Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00088543
Status:
COMPLETED
Last Update Posted:
2015-03-18
First Post:
2004-07-29
Brief Title:
Thymoglobulin to Prevent Acute Graft vs Host Disease GvHD in Patients With Acute Lymphocytic Leukemia ALL or Acute Myelogenous Leukemia AML Receiving a Stem Cell Transplant
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Pilot Trial of Two Dose Levels of Thymoglobulin as Part of a Myeloablative-Conditioning for a Human Leukocyte Antigen HLA Identical Matched Related Donor MRD Stem Cell Transplant SCT With Cyclosporine CSa as Post-transplant Graft vs Host Disease GvHD Prophylaxis
Status:
COMPLETED
Status Verified Date:
2015-03
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 involves the use of a drug called Thymoglobulin which is approved in the USA to treat kidney transplant rejection and in Canada to treat and to prevent kidney transplant rejection Thymoglobulin is not approved for the treatment or prophylaxis of graft versus host disease in bone marrow transplantation This study is to evaluate two 2 doses of Thymoglobulin and its safety and effectiveness when used with a myeloablative conditioning regimen prior to receiving a stem cell transplant also called bone marrow transplantation from a matched related donor
A myeloablative regimen is typically composed of chemotherapy and radiation and destroys the subjects existing bone marrow
Subjects meeting all inclusion and exclusion criteria and who have a relative with matching genetically similar stem cells who are also willing to donate them ie matched-related-donor are eligible to participate in this study Following myeloablative therapy the donors cells are then transplanted ie infused into the subjects blood stream
One of the most common complications of this type of transplant is graft-versus-host disease GvHD This is a condition where the transplanted donor cells attack the transplant recipients body Treatments such as cyclosporine are used to minimize the risk of GvHD following stem cell transplantation
To enter this study subjects must be having a matched-related donor stem cell transplant If a subject qualifies for entry into this study heshe will be assigned to receive Thymoglobulin at a dose of 45 mgkg or 85 mgkg The treatment assignment is random and is not chosen by the subject or their physician
Subjects are admitted to the hospital for the transplant procedure and are treated with Thymoglobulin over 3-5 days just prior to receiving the donor stem cells The subject will also receive standard GvHD prophylaxis with cyclosporine Methotrexate which is commonly used by transplant centers to minimize the risk of GvHD will not be used in this study
Subjects will be monitored during treatment with Thymoglobulin and during the transplant hospitalization Additional subject monitoring occurs at month 1 100 days and 6 months following the transplant
Approximately 60 study subjects from approximately 14 transplant centers in the United States and Canada will be enrolled
A myeloablative regimen is typically composed of chemotherapy and radiation and destroys the subjects existing bone marrow
Subjects meeting all inclusion and exclusion criteria and who have a relative with matching genetically similar stem cells who are also willing to donate them ie matched-related-donor are eligible to participate in this study Following myeloablative therapy the donors cells are then transplanted ie infused into the subjects blood stream
One of the most common complications of this type of transplant is graft-versus-host disease GvHD This is a condition where the transplanted donor cells attack the transplant recipients body Treatments such as cyclosporine are used to minimize the risk of GvHD following stem cell transplantation
To enter this study subjects must be having a matched-related donor stem cell transplant If a subject qualifies for entry into this study heshe will be assigned to receive Thymoglobulin at a dose of 45 mgkg or 85 mgkg The treatment assignment is random and is not chosen by the subject or their physician
Subjects are admitted to the hospital for the transplant procedure and are treated with Thymoglobulin over 3-5 days just prior to receiving the donor stem cells The subject will also receive standard GvHD prophylaxis with cyclosporine Methotrexate which is commonly used by transplant centers to minimize the risk of GvHD will not be used in this study
Subjects will be monitored during treatment with Thymoglobulin and during the transplant hospitalization Additional subject monitoring occurs at month 1 100 days and 6 months following the transplant
Approximately 60 study subjects from approximately 14 transplant centers in the United States and Canada will be enrolled
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