Autologous Cytokine-induced Killer Cell Adoptive Immunotherapy for Acute Myeloid Leukemia and Myelodysplastic Syndrome
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 (n=20 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 (n=10).
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
blood count changes
three months
No
Yeh-Ching Linn, MBBS, MRCP
Principal Investigator
Singapore General Hospital
Singapore: Health Sciences Authority
CIK#1/2006
NCT00394381
October 2006
January 2012
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