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

Study Overview
=================
Brief Summary
-----------------
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

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 : 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).

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

Conditions
-----------------
Acute Myeloid Leukemia, Myelodysplastic Syndrome, High Grade

Intervention / Treatment
-----------------
* Procedure: Infusion of autologous CIK cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For Group 1: AML or MDS post autologous peripheral blood or marrow stem cell transplant. 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 Patients must understand the trial nature of this treatment and accept the possible absence of benefit. Exclusion Criteria: uncontrolled infection life expectancy less than 6 weeks. Contraindication to undergo one session of leukapheresis for PBMNC harvesting

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CIK infusion<br>Infusion of autologous CIK cells in study group. There is only one arm to this study | Procedure: Infusion of autologous CIK cells<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood count changes |  | three months | 
| T lymphocyte subsets |  | three months | 
| T cell functions |  | 3 months | 
| adverse reactions |  | 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relapse rate |  | 5 year | 
| survival |  | 5 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute myeloid leukemia, myelodysplastic syndrome, autologous CIK cells, autologous peripheral blood stem cell transplant