Acute Myeloid Leukemia, Myelodysplastic Syndrome, High Grade
Conditions
Keywords
acute myeloid leukemia, myelodysplastic syndrome, autologous CIK cells, autologous peripheral blood stem cell transplant
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) 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 (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).
Interventions
PROCEDUREInfusion 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
Sponsors
National Medical Research Council (NMRC), Singapore
Singapore General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. For Group 1: AML or MDS post autologous peripheral blood or marrow stem cell transplant. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood count changes | three months |
| T lymphocyte subsets | three months |
| T cell functions | 3 months |
| adverse reactions | 24 hour |
Secondary
| Measure | Time frame |
|---|---|
| relapse rate | 5 year |
| survival | 5 year |
Countries
Singapore
Outcome results
None listed