Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089453
Status:
COMPLETED
Last Update Posted:
2012-04-19
First Post:
2004-08-05
Brief Title:
Study of KIR-Ligand Mismatched Haplo-Identical Natural Killer Cells Transfused Before Autologous Stem Cell Transplant
Sponsor:
University of Arkansas
Organization:
University of Arkansas
Study Overview
Official Title:
UARK 2003-18 A Phase II Study of KIR-Ligand Mismatched Haplo-Identical Natural Killer Cells Transfused Before Autologous Stem Cell Transplant in Relapsed Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2012-04
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:
The purpose of this study is to induce anti-myeloma responses in patients with high risk or relapsed myeloma using combination chemo- and immunotherapy comprising sequentially 1 lymphoid and myeloid suppressive conditioning 2 adoptive transfer of purified KIR-ligand mismatched Natural Killer cells from a haplo-identical donor and 3 autografting two weeks after infusion of NK cells to ensure autologous reconstitution Other objectives include establishing the response rate disease free survival progression free survival and toxicity of regimen Secondary objectives are to monitor the persistence of haplo-identical purified KIR-ligand mismatched Natural Killer cells by molecular methods select haplo-identical purified KIR-ligand mismatched donors and predict prior to therapy which donor will induce a response monitor Natural Killer cell reconstitution prior to and after autografting and establish Natural Killer cell clones after autografting and determine origin and specificity
Detailed Description:
This study will induce anti-myeloma responses in patients with high risk or relapsed myeloma using combination chemo- and immunotherapy comprising sequentially 1 lymphoid suppressive conditioning to avoid rejection of the donor NK cells 2 adoptive transfer of purified KIR-ligand mismatched Natural Killer cells from a haplo-identical donor and 3 autografting two weeks after infusion of NK cells to ensure autologous reconstitution
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