The trial investigates the efficacy of adoptive immunotherapy with haploidentical natural killer cells compared to standard chemotherapy (after first complete remission) in patients with a high-risk acute myeloid leukemia being older than 65 years of age and not eligible for allogeneic transplantation
Randomised controlled phase-2 trial to determine the efficacy of adoptive immunotherapy with haploidentical natural killer cells in high-risk acute myeloid leukemia
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
1 cycle of consolidation chemotherapy with high-dose cytarabine
Klinikum Bayreuth
Bayreuth, Germany
Klinikum Chemnitz
Chemnitz, Germany
Universitätsklinikum Dresden
Dresden, Germany
2-year overall survival
measure time of survival of each patiente up to 2 years after study inclusion
Time frame: 2 years after study inclusion
Time to relapse
evaluate time to relapse for 2 years after study inclusion for each patient; calculate cumulative incidence of relapse
Time frame: 2 years after study inclusion
Relapse-free survival
Time frame: 2 years after study inclusion
Yield and purity of NK cells (CD3-CD56+) after CD3 depletion and CD56 enrichment
Time frame: timepoint of application of NK cells
NK cell analysis
Time frame: 2 years after study inclusion
Clinical performance (ECOG score)
Time frame: 2 years after study inclusion
Incidence and severity of GVHD
Time frame: 6 months after start of treatment
Incidence of (S)AEs
Time frame: 5 weeks after start of treatment
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