drugset / Trial / NCT00856505

Safety Study of Calcineurin Inhibitor Free GvHD Prophylaxis in Allogeneic Stem Cell Transplantation

NCT00856505

Phase 1/2 Unknown 38 enrolled University Hospital Freiburg
Non-randomizedSingle-groupOpen-labelTreatment

Summary

In stem cell transplantation as treatment for malignant diseases, calcineurin inhibitors like cyclosporine A are commonly used to prevent tissue destruction (GvHD) by activated donor immune cells. The hypothesis for this study is, that replacing calcineurin inhibitors by everolimus and mycophenolate as GvHD prophylaxis not only reduces toxicity of the treatment but also improves tolerance induction of the donor T cells toward the host, eventually increasing the safety of stem cell transplantation.

Timeline

Start
2008-03
Primary completion
2010-03
Completion
2011-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule 1.5 mg
Subject Mycophenolate Sodium Unknown 720 mg

Indications