PhaseII,Open-label,Pilot Study Evaluating the Safety+Efficacy of Certican ® in the Prevention of Chronic Graft-versus-host Disease+Late Pulmonary Complications After Allogeneic Hematopoietic Cell Transplantation Blood

PHASE2CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

November 1, 2011

Primary Completion Date

April 30, 2016

Study Completion Date

April 30, 2016

Conditions
Condition After Allogenic Peripheral Stem Cell Transplantation (SCT)
Interventions
DRUG

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"

Trial Locations (1)

65191

Zentrum für Knochenmark- und Blutstammzelltransplantation,, Wiesbaden

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Deutsche Klinik fuer Diagnostik

OTHER

collaborator

ClinAssess GmbH

INDUSTRY

lead

Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

OTHER

NCT01509560 - PhaseII,Open-label,Pilot Study Evaluating the Safety+Efficacy of Certican ® in the Prevention of Chronic Graft-versus-host Disease+Late Pulmonary Complications After Allogeneic Hematopoietic Cell Transplantation Blood | Biotech Hunter | Biotech Hunter