Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00187096
Status:
COMPLETED
Last Update Posted:
2014-06-19
First Post:
2005-09-12
Brief Title:
Natural Killer NK Cell Transplantation for AML
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
Pilot Study Of Haplo-Identical Natural Killer Cell Transplantation For Acute Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2013-10
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 assess the safety and efficacy of infusing natural killer cells from a donor as treatment for patients with acute myeloid leukemia in remission or who have experienced relapse
Detailed Description:
Natural killer NK cells extracted from a parental donor are infused intravenously Most patients are given a multi-agent chemotherapeutic conditioning regimen prior to the infusion The conditioning regimen may be omitted for patients who have previously received traditional stem cell transplant
Details of Treatment Plan
Stratum 1 AML in complete remission
Cyclophosphamide 60 mgkg IV Day -7 Fludarabine 25 mgm2day IV Days -6 through -2 Donor pheresis Day -1 Start IL-2 on Day -1 then 3 times per week x 2 weeks NK Cell purification and infusion on Day 0
Stratum 2 AML that is refractory or relapsed or AML with increasing minimal residual disease
Clofarabine 40 mgm2 IV days -6 through -2 Etoposide 100 mgm2 IV days -6 through -2 Cyclophosphamide 400 mgm2 IV days -6 through 02 Donor pheresis Day -1 Start IL-2 Day -1 and then 3 times per week x 2 weeks NK Cell purification and infusion on Day 0
For patients who have received prior SCT the conditioning regimen may be omitted if the NK cells are obtained from the original SCT donor
Cytokine regimen stratum 1 and 2 1 million unitsm2 of IL-2 given subcutaneously three times per week for two weeks 6 doses starting on the evening of day -1
NK Cell Transplantation stratum 1 and 2 NK cells from haplo-identical family donor will be infused on day 0
Details of Treatment Plan
Stratum 1 AML in complete remission
Cyclophosphamide 60 mgkg IV Day -7 Fludarabine 25 mgm2day IV Days -6 through -2 Donor pheresis Day -1 Start IL-2 on Day -1 then 3 times per week x 2 weeks NK Cell purification and infusion on Day 0
Stratum 2 AML that is refractory or relapsed or AML with increasing minimal residual disease
Clofarabine 40 mgm2 IV days -6 through -2 Etoposide 100 mgm2 IV days -6 through -2 Cyclophosphamide 400 mgm2 IV days -6 through 02 Donor pheresis Day -1 Start IL-2 Day -1 and then 3 times per week x 2 weeks NK Cell purification and infusion on Day 0
For patients who have received prior SCT the conditioning regimen may be omitted if the NK cells are obtained from the original SCT donor
Cytokine regimen stratum 1 and 2 1 million unitsm2 of IL-2 given subcutaneously three times per week for two weeks 6 doses starting on the evening of day -1
NK Cell Transplantation stratum 1 and 2 NK cells from haplo-identical family donor will be infused on day 0
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