AML: Acute Myeloid Leukemia/ cancer of blood and bone marrow
Conditions
Brief summary
Part A: Safety: Occurrence of DLTs from the first vaccination (t=0) until 84 days after the third CBDC vaccination. The 6 patients receiving dose that is considered safe will also be included in first stage of the 2-stage phase 2 design., Part B: Activity: One-year WT1+ AML relapse-free survival rate from the time of the first vaccination as compared to historic controls.
Detailed description
Part A + B: One-year cumulative incidence of cGvHD (according to NIH criteria91) from the first vaccination until one year of follow-up., Part A + B: One-year overall survival rate from the time of first vaccination., Part A + B: One-year WT1+AML relapse-free survival rate, from the time of first vaccination., 4. Part A+B: One-year cumulative increase of WT1-specific immunity defined by In vitro T cell reactivity towards MHC class I and II-restricted WT1 epitopes by multiplex-cytokine assay and FACS of CD8/CD137 and CD4/CD154 expression by PBMCs stimulation with WT1 peptivator. Quantitative and qualitative FACS analysis of WT1-specific-positive CD8+ T cells using HLA-A2 multimers against a wide range of possible WT1 peptides.
Interventions
DRUGWT1-loaded CBDC Vaccine
Sponsors
Prinses Maxima Centrum voor Kinderoncologie B.V.
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: Safety: Occurrence of DLTs from the first vaccination (t=0) until 84 days after the third CBDC vaccination. The 6 patients receiving dose that is considered safe will also be included in first stage of the 2-stage phase 2 design., Part B: Activity: One-year WT1+ AML relapse-free survival rate from the time of the first vaccination as compared to historic controls. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A + B: One-year cumulative incidence of cGvHD (according to NIH criteria91) from the first vaccination until one year of follow-up., Part A + B: One-year overall survival rate from the time of first vaccination., Part A + B: One-year WT1+AML relapse-free survival rate, from the time of first vaccination., 4. Part A+B: One-year cumulative increase of WT1-specific immunity defined by In vitro T cell reactivity towards MHC class I and II-restricted WT1 epitopes by multiplex-cytokine assay and FACS of CD8/CD137 and CD4/CD154 expression by PBMCs stimulation with WT1 peptivator. Quantitative and qualitative FACS analysis of WT1-specific-positive CD8+ T cells using HLA-A2 multimers against a wide range of possible WT1 peptides. | — |
Countries
Netherlands
Outcome results
None listed