Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056979
Status:
TERMINATED
Last Update Posted:
2015-09-23
First Post:
2003-03-26
Brief Title:
Monoclonal Antibody Conditioning for Allogeneic Stem Cell Transplantation of Patients With Inherited Metabolic Storage Diseases
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Anti-CD45 YTH-24 YTH 54 and ANTI-CD52 CAMPATH-1H Monoclonal Antibody Conditioning Regimen for Allogeneic Stem Cell Transplantation of Patients With Inherited Metabolic Storage Diseases
Status:
TERMINATED
Status Verified Date:
2015-09
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 treats patients with an inherited disease that prevents the body from making a specific protein or enzyme needed for the bodys metabolism Lack of this enzyme causes accumulation of harmful or toxic substances in the body which leads to deterioration and failure of organs such as the brain or the heart This disease can be fatal
Some patients with inherited metabolic storage disease may benefit from an allogeneic stem cell transplant allogeneic means that the stem cells come from another person Stem cells are created in the bone marrow They mature into different types of blood cells that are needed including red blood cells white blood cells and platelets Stem cells when transplanted can make a new blood system Donor stem cells can make the protein or enzyme patients with this disease cells cannot The donor cells may prevent further accumulation of toxic substances It is hoped that the donor cells can prevent or stop the disease from progressing
This research study uses a new pre-treatment combination of two drugs Anti-CD45 and CAMPATH-1H Anti-CD45 and CAMPATH-1H are antibodies against certain types of blood cells CAMPATH-1H is particularly important because it stays active in the body for a long time after infusion which means it may work longer at preventing GVHD symptoms In addition to antibodies patients will receive Fludarabine which is a chemotherapy drug Fludarabine kills bone marrow cells and is given to reduce the bone marrow cells so that donor stem cells may take
Some patients with inherited metabolic storage disease may benefit from an allogeneic stem cell transplant allogeneic means that the stem cells come from another person Stem cells are created in the bone marrow They mature into different types of blood cells that are needed including red blood cells white blood cells and platelets Stem cells when transplanted can make a new blood system Donor stem cells can make the protein or enzyme patients with this disease cells cannot The donor cells may prevent further accumulation of toxic substances It is hoped that the donor cells can prevent or stop the disease from progressing
This research study uses a new pre-treatment combination of two drugs Anti-CD45 and CAMPATH-1H Anti-CD45 and CAMPATH-1H are antibodies against certain types of blood cells CAMPATH-1H is particularly important because it stays active in the body for a long time after infusion which means it may work longer at preventing GVHD symptoms In addition to antibodies patients will receive Fludarabine which is a chemotherapy drug Fludarabine kills bone marrow cells and is given to reduce the bone marrow cells so that donor stem cells may take
Detailed Description:
Fludarabine will be given as a daily IV intravenous by vein infusion for a total of 5 days CAMPATH-1H will be given as a daily 4-hour IV intravenous by vein infusion for three days Anti-CD45 will be given as a daily 6-hour IV infusion over the next 4 days Then patients will have a one-day rest period before receiving the stem cell transplant To help prevent the body from rejecting the transplant patients will also receive the drug FK506 starting two days before the transplant and continuing for three months If there is no GVHD the amount of FK506 patients are taking will be reduced by 20 every 2 weeks until this medication is stopped
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MAID | None | None | None |