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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Everolimus tablets, 1.5mg/day bid, dosage adjusted to plasma levels Mycophenolate sodium, 720mg/day bid Duration: Mycophenolate tapering starts at day 56 after stem cell transplantation Everolimus tapering starts at day 100 after stem cell transplantation if no GvHD evident
University Medical Center, Division Hematology/Oncology
Freiburg im Breisgau, Baden-Wurttemberg, Germany
RECRUITINGToxicity according to CTCAE v3.0
Time frame: after 100 days and one year after treatment start
Hematopoietic engraftment
Time frame: day 30 after stem cell transplantation
Incidence of acute and chronic GvHD
Time frame: one year after stem cell transplantation
Progression free survival
Time frame: Day 100 and one year after stem cell transplantation
Overall survival
Time frame: day 100 and one year after stem cell transplantation
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