PRE-emptive therapy of acute Graft Versus Host Disease according to specific proteomic patterns after allogeneic haematopoietic stem cell transplantatio
Completed
- Conditions
- Graft versus host disease after allogeneic haematopoietic stem cell transplantationInjury, Occupational Diseases, PoisoningFailure and rejection of transplanted organs and tissues
- Registration Number
- ISRCTN03911524
- Lead Sponsor
- Hannover Medical School (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 580
Inclusion Criteria
1. All patients greater than 18 years after allogeneic haematopoietic stem cell transplantation (allo-HSCT)
2. Informed consent
Exclusion Criteria
1. Severe infections at the time of aGvHD-pattern positivity
2. No informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of aGvHD (greater than grade II) in placebo versus treatment group, between time of randomisation and 100 days after HSCT.
- Secondary Outcome Measures
Name Time Method 1. Increased overall survival in treatment group (day +365)<br>2. Reduction of severity of aGvHD (day +120)<br><br>Scientific endpoints (measured at end of study: three years): <br>1. Differentiation of aGvHD grade II to IV according to polypeptide markers<br>2. Organ specific aGvHD pattern<br>3. Generation of proteomic patterns for steroid resistant GvHD (will be acquired during the study)<br>4. Normalisation of aGvHD proteome pattern in response to treatment