Randomised Controlled Phase-2 Trial to Determine the Efficacy of Adoptive Immunotherapy With NK Cells in High-risk AML
Acute Myeloid Leukemia
Conditions: official terms
Leukemia, Myeloid - Leukemia, Myeloid, Acute
Conditions: Keywords
AML, high-risk AML, acute myeloid leukemia, NK cells, haploidentical natural killer cells, immunotherapy
Study Type
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: NK cells Type: Biological
Name: Cytarabine Type: Drug
Overall Status
Not yet recruiting
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 60 Years
Gender: Both
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
Klinikum Bayreuth
Bayreuth, Germany
Status: Not yet recruiting
Contact: Alexander Kiani, Prof. Dr. med. - alexander.kiani@klinikum-bayreuth.de
Klinikum Chemnitz
Chemitz, Germany
Status: Not yet recruiting
Contact: Regina Herbst, Dr. med. - r.herbst@skc.de
Universitätsklinikum Dresden
Dresden, Germany
Status: Not yet recruiting
Contact: Malte von Bonin, Dr. med. - Malte.Bonin@uniklinikum-dresden.de
Start Date
September 2014
Completion Date
September 2019
Technische Universität Dresden
Technische Universität Dresden
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page