PRE-emptive therapy of acute Graft Versus Host Disease according to specific proteomic patterns after allogeneic haematopoietic stem cell transplantation

ISRCTN	ISRCTN03911524
DOI	https://doi.org/10.1186/ISRCTN03911524
Protocol serial number	497Ganser_Weissinger
Sponsor	Hannover Medical School (Germany)
Funder	German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany) (ref: 497Gasnser_Weissinger)

Submission date: 27/06/2007
Registration date: 19/12/2007
Last edited: 02/09/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Eva M. Mischak-Weissingger
Scientific

Hannover Medical School
Department of Haematology, Haemostasis, Oncology and Stem Cell Transplantation
Carl-Neuberg-Str. 1
Hannover
30625
Germany

Phone	+49 (0)511 532 9518
Email	mischak-weissinger.eva@mh-hannover.de

Study information

Primary study design	Interventional
Study design	Prospective, double-blinded randomised placebo-controlled multi-centre study
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	PRE-GVHD
Study objectives	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(s)	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).
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Methylprednisone
Primary outcome measure(s)	Occurrence of aGvHD (greater than grade II) in placebo versus treatment group, between time of randomisation and 100 days after HSCT.
Key secondary outcome measure(s)	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
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	580
Key inclusion criteria	1. All patients greater than 18 years after allogeneic haematopoietic stem cell transplantation (allo-HSCT) 2. Informed consent
Key exclusion criteria	1. Severe infections at the time of aGvHD-pattern positivity 2. No informed consent
Date of first enrolment	01/01/2008
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

Germany

Study participating centre

Hannover Medical School

Hannover
30625
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan