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

• Status: Terminated
• Trial end date: 2017-04-22
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Technische Universität Dresden
• Collaborator: German Research Foundation
• Treatments: Cytarabine

Criteria

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