical School in November 2002 and November 2005 (ref: 3097).
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Study design
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Prospective, double-blinded randomised placebo-controlled multi-centre study
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Graft versus host disease after allogeneic haematopoietic stem cell transplantation
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Participants - inclusion criteria
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1. All patients greater than 18 years after allogeneic haematopoietic stem cell transplantation (allo-HSCT)
2. Informed consent
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Participants - exclusion criteria
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1. Severe infections at the time of aGvHD-pattern positivity
2. No informed consent
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Anticipated start date
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01/01/2008
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Anticipated end date
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31/12/2010
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Status of trial
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Ongoing |
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Patient information material
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Target number of participants
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580 screening, 260 elegible, 90 randomisation
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Interventions
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Experimental intervention:
Pre-emptive immunosuppressive treatment (daily 2 mg methylprednisone/kg body weight [BW]) immediately at occurrence of an aGvHD grade II-specific proteome pattern.
Control intervention:
Placebo immediately at occurrence of a positive aGvHD grade II-specific proteome pattern.
Duration of intervention per patient:
2 mg/kg/kg BW steroids for five days if no clinical symptoms occur (taper steroids according to taper protocol), or until severity increases (clinical symptoms of aGvHD grade II; increase of symptoms in severity after three days, no change for seven days, intermediate response for 14 days).
In case of clinical aGvHD (greater than grade II) unblinding is necessary: the placebo group will start standard treatment with 2 mg methylprednisone/kg BW, treatment group will be open for second line therapy (e.g. 2 mg methylprednisone/kg BW and Antithymocyte Globulin (ATG) or clinic specific second line therapy).
Experimental and/or control off label or on label in Germany: not applicable.
Follow-up per patient: 100 days after HSCT.
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Primary outcome measure(s)
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Occurrence of aGvHD (greater than grade II) in placebo versus treatment group, between time of randomisation and 100 days after HSCT.
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Secondary outcome measure(s)
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1. Increased overall survival in treatment group (day +365)
2. Reduction of severity of aGvHD (day +120)
Scientific endpoints (measured at end of study: three years):
1. Differentiation of aGvHD grade II to IV according to polypeptide markers
2. Organ specific aGvHD pattern
3. Generation of proteomic patterns for steroid resistant GvHD (will be acquired during the study)
4. Normalisation of aGvHD proteome pattern in response to treatment
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Sources of funding
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German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany) (ref: 497Gasnser_Weissinger)
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Trial website
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Publications
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Contact name
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Prof
Eva M.
Mischak-Weissingger
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Address
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Hannover Medical School
Department of Haematology, Haemostasis, Oncology and Stem Cell Transplantation
Carl-Neuberg-Str. 1
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City/town
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Hannover
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Zip/Postcode
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30625
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Country
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Germany
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Tel
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+49 (0)511 532 9518
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Fax
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+49 (0)511 532 6843
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Email
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mischak-weissinger.eva@mh-hannover.de
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Sponsor
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Hannover Medical School (Germany)
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Address
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c/o Prof. Dr. med. Arnold Ganser
Director
Department of Haematology, Haemostasis, Oncology and Stem Cell Transplantation
Carl-Neuberg-Str. 1
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City/town
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Hannover
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Zip/Postcode
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30625
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Country
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Germany
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Tel
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+49 (0)511 532 3021
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Fax
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+49 (0)511 532 8041
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Email
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Ganser.Arnold@mh-hannover.de
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Sponsor website:
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http://www.mh-hannover.de/index.php?id=2&L=1
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Date applied
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27/06/2007
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Last edited
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02/09/2008
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Date ISRCTN assigned
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19/12/2007
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