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 transplantation; Injury, Occupational Diseases, Poisoning; Failure and rejection of transplanted organs and tissues

• Registration Number: ISRCTN03911524
• Lead Sponsor: Hannover Medical School (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-19
• Last Update Posted: 13 January 2015

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