Clinical trial NCT02229266: Randomised Controlled Phase-2 Trial to Determine the Efficacy of Adoptive Immunotherapy With NK Cells in High-risk AML
Official title: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Keywords: AML
high-risk AML
acute myeloid leukemia
NK cells
haploidentical natural killer cells
immunotherapy
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2014-09-01
Enrollment: 1
Sex: ALL
Minimum age (years): 60
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: 2-year overall survival
timeFrame: 2 years after study inclusion
Secondary outcomes:
measure: Time to relapse
timeFrame: 2 years after study inclusion
measure: Relapse-free survival
timeFrame: 2 years after study inclusion
measure: Yield and purity of NK cells (CD3-CD56+) after CD3 depletion and CD56 enrichment
timeFrame: timepoint of application of NK cells
measure: NK cell analysis
timeFrame: 2 years after study inclusion
measure: Clinical performance (ECOG score)
timeFrame: 2 years after study inclusion
measure: Incidence and severity of GVHD
timeFrame: 6 months after start of treatment
measure: Incidence of (S)AEs
timeFrame: 5 weeks after start of treatment
Other outcomes:
Locations:
city: Bayreuth
country: Germany
facility: Klinikum Bayreuth
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz
city: Dresden
country: Germany
facility: Universitätsklinikum Dresden
Study officials:
affiliation: Universitätsklinikum Dresden
name: Martin Bornhäuser, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: