Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001748
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
HLA-Mismatched Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Hematological Malignancies
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
HLA-Mismatched Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Hematological Malignancies
Status:
COMPLETED
Status Verified Date:
1999-08
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:
Many patients with hematological malignancies potentially curable by bone marrow transplantation are not considered for transplantation because an HLA identical family or unrelated donor is unavailable For these patients the only curative option is a transplant from a partially matched family donor Such transplants are feasible but are less successful than matched sibling donor transplants The main problems with mismatched transplants are graft rejection graft-vs-host disease and regimen-related mortality This restricts the use of mismatched transplants to patients less than 45 years at high risk of dying from the hematological malignancy
This protocol evaluates a new preparative regimen designed to ensure stem cell engraftment by increased immunosuppression followed by a G-CSF mobilized T cell depleted stem cell rich peripheral blood progenitor cell PBPC transplant from a mismatched related donor in patients with high risk hematological malignancies
This phase I study evaluates engraftment and GVHD following T cell depleted HLA-mismatched PBPC transplants Stopping rules will be used to make modifications to the protocol in the event of graft failure
The end points of the study are graft take acute and chronic GVHD leukemic relapse transplant-related mortality death and leukemia-free survival Patients will be followed up for 5 years It is planned to treat up to 35 patients aged between 10 and 45 years
This protocol evaluates a new preparative regimen designed to ensure stem cell engraftment by increased immunosuppression followed by a G-CSF mobilized T cell depleted stem cell rich peripheral blood progenitor cell PBPC transplant from a mismatched related donor in patients with high risk hematological malignancies
This phase I study evaluates engraftment and GVHD following T cell depleted HLA-mismatched PBPC transplants Stopping rules will be used to make modifications to the protocol in the event of graft failure
The end points of the study are graft take acute and chronic GVHD leukemic relapse transplant-related mortality death and leukemia-free survival Patients will be followed up for 5 years It is planned to treat up to 35 patients aged between 10 and 45 years
Detailed Description:
Many patients with hematological malignancies potentially curable by bone marrow transplantation are not considered for transplantation because an HLA identical family or unrelated donor is unavailable For these patients the only curative option is a transplant from a partially matched family donor Such transplants are feasible but are less successful than matched sibling donor transplants The main problems with mismatched transplants are graft rejection graft-vs-host disease and regimen-related mortality This restricts the use of mismatched transplants to patients less than 45 years at high risk of dying from the hematological malignancy
This protocol evaluates a new preparative regimen designed to ensure stem cell engraftment by increased immunosuppression followed by a G-CSF mobilized T cell depleted stem cell rich peripheral blood progenitor cell PBPC transplant from a mismatched related donor in patients with high risk hematological malignancies
This phase I study evaluates engraftment and GVHD following T cell depleted HLA-mismatched PBPC transplants Stopping rules will be used to make modifications to the protocol in the event of graft failure
The end points of the study are graft take acute and chronic GVHD leukemic relapse transplant-related mortality death and leukemia-free survival Patients will be followed up for 5 years It is planned to treat up to 35 patients aged between 10 and 45 years
This protocol evaluates a new preparative regimen designed to ensure stem cell engraftment by increased immunosuppression followed by a G-CSF mobilized T cell depleted stem cell rich peripheral blood progenitor cell PBPC transplant from a mismatched related donor in patients with high risk hematological malignancies
This phase I study evaluates engraftment and GVHD following T cell depleted HLA-mismatched PBPC transplants Stopping rules will be used to make modifications to the protocol in the event of graft failure
The end points of the study are graft take acute and chronic GVHD leukemic relapse transplant-related mortality death and leukemia-free survival Patients will be followed up for 5 years It is planned to treat up to 35 patients aged between 10 and 45 years
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 |
|---|---|---|---|
| 98-H-0122 | None | None | None |