Randomised Controlled Phase-2 Trial to Determine the Efficacy of Adoptive Immunotherapy With NK Cells in High-risk AML (HINKL)

August 10, 2021 updated by: Technische Universität Dresden

Randomised Controlled Phase-2 Trial to Determine the Efficacy of Adoptive Immunotherapy With Haploidentical Natural Killer Cells in High-risk Acute Myeloid Leukemia

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bayreuth, Germany
        • Klinikum Bayreuth
      • Chemnitz, Germany
        • Klinikum Chemnitz
      • Dresden, Germany
        • Universitätsklinikum Dresden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NK cells
Infusion of haploidentical NK cells after immunosuppression with cyclophosphamide and fludarabine, followed by immunostimulatory treatment with interleukin-2
Biological: NK cells
Other Names:
  • CD3-negative/ CD56-positive NK cells from HLA-haploidentical family
  • donors
Active Comparator: Control Intervention
1 cycle of consolidation chemotherapy with high-dose cytarabine
Drug: Cytarabine
1 cycle of consolidation chemotherapy with high-dose cytarabine
Other Names:
  • chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year overall survival
Time Frame: 2 years after study inclusion
measure time of survival of each patiente up to 2 years after study inclusion
2 years after study inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to relapse
Time Frame: 2 years after study inclusion
evaluate time to relapse for 2 years after study inclusion for each patient; calculate cumulative incidence of relapse
2 years after study inclusion
Relapse-free survival
Time Frame: 2 years after study inclusion
2 years after study inclusion
Yield and purity of NK cells (CD3-CD56+) after CD3 depletion and CD56 enrichment
Time Frame: timepoint of application of NK cells
timepoint of application of NK cells
NK cell analysis
Time Frame: 2 years after study inclusion
2 years after study inclusion
Clinical performance (ECOG score)
Time Frame: 2 years after study inclusion
2 years after study inclusion
Incidence and severity of GVHD
Time Frame: 6 months after start of treatment
6 months after start of treatment
Incidence of (S)AEs
Time Frame: 5 weeks after start of treatment
5 weeks after start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technische Universität Dresden

Collaborators

German Research Foundation

Investigators

  • Principal Investigator: Martin Bornhäuser, Prof. Dr. med., Universitätsklinikum Dresden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

April 22, 2017

Study Completion (Actual)

April 22, 2017

Study Registration Dates

First Submitted

August 28, 2014

First Submitted That Met QC Criteria

August 29, 2014

First Posted (Estimate)

September 1, 2014

Study Record Updates

Last Update Posted (Actual)

August 16, 2021

Last Update Submitted That Met QC Criteria

August 10, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUD-HINKL1-059

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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