Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00394381
Status:
COMPLETED
Last Update Posted:
2017-02-10
First Post:
2006-10-31
Brief Title:
Autologous Cytokine-induced Killer Cell Adoptive Immunotherapy for Acute Myeloid Leukemia and Myelodysplastic Syndrome
Sponsor:
Singapore General Hospital
Organization:
Singapore General Hospital
Study Overview
Official Title:
Autologous Cytokine-induced Killer Cell Adoptive Immunotherapy for Acute Myeloid Leukemia and Myelodysplastic Syndrome
Status:
COMPLETED
Status Verified Date:
2017-02
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:
A phase III study to explore the feasibility and efficacy of autologous CIK cells in patients with acute myeloid leukemia AML high grade myelodysplastic syndrome MDS
1 Group 1 As adjuvant therapy in minimal residual disease state after autologous PBSCT
2 Group 2 As an adoptive immunotherapy in untreated disease state when conventional therapy with curative intent is not applicable
1 Group 1 As adjuvant therapy in minimal residual disease state after autologous PBSCT
2 Group 2 As an adoptive immunotherapy in untreated disease state when conventional therapy with curative intent is not applicable
Detailed Description:
This is a Phase I II study on the feasibility efficacy of adoptive immunotherapy with autologous CIK cells for the following 2 groups of patients who have AML or high grade MDS
1 Group 1 patients in minimal residual disease state post autologous peripheral blood stem cell transplant PBSCT and
2 Group 2 patients with untreated high grade MDS or AML who are not fit for standard curative intent chemotherapy
The CIK cells will be generated by leukapheresis from patients and cultured in GMP facilities Four repeated infusions will be given for a target dose of 1x10e10 T cell per infusion
Efficacy will be assessed by
1 Disease free survival compared to historical control in group 1 given CIK cells post autologous PBSCT as adjuvant immunotherapy n20 over 3 years and
2 Effect on the peripheral or marrow leukemia cell load in group 2 patients given CIK cells as alternative therapy in place of chemotherapy n10
1 Group 1 patients in minimal residual disease state post autologous peripheral blood stem cell transplant PBSCT and
2 Group 2 patients with untreated high grade MDS or AML who are not fit for standard curative intent chemotherapy
The CIK cells will be generated by leukapheresis from patients and cultured in GMP facilities Four repeated infusions will be given for a target dose of 1x10e10 T cell per infusion
Efficacy will be assessed by
1 Disease free survival compared to historical control in group 1 given CIK cells post autologous PBSCT as adjuvant immunotherapy n20 over 3 years and
2 Effect on the peripheral or marrow leukemia cell load in group 2 patients given CIK cells as alternative therapy in place of chemotherapy n10
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