Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00361413
Status:
TERMINATED
Last Update Posted:
2015-04-21
First Post:
2006-07-31
Brief Title:
Alefacept for Prevention of Graft Versus Host Disease GVHD
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
An Investigator Initiated Double Blind Randomized Study of Alefacept Treatment Prevention of Graft Versus Host Disease in Myeloablative Stem Cell Transplantation
Status:
TERMINATED
Status Verified Date:
2010-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
company withdrawal of the drug
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Alefacept AMEVIVE is an immunosuppressive dimeric fusion protein It was shown to interfere with lymphocyte activation by specifically binding to the lymphocyte antigen CD2 and inhibiting LFA-3CD2 interaction Alefacept was evaluated in two randomized double-blind placebo-controlled studies in adults with chronic 1 year plaque psoriasis and a minimum body surface area involvement of 10 who were candidates for or had previously received systemic therapy or phototherapy The response to alefacept was significantly better in both studies In both studies onset of response to alefacept treatment defined as at least 50 reduction of baseline Psoriasis Area and Severity Index PASI began 60 days after the start of therapy
Graft versus host disease GVHD is the most ominous side effect of allogeneic stem cell transplantation SCT It causes severe inflammatory process which is usually located to the skin gut and liver Treatment of GVHD consists of various immuno-suppressive and immuno-modulating drugs including steroids cyclosporine tacrolimus methotrexate etc These drugs unfortunately can also cause severe immunologic failure that makes the patient prone to infection and malignancy and other medication-specific side effects In spite of this effect on the immune system not all of the patients achieve control of GVHD which usually rapidly leads to death Despite the use of innovative immunosuppressive modalities the prognosis of steroid resistant GVHD is usually poor
It was shown that CD2 depletion of allografts could prevent GVHD Alefacept was never systemically tried in GVHD but A phase II study of BTI-322 a rat monoclonal IgG2b directed against the CD2 antigen in steroid-refractory acute GVHD showed a total response rate of 55 We showed that alefacept might have a beneficial effect in controlling steroid resistant aGVHD and chronic GVHD It was also shown to dramatically change the nature of transfusion associated GVHD
Graft versus host disease GVHD is the most ominous side effect of allogeneic stem cell transplantation SCT It causes severe inflammatory process which is usually located to the skin gut and liver Treatment of GVHD consists of various immuno-suppressive and immuno-modulating drugs including steroids cyclosporine tacrolimus methotrexate etc These drugs unfortunately can also cause severe immunologic failure that makes the patient prone to infection and malignancy and other medication-specific side effects In spite of this effect on the immune system not all of the patients achieve control of GVHD which usually rapidly leads to death Despite the use of innovative immunosuppressive modalities the prognosis of steroid resistant GVHD is usually poor
It was shown that CD2 depletion of allografts could prevent GVHD Alefacept was never systemically tried in GVHD but A phase II study of BTI-322 a rat monoclonal IgG2b directed against the CD2 antigen in steroid-refractory acute GVHD showed a total response rate of 55 We showed that alefacept might have a beneficial effect in controlling steroid resistant aGVHD and chronic GVHD It was also shown to dramatically change the nature of transfusion associated GVHD
Detailed Description:
None
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