Condition category
Injury, Occupational Diseases, Poisoning
Date applied
27/06/2007
Date assigned
19/12/2007
Last edited
02/09/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.mh-hannover.de/index.php?id=2&L=1

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

Publication citations

Additional files

Editorial Notes