21
Participants
Start Date
November 1, 2011
Primary Completion Date
April 30, 2016
Study Completion Date
April 30, 2016
Everolimus
"Start therapy: 2x 0.75 mg/day (morning and evening) to receive a serum trough level of 3 - 5 ng/ml. First evaluation of Everolimus serum level 3-7 days after start of therapy, second 7 days later, subsequently on study weeks 4, 6, 9, 12 and 16. Dose has to be adapted if trough level exceeds 5 ng/ml. As soon as Everolimus trough level exceeds 3 ng/ml after start of therapy, calineurine inhibitors (e.g. cyclosporine) will be reduced: halve of the dose for the 3 consecutive days, withdrawal on day 4.~Prednisone will be reduced accordingly (a 22 weeks scheme is recommended) Everolimus will be used for 98 days or 14 weeks, as described above Everolimus therapy might be extended (independently of the study) if the patient suffering from milde chronic GvHD (according to NIH criteria) or milde PTOLD and lung function score is not reduced more than 25% since begin of Everolimus therapy Everolimus will be reduced to 50% of the dosage for 2 weeks before withdraw (normally weeks 15 and 16"
Zentrum für Knochenmark- und Blutstammzelltransplantation,, Wiesbaden
Collaborators (1)
Deutsche Klinik fuer Diagnostik
OTHER
ClinAssess GmbH
INDUSTRY
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
OTHER