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Autologous Cytokine-induced Killer Cell Adoptive Immunotherapy for Acute Myeloid Leukemia and Myelodysplastic Syndrome

Phase 1/Phase 2
12 Years
75 Years
Not Enrolling
Acute Myeloid Leukemia, Myelodysplastic Syndrome, High Grade

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Trial Information

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

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).

Inclusion Criteria:

1. For Group 1: AML or MDS post autologous peripheral blood or marrow stem cell

2. For Group 2: High grade MDS ( RAEB or RAEBIT ) or AML, whom the haematologist in
charge has assessed and deemed unfit for chemotherapy with curative intent.Patients
must have fairly stable white cell count requiring only low dose or no
myelosuppressive medication

3. Patients must understand the trial nature of this treatment and accept the possible
absence of benefit.

Exclusion Criteria:

1. uncontrolled infection

2. life expectancy less than 6 weeks.

3. Contraindication to undergo one session of leukapheresis for PBMNC harvesting

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

blood count changes

Outcome Time Frame:

three months

Safety Issue:


Principal Investigator

Yeh-Ching Linn, MBBS, MRCP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Singapore General Hospital


Singapore: Health Sciences Authority

Study ID:




Start Date:

October 2006

Completion Date:

January 2012

Related Keywords:

  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome, High Grade
  • acute myeloid leukemia
  • myelodysplastic syndrome
  • autologous CIK cells
  • autologous peripheral blood stem cell transplant
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia