Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00506948
Status:
TERMINATED
Last Update Posted:
2020-09-24
First Post:
2007-07-20
Brief Title:
Thymoglobulin Sirolimus and Mycophenolate Mofetil for Prevention of Acute Graft-Versus-Host Disease GVHD
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Thymoglobulin Sirolimus and Mycophenolate Mofetil for Prevention of Acute GVHD Following Allogeneic Hematopoietic Stem Cell Transplantation
Status:
TERMINATED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Halted due to high incidence of veno-oclusive disease of the liver
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is to learn if the combination of rabbit anti-thymocyte globulin Thymoglobulin sirolimus Rapamune and mycophenolate mofetil Cellcept can help to prevent graft versus host disease GVHD The safety of this drug combination will also be studied
Primary Objective To determine efficacy and toxicity of a regimen of thymoglobulin sirolimus and mycophenolate mofetil for prevention of acute GVHD after allogeneic stem cell transplantation from human leukocyte antigen HLA identical related or unrelated donors
Secondary Objective To assess engraftment chronic GVHD relapse and survival
Primary Objective To determine efficacy and toxicity of a regimen of thymoglobulin sirolimus and mycophenolate mofetil for prevention of acute GVHD after allogeneic stem cell transplantation from human leukocyte antigen HLA identical related or unrelated donors
Secondary Objective To assess engraftment chronic GVHD relapse and survival
Detailed Description:
Rabbit anti-thymocyte globulin rATG sirolimus and mycophenolate mofetil MMF are all designed to prevent GVHD
If you are found to be eligible to take part in this study you will receive rATG through a needle in your vein over 3-4 hours on each of the 4 days before the stem cell transplant
Beginning 2 days before the transplant you will take sirolimus by mouth once per day You will continue to receive sirolimus until 90 days after the transplant Beginning on Day 60 you will start taking increasingly lower doses of the study drug This is done so you can taper down slowly and be off of the drug on Day 90
Beginning on the day of the transplant you will take MMF by mouth 2 times a day You will continue to take MMF until 27 days after the transplant
Every week for the first 90-100 days after the transplant you will have study visits At this visit you will have a physical exam Blood about 1-2 tablespoons will be drawn for routine tests
You will remain on study for up to 90 days after transplantation You will be taken off study if intolerable side effects occur
Starting on Day 90 after the transplant you will continue to follow up with your transplant doctor at least every 3 months through 1 year after the transplant During these visits you will have physical exams Blood about 1-2 tablespoons will be drawn for routine tests Your doctor may request additional testing
This is an investigational study RATG sirolimus and MMF are all FDA approved for their use in the transplantation of solid organs like kidney and liver All 3 drugs are commercially available This particular combination and dose schedule is considered investigational Up to 30 patients will take part in this study All will be enrolled at MD Anderson
If you are found to be eligible to take part in this study you will receive rATG through a needle in your vein over 3-4 hours on each of the 4 days before the stem cell transplant
Beginning 2 days before the transplant you will take sirolimus by mouth once per day You will continue to receive sirolimus until 90 days after the transplant Beginning on Day 60 you will start taking increasingly lower doses of the study drug This is done so you can taper down slowly and be off of the drug on Day 90
Beginning on the day of the transplant you will take MMF by mouth 2 times a day You will continue to take MMF until 27 days after the transplant
Every week for the first 90-100 days after the transplant you will have study visits At this visit you will have a physical exam Blood about 1-2 tablespoons will be drawn for routine tests
You will remain on study for up to 90 days after transplantation You will be taken off study if intolerable side effects occur
Starting on Day 90 after the transplant you will continue to follow up with your transplant doctor at least every 3 months through 1 year after the transplant During these visits you will have physical exams Blood about 1-2 tablespoons will be drawn for routine tests Your doctor may request additional testing
This is an investigational study RATG sirolimus and MMF are all FDA approved for their use in the transplantation of solid organs like kidney and liver All 3 drugs are commercially available This particular combination and dose schedule is considered investigational Up to 30 patients will take part in this study All will be enrolled at MD Anderson
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