This is a multi-centre, open label, prospective, non-randomized phase I/II trial in 20 patients including a safety-run in phase I part comprising 6 patients. Trial subjects will receive repeated immunotherapies with autologous Dendritic Cells (DCs), presenting two leukemia-associated antigens.
20 patients with AML who are in remission (ELN criteria by Döhner et al 2017) receive WT1/PRAME autologous DC vaccine by intradermal injection once per week during the first 4 weeks and 1 per month thereafter for 23 consecutive months. Primary objective is to assess the safety and tolerability of the DC vaccine in the aforementioned population and the feasibility. Secondary objectives include evaluation of clinical response and exploratory immune monitoring assessments.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Oslo University Hospital, Rikshospitalet
Oslo, Norway
Percentage of patients in whom treatment with the scheduled number of immunotherapies is feasible
Time frame: 2 years
Percentage of grade I/II, grade III/IV and grade ≥III toxicities in patients having received at least 1 immunotherapy
Time frame: 2 years
Overall survival
Time frame: 2 years
Relapse/Progression free survival
Time frame: 2 years
Time to progression (TTP).
Time frame: 2 years
Control of minimal residual disease (MRD)
Time frame: 2 years
ECOG performance status
Time frame: 2 years
Cellular immune responses to applied antigens
Time frame: 2 years
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