Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00460629
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2007-04-12
Brief Title:
Prophylactic Transfer of Leukemia-reactive T Cells After Allogeneic Transplantation
Sponsor:
University Hospital Carl Gustav Carus
Organization:
University Hospital Carl Gustav Carus
Study Overview
Official Title:
Specific Cellular Immunotherapy in Patients With Chronic Myeloid Leukemia After Allogeneic Stem Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2013-06
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:
Efforts to decrease the risk of GvHD by depleting T cells from the graft in CML patients have been complicated by an increased incidence of leukemia-relapse Newer protocols using CD34 selected hematopoietic cells from matched-sibling donors and subsequent infusion of T cells in incremental doses to treat or avoid relapse of disease seem to be more promising In this study we try to further optimize this approach by the prophylactic infusion of cytotoxic T cells activated ex-vivo against leukemia-associatedspecific antigens using peptide-pulsed dendritic cells
Detailed Description:
The conditioning protocol contains
Total Body Irradiation 8-12 Gy 4-6 x 2 Gy a 2 xdie day -9 to-7 Thiotepa 10 mgkg 2 x 5 mgkg day -5 Fludarabine 200 mgm2 5 x 40 mgm2 day -6 to-2 ATG Fresenius 25 mgkg 5 x 5 mgkg day -6 to-2 Cyclosporine A 1 mgkg Day -10 to-3
on day 0 CD34 cells after immunomagnetic selection are infused 4 x 10e6kg CD34 cellskg are required
On days 28 56 and 112 after transplantation cytotoxic T cells generated in-vitro are infused in patients who do not have signs of acute GvHD
Regular follow-up compromises immune monitoring including Tetramer analyses of Peptide-reactive T cells
Total Body Irradiation 8-12 Gy 4-6 x 2 Gy a 2 xdie day -9 to-7 Thiotepa 10 mgkg 2 x 5 mgkg day -5 Fludarabine 200 mgm2 5 x 40 mgm2 day -6 to-2 ATG Fresenius 25 mgkg 5 x 5 mgkg day -6 to-2 Cyclosporine A 1 mgkg Day -10 to-3
on day 0 CD34 cells after immunomagnetic selection are infused 4 x 10e6kg CD34 cellskg are required
On days 28 56 and 112 after transplantation cytotoxic T cells generated in-vitro are infused in patients who do not have signs of acute GvHD
Regular follow-up compromises immune monitoring including Tetramer analyses of Peptide-reactive T cells
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