Acute Myeloid Leukemia
Conditions
Keywords
AML, high-risk AML, acute myeloid leukemia, NK cells, haploidentical natural killer cells, immunotherapy
Brief 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
Detailed description
Randomised controlled phase-2 trial to determine the efficacy of adoptive immunotherapy with haploidentical natural killer cells in high-risk acute myeloid leukemia
Interventions
BIOLOGICALNK cells
DRUGCytarabine
1 cycle of consolidation chemotherapy with high-dose cytarabine
Sponsors
German Research Foundation
Technische Universität Dresden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-year overall survival | 2 years after study inclusion | measure time of survival of each patiente up to 2 years after study inclusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relapse-free survival | 2 years after study inclusion | — |
| Yield and purity of NK cells (CD3-CD56+) after CD3 depletion and CD56 enrichment | timepoint of application of NK cells | — |
| NK cell analysis | 2 years after study inclusion | — |
| Time to relapse | 2 years after study inclusion | evaluate time to relapse for 2 years after study inclusion for each patient; calculate cumulative incidence of relapse |
| Incidence and severity of GVHD | 6 months after start of treatment | — |
| Incidence of (S)AEs | 5 weeks after start of treatment | — |
| Clinical performance (ECOG score) | 2 years after study inclusion | — |
Countries
Germany
Outcome results
None listed