Randomised Controlled Phase-2 Trial to Determine the Efficacy of Adoptive Immunotherapy With NK Cells in High-risk AML
Conditions
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
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: NK cells Type: Biological
Name: Cytarabine Type: Drug
Overall Status
Not yet recruiting
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
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
Locations
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
Sponsors
Technische Universität Dresden
Source
Technische Universität Dresden
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page