Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113828
Status:
TERMINATED
Last Update Posted:
2018-03-15
First Post:
2005-06-10
Brief Title:
Non-Myeloablative HLA-Matched 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-Matched 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?:
Insufficient accrual
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 trial is to determine if patients with hematologic diseases who have a HLA 66 matched related donor and are not eligible for a standard myeloablative stem cell transplant will have less severe graft versus host disease GVHD transplant related mortality and less graft failure when treated with a non-myeloablative T-cell depleted stem cell transplant
Detailed Description:
Our prior experience in the lab and in clinical trials with non-myeloablative HLA-matched and mismatched transplant strategies have been remarkable for a low transplant related mortality rate but a still formidable risk of GVHD and graft rejection In this trial we have incorporated a combination ex-vivo T-cell depletion strategy to prevent GVHD with vigorous in vivo depletion of host and to a lesser extent donor T-cells to prevent graft rejection
Patients will receive non-myeloablative conditioning with cyclophosphamide thymoglobulin fludarabine and thymic irradiation followed by a T-cell depleted PBSC infusion Cyclosporine will be given 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
Patients will receive non-myeloablative conditioning with cyclophosphamide thymoglobulin fludarabine and thymic irradiation followed by a T-cell depleted PBSC infusion Cyclosporine will be given 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