Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00201799
Status:
COMPLETED
Last Update Posted:
2015-06-10
First Post:
2005-09-12
Brief Title:
Infliximab for the Prevention of Graft-versus-Host Disease Following Allogenic Hematopoietic Stem Cell Transplantation
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Trial of Infliximab for the Prevention of Acute Graft-versus-Host Disease Following Allogenic Hematopoietic Stem Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2015-06
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:
This study will evaluate the efficacy of infliximab in reducing the incidence of grade II-IV acute graft versus host disease by day 100 post-transplant in patients undergoing allogeneic hematopoietic stem cell transplant
Detailed Description:
Rationale Acute graft host disease GvHD remains a barrier to successful hematopoietic stem cell transplantation HCT used for the treatment of cancers in some patients GvHD can result from a lack of compatibility between the donor and recipient Research suggests another primary cause of GvHD comes from cytokines or a substance produced by cells of the immune system that affect the immune response in both positive and negative ways Infliximab is an antibody that directly targets the cytokine associated with GvHD This study is building upon previous research to assess infliximabs ability to prevent GvHD after HCT
Purpose This study is evaluating the efficacy of infliximab in reducing the incidence of GvHD after HCT The safety of this approach along with changes to specific cytokines from this treatment will also be measured
Treatment Patients in this study will receive infliximab through intravenous infusion Infliximab will be administered in six doses including one day before chemotherapy or radiotherapy after the stem cell infusion and then on days 7 14 28 and 42 Standard post-transplant treatments of cyclosporine Neoral and methotrexate Methotrexate will also be given through intravenous infusion Cyclosporine will be given on day 1 and the subsequent schedule will be determined on an individual basis Methotrexate will be administered on days 1 3 6 and 11 Several tests and exams will be given throughout the study to closely monitor patients
Purpose This study is evaluating the efficacy of infliximab in reducing the incidence of GvHD after HCT The safety of this approach along with changes to specific cytokines from this treatment will also be measured
Treatment Patients in this study will receive infliximab through intravenous infusion Infliximab will be administered in six doses including one day before chemotherapy or radiotherapy after the stem cell infusion and then on days 7 14 28 and 42 Standard post-transplant treatments of cyclosporine Neoral and methotrexate Methotrexate will also be given through intravenous infusion Cyclosporine will be given on day 1 and the subsequent schedule will be determined on an individual basis Methotrexate will be administered on days 1 3 6 and 11 Several tests and exams will be given throughout the study to closely monitor patients
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