Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00228839
Status:
COMPLETED
Last Update Posted:
2009-06-30
First Post:
2005-09-27
Brief Title:
GVH 022P Study Using Anti Tumor Necrosis Factor Antibody Infliximab for Treatment of Acute Graft Versus Host Disease
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
A Pediatric Phase I Pharmacokinetic Study Using Anti Tumor Necrosis Factor Antibody Infliximab for Treatment of Acute Graft Versus Host Disease
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Acute graft versus host disease GVHD remains one of the most significant and potentially lethal complications of allogeneic bone marrow transplantation Depending upon the type of transplant the incidence of acute GVHD varies between 20 - 50 in related donor transplants or as high as 70 - 90 in unrelated donor transplants Acute GVHD affects the skin liver and gastrointestinal GI tract and usually occurs within 20 - 40 days of the bone marrow infusion
Steroids are the standard initial treatment of acute GVHD with approximately 50 of the patients either free of disease or requiring no further therapy In the remaining patients the GVHD either does not respond or it comes back during the tapering of steroids These patients have a much worse prognosis with a mortality rate greater than 70 Studies using additional agents such as antithymocyte globulin ATG monoclonal antibodies and anti-lymphocyte globulin showed no improvement over the use of steroids alone This leads the investigators to look for new immunosuppressive agents that can reduce the risk and severity of acute GVHD
The major purpose of this study is to evaluate the way the body uses and absorbs the pharmacokinetic profile a drug called anti tumor necrosis factor antibody infliximab for the treatment of acute GVHD Infliximab is currently indicated for the treatment of immunologic-based diseases rheumatoid arthritis moderately to severely active Crohns disease and fistulizing Crohns disease assuming patients have had inadequate responses to conventional therapy It is not approved for the treatment of GVHD
This is a Phase I pharmacokinetic study that is coordinated by the Pediatric Blood and Marrow Transplant Consortium PBMTC The study will be conducted in the Blood and Marrow Transplantation BMT program at Childrens Healthcare of Atlanta - Egleston Emory University Department of Pediatrics The goal is to enroll 1 - 2 patients on this study accrual will be via the BMT program Eligible patients must be less than 18 years of age
Patients with newly diagnosed acute GVHD will be able to participate in the study Patients will receive a single dose of infliximab in the clinic Since this is a Phase I study the patients will have blood samples drawn to measure the pharmacokinetics of the drug A total of 16 blood samples will be drawn over 84 days The samples will be labeled with a code processed frozen and then sent in a batch to the PBMTC designated laboratory for testing Patients will continue on any drugs they were getting for the prevention of GVHD Additional doses of infliximab may be given This decision will be based on the results of the blood testing
Steroids are the standard initial treatment of acute GVHD with approximately 50 of the patients either free of disease or requiring no further therapy In the remaining patients the GVHD either does not respond or it comes back during the tapering of steroids These patients have a much worse prognosis with a mortality rate greater than 70 Studies using additional agents such as antithymocyte globulin ATG monoclonal antibodies and anti-lymphocyte globulin showed no improvement over the use of steroids alone This leads the investigators to look for new immunosuppressive agents that can reduce the risk and severity of acute GVHD
The major purpose of this study is to evaluate the way the body uses and absorbs the pharmacokinetic profile a drug called anti tumor necrosis factor antibody infliximab for the treatment of acute GVHD Infliximab is currently indicated for the treatment of immunologic-based diseases rheumatoid arthritis moderately to severely active Crohns disease and fistulizing Crohns disease assuming patients have had inadequate responses to conventional therapy It is not approved for the treatment of GVHD
This is a Phase I pharmacokinetic study that is coordinated by the Pediatric Blood and Marrow Transplant Consortium PBMTC The study will be conducted in the Blood and Marrow Transplantation BMT program at Childrens Healthcare of Atlanta - Egleston Emory University Department of Pediatrics The goal is to enroll 1 - 2 patients on this study accrual will be via the BMT program Eligible patients must be less than 18 years of age
Patients with newly diagnosed acute GVHD will be able to participate in the study Patients will receive a single dose of infliximab in the clinic Since this is a Phase I study the patients will have blood samples drawn to measure the pharmacokinetics of the drug A total of 16 blood samples will be drawn over 84 days The samples will be labeled with a code processed frozen and then sent in a batch to the PBMTC designated laboratory for testing Patients will continue on any drugs they were getting for the prevention of GVHD Additional doses of infliximab may be given This decision will be based on the results of the blood testing
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