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
Secondary identifying numbers 497Ganser_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

Study designProspective, double-blinded randomised placebo-controlled multi-centre study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymPRE-GVHD
Study objectivesReduction 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) studiedGraft versus host disease after allogeneic haematopoietic stem cell transplantation
InterventionExperimental 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Methylprednisone
Primary outcome measureOccurrence of aGvHD (greater than grade II) in placebo versus treatment group, between time of randomisation and 100 days after HSCT.
Secondary outcome measures1. 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 study start date01/01/2008
Completion date31/12/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants580 screening, 260 elegible, 90 randomisation
Key inclusion criteria1. All patients greater than 18 years after allogeneic haematopoietic stem cell transplantation (allo-HSCT)
2. Informed consent
Key exclusion criteria1. Severe infections at the time of aGvHD-pattern positivity
2. No informed consent
Date of first enrolment01/01/2008
Date of final enrolment31/12/2010

Locations

Countries of recruitment

  • Germany

Study participating centre

Hannover Medical School
Hannover
30625
Germany

Sponsor information

Hannover Medical School (Germany)
Hospital/treatment centre

c/o Prof. Dr. med. Arnold Ganser
Director
Department of Haematology, Haemostasis, Oncology and Stem Cell Transplantation
Carl-Neuberg-Str. 1
Hannover
30625
Germany

Phone +49 (0)511 532 3021
Email Ganser.Arnold@mh-hannover.de
Website http://www.mh-hannover.de/index.php?id=2&L=1
ROR logo "ROR" https://ror.org/00f2yqf98

Funders

Funder type

Government

German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany) (ref: 497Gasnser_Weissinger)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan