Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00373815
Status:
TERMINATED
Last Update Posted:
2014-05-29
First Post:
2006-09-06
Brief Title:
Everolimus in Combination With Cyclosporine A and Prednisolone for the Treatment of Graft Versus Host Disease
Sponsor:
University Hospital Tuebingen
Organization:
University Hospital Tuebingen
Study Overview
Official Title:
A Phase I Dose Escalation Study With Everolimus in Combination With Cyclosporine A and Prednisolone for the Treatment of Acute GVHD After Allogeneic Hematopoietic Stem Cell Transplantation
Status:
TERMINATED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
high incidence of TTP poor recrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The present protocol is a dose-finding and toxicity study in preparation of a randomised study comparing current standard treatment CSAprednisolone with the new combination CSAprednisoloneeverolimus
Detailed Description:
The primary objective of the present study is to evaluate the feasibility of treatment with everolimus in combination with CSAprednisolone in patients with aGVHD after allogeneic HSCT This evaluation takes into account the following parameters
Feasibility of oral application everolimus
Daily dose needed to reach the targeted plasma level everolimus
Time to reach the targeted plasma level of everolimusSecondary objectivesThe study will evaluate the toxicity and safety of the treatment with ever-olimusCSAprednisolone with regard to
Incidence and severity of treatment induced toxic events
Incidence severity and seriousness of adverse events
Treatment induced morbidity
Treatment induced 1-year-mortality Furthermore the study will collect data about
Efficacy of everolimusCSAprednisolone on aGVHD
Drug interactions between everolimus and CSA
Feasibility of oral application everolimus
Daily dose needed to reach the targeted plasma level everolimus
Time to reach the targeted plasma level of everolimusSecondary objectivesThe study will evaluate the toxicity and safety of the treatment with ever-olimusCSAprednisolone with regard to
Incidence and severity of treatment induced toxic events
Incidence severity and seriousness of adverse events
Treatment induced morbidity
Treatment induced 1-year-mortality Furthermore the study will collect data about
Efficacy of everolimusCSAprednisolone on aGVHD
Drug interactions between everolimus and CSA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None