Randomised Controlled Phase-2 Trial to Determine the Efficacy of Adoptive Immunotherapy With NK Cells in High-risk AML
NCT ID: NCT02229266
Last Updated: 2021-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
1 participants
INTERVENTIONAL
2015-09-30
2017-04-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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NK cells
Infusion of haploidentical NK cells after immunosuppression with cyclophosphamide and fludarabine, followed by immunostimulatory treatment with interleukin-2
NK cells
Control Intervention
1 cycle of consolidation chemotherapy with high-dose cytarabine
Cytarabine
1 cycle of consolidation chemotherapy with high-dose cytarabine
Interventions
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NK cells
Cytarabine
1 cycle of consolidation chemotherapy with high-dose cytarabine
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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
60 Years
99 Years
ALL
No
Sponsors
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German Research Foundation
OTHER
Technische Universität Dresden
OTHER
Responsible Party
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Principal Investigators
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Martin Bornhäuser, Prof. Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Dresden
Locations
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Klinikum Bayreuth
Bayreuth, , Germany
Klinikum Chemnitz
Chemnitz, , Germany
Universitätsklinikum Dresden
Dresden, , Germany
Countries
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Related Links
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Study Alliance Leukemia
Universitätsklinikum Dresden, Medizinische Klinik I
Other Identifiers
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TUD-HINKL1-059
Identifier Type: -
Identifier Source: org_study_id
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