Contact information
Type
Scientific
Primary contact
Prof Eva M. Mischak-Weissingger
ORCID ID
Contact details
Hannover Medical School
Department of Haematology
Haemostasis
Oncology and Stem Cell Transplantation
Carl-Neuberg-Str. 1
Hannover
30625
Germany
+49 (0)511 532 9518
mischak-weissinger.eva@mh-hannover.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
497Ganser_Weissinger
Study information
Scientific title
Acronym
PRE-GVHD
Study hypothesis
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.
Ethics approval
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).
Study design
Prospective, double-blinded randomised placebo-controlled multi-centre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Graft versus host disease after allogeneic haematopoietic stem cell transplantation
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Methylprednisone
Primary outcome measures
Occurrence of aGvHD (greater than grade II) in placebo versus treatment group, between time of randomisation and 100 days after HSCT.
Secondary outcome measures
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
Overall trial start date
01/01/2008
Overall trial end date
31/12/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. All patients greater than 18 years after allogeneic haematopoietic stem cell transplantation (allo-HSCT)
2. Informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
580 screening, 260 elegible, 90 randomisation
Participant exclusion criteria
1. Severe infections at the time of aGvHD-pattern positivity
2. No informed consent
Recruitment start date
01/01/2008
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Germany
Trial participating centre
Hannover Medical School
Hannover
30625
Germany
Sponsor information
Organisation
Hannover Medical School (Germany)
Sponsor details
c/o Prof. Dr. med. Arnold Ganser
Director
Department of Haematology
Haemostasis
Oncology and Stem Cell Transplantation
Carl-Neuberg-Str. 1
Hannover
30625
Germany
+49 (0)511 532 3021
Ganser.Arnold@mh-hannover.de
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany) (ref: 497Gasnser_Weissinger)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary