Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00117702
Status:
TERMINATED
Last Update Posted:
2009-06-18
First Post:
2005-06-30
Brief Title:
Prevention of the Graft-Versus-Host-Disease in Patients After Stem Cell Transplantation With Tacrolimus and Everolimus
Sponsor:
Technische Universität Dresden
Organization:
Technische Universität Dresden
Study Overview
Official Title:
Prophylaxis of the Graft-Versus-Host-Disease in Patients After Allogeneic Stem Cell Transplantation With a Combination of Tacrolimus and Everolimus
Status:
TERMINATED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
safety reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this pilot study is to provide preliminary data about the efficacy and the safety of the combination of tacrolimus with everolimus in the prophylaxis of the graft-versus-host-disease GvHD in patients after allogeneic stem cell transplantation
Detailed Description:
The allogeneic stem cell transplantation is a successful therapeutic approach in the treatment of a number of hematologic diseases Nevertheless it is associated with substantial risks and complications A major life-threatening complication that occurs in the post transplantation period is the graft versus host disease especially its severe forms Grade III and Grade IV For this reason a combined immunosuppressive therapy is standard in patients after a stem cell transplantation In this regard the combination between cyclosporin A and methotrexate in the prevention of GvHD has been particularly successful However the incidence rate of GvHD and consequent mortality are still fairly high Besides the therapy itself is accompanied by serious side effects Therefore there is a need for a more efficient less toxic combined immunosuppressive therapy The purpose of this pilot study is to test a new combination of immunosuppressives tacrolimus and everolimus for the prevention of GvHD after an allogeneic stem cell transplantation Tacrolimus is a macrolide immunosuppressant that acts as a calcineurin inhibitor thereby preventing the activation and proliferation of the T-lymphocytes Everolimus is a semisynthetic macrocyclic lactone that inhibits the activity of a key protein involved in the regulation of the cell cycle the so called m-TOR protein Both medicaments act complementary and potently inhibit the proliferation of immune cells Previous studies have shown that the combination of tacrolimus with everolimus decreases significantly the rejection rate after solid organ transplantation and this combination is generally well tolerated
This study is designed as a prospective single-center non-randomized open-label non-controlled pilot study Study related visits are scheduled to take place at regular time intervals and the patients will be followed up to one year after the stem cell transplantation The study is designed and will be conducted in accordance with the ICH-GCP guidelines and the respective national and international laws
This study is designed as a prospective single-center non-randomized open-label non-controlled pilot study Study related visits are scheduled to take place at regular time intervals and the patients will be followed up to one year after the stem cell transplantation The study is designed and will be conducted in accordance with the ICH-GCP guidelines and the respective national and international laws
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-000161-19 EudraCT Nr | None | None | None |