Ignite Creation Date:
2024-05-05 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 9:40 AM
Study NCT ID:
NCT00587054
Status:
COMPLETED
Last Update Posted:
2017-03-10
First Post:
2007-12-21
Brief Title:
Trial of Allogeneic Stem Cell Transplants From HLA Compatible Related and Unrelated Donors After a Myeloablative Preparative Regimen With Hyperfractionated TBI Thiotepa and Fludarabine For Adult Patients With Lymphohematopoietic Disorders
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Trial of Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants From HLA Compatible Related and Unrelated Donors After a Myeloablative Preparative Regimen With Hyperfractionated TBI Thiotepa and Fludarabine For Treatment of Adult Patients 18 Years With Lymphohematopoietic Disorders
Status:
COMPLETED
Status Verified Date:
2017-01
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 is a phase II single-center study to evaluate the efficacy of a novel cytoreductive regimen followed by CD34E- selected T cell depleted allogeneic stem cell or soybean agglutinated and E-rosetted BM transplant as treatment for patients with acute and chronic leukemias lymphoma and myelodysplstic syndromePNH The impact of the change in conditioning regimen and use of CD34-selected T cell depleted PBSCs on transplanted related morbidity and mortality and disease free survival will be assessed
Detailed Description:
The purpose of this study is 1 to try to kill any cancer or precancer cells that are in your body and to reduce the side effects of a transplant which we have seen in our previous studies 2 to see if this treatment with a new recipe of radiation and chemotherapy can suppress your immune system enough for the stem cells to take and grow 3 to see if the specially prepared stem cells can grow in you without a problem called graft-versus-host disease GvHD occurring
One of the major side effects of any stem cell transplant is a condition known as graft vs host disease or GVHD GVHD is an immune reaction caused by certain cells from the transplanted stem cells called T-lymphocytes or T-cells The T-cells from your donor may see your organs as foreign and attack them New ways to remove the T-cells from the stem cells before the transplant are being used to try and prevent GVHD In some studies the removal of T-cells from the stem cells has been successful for many patients in preventing both short-term acute and long-term chronic forms of GVHD However the removal of T-cells may increase the chance that the new bone marrow developing from the stem cells will be rejected or will not function well Rejection of the transplant means that some of your own cells have survived the chemo and radiation therapy and are attacking the new bone marrow cells This condition can be lifethreatening because of an increased risk of infections and bleeding and would require your getting more treatment and additional stem cells Studies like this one are designed to find better ways to avoid GVHD without increasing the risk of other problems such as graft rejection
One of the major side effects of any stem cell transplant is a condition known as graft vs host disease or GVHD GVHD is an immune reaction caused by certain cells from the transplanted stem cells called T-lymphocytes or T-cells The T-cells from your donor may see your organs as foreign and attack them New ways to remove the T-cells from the stem cells before the transplant are being used to try and prevent GVHD In some studies the removal of T-cells from the stem cells has been successful for many patients in preventing both short-term acute and long-term chronic forms of GVHD However the removal of T-cells may increase the chance that the new bone marrow developing from the stem cells will be rejected or will not function well Rejection of the transplant means that some of your own cells have survived the chemo and radiation therapy and are attacking the new bone marrow cells This condition can be lifethreatening because of an increased risk of infections and bleeding and would require your getting more treatment and additional stem cells Studies like this one are designed to find better ways to avoid GVHD without increasing the risk of other problems such as graft rejection
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 |
|---|---|---|---|
| CA33049 | None | None | None |
| CA23766 | None | None | None |