Ignite Creation Date:
2024-05-05 @ 9:46 PM
Last Modification Date:
2024-10-26 @ 10:09 AM
Study NCT ID:
NCT00968864
Status:
TERMINATED
Last Update Posted:
2022-04-22
First Post:
2009-08-28
Brief Title:
T-cell Depleted Alternative Donor Transplantation
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
A Phase II Study Using the CliniMACS Device for CD34 Cell Selection and T Cell Depletion for Graft-versus-Host Disease Prophylaxis in Alternative Donor Stem Cell Transplant Recipients
Status:
TERMINATED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor PI leaving institution no plans to continue this research at this time
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose is to determine the ability of CD34 selection and T cell depletion using the CliniMACS device to prevent severe acute graft-versus-host disease GVHD in patients receiving a stem cell transplant from an alternative unrelated and mismatched related donor The secondary objectives include evaluation of engraftment immune recovery and post-transplant infections
Patients requiring stem cell transplants for either malignant cancerous or non-malignant disease will be included in the study The recipients will be grouped into one of two groups based on whether the donor is mismatched related Cohort A or unrelated Cohort B The patient will receive a conditioning regimen including chemotherapy drugs andor total body irradiation based on the disease for which the transplant is performed
Patients requiring stem cell transplants for either malignant cancerous or non-malignant disease will be included in the study The recipients will be grouped into one of two groups based on whether the donor is mismatched related Cohort A or unrelated Cohort B The patient will receive a conditioning regimen including chemotherapy drugs andor total body irradiation based on the disease for which the transplant is performed
Detailed Description:
A major issue in alternative donor mismatched related and unrelated donor transplantation is the development of graft-versus-host disease GVHD Several clinical trials have shown that the use of T-cell depleted peripheral blood stem cells PBSC reduces GVHD in alternative donor transplants The purpose of this study is to determine the ability of CD34 positive selection and T cell depletion using the CliniMACS Device as the only GVHD prophylaxis to prevent severe acute GVHD in recipients of an alternative donor PBSC transplant Mismatched related donors will match at least 3 of 6 Human leukocyte antigensHLAhaplocompatible and unrelated donors will match at least 6 out of 8 HLA antigens with the transplant recipient The conditioning therapy including chemotherapy anti-thymocyte globulin ATG - total body irradiation TBI will be based on the patients diagnosis The transplant recipient will be followed for 5 years after transplant for GVHD engraftment post-transplant infections disease relapse and overall survival In addition this study will serve as a platform for a companion study of therapy to accelerate immune recovery after transplant
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