Randomised Controlled Phase-2 Trial to Determine the Efficacy of Adoptive Immunotherapy With NK Cells in High-risk AML

Randomised Controlled Phase-2 Trial to Determine the Efficacy of Adoptive Immunotherapy With Haploidentical Natural Killer Cells in High-risk Acute Myeloid Leukemia

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

Inclusion Criteria:

• Newly diagnosed AML other than acute promyelocytic leukemia (APL) according to WHO criteria
• In AML defined by cytogenetic aberrations the proportion of blasts may be <20%
• Age ≥60 years
• Clinical performance corresponding to ECOG score 0-2
• High-risk karyotype
• <5% myeloblasts in bone marrow ≥21 days after beginning of most recent chemotherapy
• maximal two preceding chemotherapy cycles
• Potentially available haploidentical family donor (child/ sibling), willing and fit for NK cell donation

Exclusion Criteria:

• AML with favorable or intermediate risk cytogenetic features
• Persistent aplasia following preceding chemotherapy
• Relapsed or refractory AML
• Known pre-existing autoimmune diseases
• Any severe concomitant condition which makes it undesirable for the patient to participate in the study
• Any condition which could jeorpadize compliance of the protocol
• Participation in another clinical trial during or within 4 weeks before study entry