Autologous Cytokine-induced Killer Cell Adoptive Immunotherapy for Acute Myeloid Leukemia and Myelodysplastic Syndrome
A phase I/II study to explore the feasibility and efficacy of autologous CIK cells in patients with acute myeloid leukemia (AML)/ high grade myelodysplastic syndrome (MDS)
- Group 1: As adjuvant therapy in minimal residual disease state after autologous PBSCT.
- Group 2: As an adoptive immunotherapy in untreated disease state when conventional therapy with curative intent is not applicable
|Acute Myeloid Leukemia Myelodysplastic Syndrome, High Grade||Procedure: Infusion of autologous CIK cells||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Autologous Cytokine-induced Killer Cell Adoptive Immunotherapy for Acute Myeloid Leukemia and Myelodysplastic Syndrome|
- blood count changes [ Time Frame: three months ]
- T lymphocyte subsets [ Time Frame: three months ]
- T cell functions [ Time Frame: 3 months ]
- adverse reactions [ Time Frame: 24 hour ]
- relapse rate [ Time Frame: 5 year ]
- survival [ Time Frame: 5 year ]
|Study Start Date:||October 2006|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Experimental: CIK infusion
Infusion of autologous CIK cells in study group. There is only one arm to this study
Procedure: Infusion of autologous CIK cells
Autologous CIK cells will be infused at timed intervals after autologous transplant for AML for group 1 patients, and with or without some cytoreduction treatment for group 2 patients
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 :
- Group 1 patients in minimal residual disease state post autologous peripheral blood stem cell transplant ( PBSCT ), and
- 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
- 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
- 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00394381
|Singapore General Hospital|
|Singapore, Singapore, 169608|
|Principal Investigator:||Yeh-Ching Linn, MBBS, MRCP||Singapore General Hospital|