Randomised controlled phase-2 trial to determinate the efficacy of adoptive immunotherapy with haploidentical natural killer cells in high-risk acute myeloid leukemia (HINKL)

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Most patients diagnosed with acute myeloid leukemia (AML) are older than 60 years. One third of these patients have chromosomal changes which make the disease very aggressive and lead to a disastrous prognosis of only 4-6 months even when treated with intensive chemotherapy. Stem cell transplantation (SCT) from a matched donor can improve the prognosis considerably due to immune reactions of donor immune cells against the patient’s leukemia cells. However, not all patients have a matched donor, and many are not fit enough to stand the exhausting transplantation procedure. For these patients, the transfusion of special immune cells, so called NK cells, from their siblings or offspring is a promising treatment option. The NK cells are also able to induce immune reactions against leukemia cells, and the transfusion is not as exhausting as SCT. The anti-leukemia effect of NK cells has been shown in a number of trials before, however, most of these data originate from studies in children, and the results have not been compared with the standard chemotherapy treatment. In the HINKL trial proposed here, elderly patients with a high-risk AML who have no option for a SCT will receive a standard chemotherapy in order to reduce the leukemia burden and once this was successful, they will receive either the standard chemotherapy for treatment consolidation or the NK cell transplantation. The survival of both groups will be compared after two years. The goal of the trial is to show that treatment with NK cells conveys a better prognosis than standard chemotherapy.