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

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ClinicalTrials.gov Identifier: NCT02229266
Recruitment Status : Recruiting
First Posted : September 1, 2014
Last Update Posted : January 18, 2016
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Technische Universität Dresden

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

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Biological: NK cells Drug: Cytarabine Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2020


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 Name: chemotherapy




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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. Relapse-free survival [ Time Frame: 2 years after study inclusion ]
  3. Yield and purity of NK cells (CD3-CD56+) after CD3 depletion and CD56 enrichment [ Time Frame: timepoint of application of NK cells ]
  4. NK cell analysis [ Time Frame: 2 years after study inclusion ]
  5. Clinical performance (ECOG score) [ Time Frame: 2 years after study inclusion ]
  6. Incidence and severity of GVHD [ Time Frame: 6 months after start of treatment ]
  7. Incidence of (S)AEs [ Time Frame: 5 weeks after start of treatment ]


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Ages Eligible for Study:   60 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229266


Contacts
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Contact: Malte von Bonin, Dr. med. malte.bonin@uniklinikum-dresden.de
Contact: Kerstin Wirth kerstin.wirth@uniklinikum-dresden.de

Locations
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Germany
Klinikum Bayreuth Not yet recruiting
Bayreuth, Germany
Contact: Alexander Kiani, Prof. Dr. med.       alexander.kiani@klinikum-bayreuth.de   
Principal Investigator: Alexander Kiani, Prof. Dr. med.         
Klinikum Chemnitz Not yet recruiting
Chemitz, Germany
Contact: Regina Herbst, Dr. med.       r.herbst@skc.de   
Principal Investigator: Mathias Hänel, PD Dr. med.         
Universitätsklinikum Dresden Recruiting
Dresden, Germany
Contact: Malte von Bonin, Dr. med.       Malte.Bonin@uniklinikum-dresden.de   
Principal Investigator: Malte von Bonin, Dr. med.         
Sponsors and Collaborators
Technische Universität Dresden
German Research Foundation
Investigators
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Principal Investigator: Martin Bornhäuser, Prof. Dr. med. Universitätsklinikum Dresden

Additional Information:
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Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT02229266     History of Changes
Other Study ID Numbers: TUD-HINKL1-059
First Posted: September 1, 2014    Key Record Dates
Last Update Posted: January 18, 2016
Last Verified: January 2016
Keywords provided by Technische Universität Dresden:
AML
high-risk AML
acute myeloid leukemia
NK cells
haploidentical natural killer cells
immunotherapy
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents