Status:
TERMINATED
Everolimus in Combination With Cyclosporine A and Prednisolone for the Treatment of Graft Versus Host Disease
Lead Sponsor:
University Hospital Tuebingen
Conditions:
Graft Versus Host Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The present protocol is a dose-finding and toxicity study in preparation of a randomised study comparing current standard treatment CSA/prednisolone with the new combination CSA/prednisolone/everolimu...
Detailed Description
The primary objective of the present study is to evaluate the feasibility of treatment with everolimus in combination with CSA/prednisolone in patients with aGVHD after allogeneic HSCT. This evaluatio...
Eligibility Criteria
Inclusion
- Written informed consent prior to inclusion into the study
- Allogeneic HSCT from HLA-identical related or unrelated donors
- Clinically confirmed acute GVHD ≥ grade II
- Age \< 70 / \> 18 years, male or female
- Karnofsky performance status \> 60 %
Exclusion
- Oral treatment is not feasible
- Severe hepatic impairment Child-Pugh C
- Active cerebral epilepsy
- Renal failure (Creatinine clearance \< 50 ml/min)
- Life expectancy \< 3 months
- Known hypersensitivity to everolimus, sirolimus or to any of the excipients
- Confirmed pregnancy (serum β-HCG)
- Non-effective contraception for both, male and female patients, if the risk of conception exists
- Patients with limited legal capacity
- Patients unwilling and unable to undergo study procedures
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00373815
Start Date
September 1 2006
End Date
October 1 2009
Last Update
May 29 2014
Active Locations (1)
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1
Medical Center, Hematology & Oncology, University of Tuebingen
Tübingen, Germany, D-72076