Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113646
Status:
TERMINATED
Last Update Posted:
2018-03-16
First Post:
2005-06-09
Brief Title:
Non-Myeloablative HLA-Mismatched Ex-Vivo T-cell Depleted Stem Cell Transplantation for Hematologic Malignancies
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Non-Myeloablative HLA-Mismatched Ex-Vivo T-cell Depleted Stem Cell Transplantation for Hematologic Malignancies
Status:
TERMINATED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Expiration of MEDI-507
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if recipients of non-myeloablative ex-vivo T-cell depleted peripheral blood PBSC stem cell transplantation using a mismatched related donor will have less severe graft versus host disease GVHD transplant related mortality and less graft failure compared to alternative haploidentical stem cell transplantation
Detailed Description:
One major obstacle to further advancement in the role of bone marrow transplant BMT in hematological malignancies is graft-versus-host-disease GVHD which can best be prevented by removing T-cells from the donor stem cell product However previous experience with T-cell depletion has been associated with an increased rate of engraftment failure and leukemic relapse Another obstacle is that a large fraction of leukemia and lymphomas afflict older patients who are more prone to GVHD and have co-morbid conditions that prevent them from being a candidate for BMT
This trial uses a non-myeloablative conditioning regimen with cyclophosphamide MEDI-507 fludarabine and thymic irradiation followed by a T-cell depleted PBSC infusion Cyclosporine is used for GVHD prophylaxis and tapered beginning on day 35 Data from our mouse model and previous clinical trials have demonstrated that this approach can induce mixed chimerism without GVHD with the potential for conversion of mixed chimerism to full donor hematopoiesis following donor leukocyte infusions
This trial uses a non-myeloablative conditioning regimen with cyclophosphamide MEDI-507 fludarabine and thymic irradiation followed by a T-cell depleted PBSC infusion Cyclosporine is used for GVHD prophylaxis and tapered beginning on day 35 Data from our mouse model and previous clinical trials have demonstrated that this approach can induce mixed chimerism without GVHD with the potential for conversion of mixed chimerism to full donor hematopoiesis following donor leukocyte infusions
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