PRE-emptive therapy of acute Graft Versus Host Disease according to specific proteomic patterns after allogeneic haematopoietic stem cell transplantation
ISRCTN | ISRCTN03911524 |
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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
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 |
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mischak-weissinger.eva@mh-hannover.de |
Study information
Study design | Prospective, double-blinded randomised placebo-controlled multi-centre study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Methylprednisone |
Primary outcome measure | 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 study start date | 01/01/2008 |
Completion date | 31/12/2010 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 580 screening, 260 elegible, 90 randomisation |
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
30625
Germany
Sponsor information
Hannover Medical School (Germany)
Hospital/treatment centre
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 |
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Ganser.Arnold@mh-hannover.de | |
Website | http://www.mh-hannover.de/index.php?id=2&L=1 |
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |