NCT02229266

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

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 1, 2014

Completed
1 year until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2017

Completed
Last Updated

August 16, 2021

Status Verified

August 1, 2021

Enrollment Period

1.6 years

First QC Date

August 28, 2014

Last Update Submit

August 10, 2021

Conditions

Acute Myeloid Leukemia

Keywords

AMLhigh-risk AMLacute myeloid leukemiaNK cellshaploidentical natural killer cellsimmunotherapy

Outcome Measures

Primary Outcomes (1)

  • 2-year overall survival

    measure time of survival of each patiente up to 2 years after study inclusion

    2 years after study inclusion

Secondary Outcomes (7)

  • Time to relapse

    2 years after study inclusion

  • 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

  • Clinical performance (ECOG score)

    2 years after study inclusion

  • +2 more secondary outcomes

Study Arms (2)

NK cells

EXPERIMENTAL

Infusion of haploidentical NK cells after immunosuppression with cyclophosphamide and fludarabine, followed by immunostimulatory treatment with interleukin-2

Biological: NK cells

Control Intervention

ACTIVE COMPARATOR

1 cycle of consolidation chemotherapy with high-dose cytarabine

Drug: Cytarabine

Interventions

NK cellsBIOLOGICAL
Also known as: CD3-negative/ CD56-positive NK cells from HLA-haploidentical family, donors
NK cells
CytarabineDRUG

1 cycle of consolidation chemotherapy with high-dose cytarabine

Also known as: chemotherapy
Control Intervention

Eligibility Criteria

Age60 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Klinikum Bayreuth

Bayreuth, Germany

Location

Klinikum Chemnitz

Chemnitz, Germany

Location

Universitätsklinikum Dresden

Dresden, Germany

Location

Related Links

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

CytarabineDrug Therapy

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

CytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesTherapeutics

Study Officials

  • Martin Bornhäuser, Prof. Dr. med.

    Universitätsklinikum Dresden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2014

First Posted

September 1, 2014

Study Start

September 1, 2015

Primary Completion

April 22, 2017

Study Completion

April 22, 2017

Last Updated

August 16, 2021

Record last verified: 2021-08

Locations

DE(3)