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    Summary
    EudraCT Number:2013-003421-28
    Sponsor's Protocol Code Number:TUD-HINKL1-059
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-01-03
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2013-003421-28
    A.3Full title of the trial
    Randomised controlled phase-2 trial to determine the efficacy of adoptive immunotherapy with haploidentical natural killer cells in high-risk acute myeloid leukemia
    Randomisiert-kontrollierte Phase-2 Studie zum Wirksamkeitsnachweis der Immuntherapie mit haploidenten natürlichen Killerzellen bei Hochrisiko-AML
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomised trial to determine the efficacy of immunotherapy with natural killer cells in high-risk acute myeloid leukemia
    Randomisierte Studie zum Wirksamkeitsnachweis der Immuntherapie mit natürlichen Killerzellen bei Akuter Myeloischer Leukämie unter Hochrisikokonstellation
    A.3.2Name or abbreviated title of the trial where available
    HINKL
    A.4.1Sponsor's protocol code numberTUD-HINKL1-059
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTechnische Universität Dreden
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDeutsche Forschungsgemeinschaft
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Dresden
    B.5.2Functional name of contact pointMedizinische Klinik I
    B.5.3 Address:
    B.5.3.1Street AddressFetscherstrasse 74
    B.5.3.2Town/ cityDresden
    B.5.3.3Post code01307
    B.5.3.4CountryGermany
    B.5.4Telephone number+493514583965
    B.5.5Fax number+493514584367
    B.5.6E-mailjana.hase@uniklinikum-dresden.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCD3-negative/ CD56-positive NK cells from HLA-haploidentical family donors
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeCell based medicinal product other than ATMP
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Newly diagnosed high-risk AML other than acute promyelocytic leukemia, ≥20% blasts
    neu diagnostizierte AML (außer Promyelozytenleukämie); ≥20% Blasten
    E.1.1.1Medical condition in easily understood language
    Newly diagnosed high-risk Acute Myeloid Leukemie
    neu diagnostizierte Akute Myeloische Leukämie
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10000886
    E.1.2Term Acute myeloid leukemia
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of haploidentical NK-cell based consolidation with standard cytarabine based consolidation in elderly patients suffering from AML with high risk of fatal relapse and no option for allogeneic stem cell transplantation (SCT).
    E.2.2Secondary objectives of the trial
    - To compare the time to relapse (TTR), the cumulative incidence of relapse (CIR) and relapse-free survival (RFS) between the two study groups
    - To investigate the yield and purity of NK cells (CD3-CD56+) after CD3 de-pletion and CD56 enrichment
    - To investigate patients NC cell recovery, NK cell chimerism, NK phenotype and functional capacity of NK cells at various time points after infusion
    - To compare tolerability and safety of the two interventions
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Newly diagnosed AML other than acute promyelocytic leukemia (APL) according to WHO criteria, i.e. bone marrow aspirate or biopsy must have contained ≥20% blasts
    • 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 (either two induction cycles or one induction + one consolidation cycle)
    • Study inclusion (experimental or control intervention) latest 56 days after preceding chemotherapy
    • Reconstitution of peripheral blood leukocytes following chemotherapy (total leukocytes >1.5 GPT/l; neutrophil granulocytes >0.5 GPT/l)
    • No available HLA-matched (≥ 9 of 10 HLA-alleles) stem cell donor or unfit for allogeneic hematopoietic stem cell transplantation
    • Available haploidentical family donor, willing and fit for NK cell donation
    E.4Principal exclusion criteria
    • AML with favorable risk cytogenetic features, i.e. t(15;17) or PML-RAR alpha transcript or t(8;21) or RUNX1 transcript or inv(16) or CBFa transcript
    • AML with t(9;11)(p22;q23)
    • AML with intermediate risk cytogenetic features, i.e. no high-risk cytogenetic features as defined in inclusion criteria and no favorable cyto-genetic features as defined in exclusion criteria, FLT3-ITD ratio ≤0.8
    • Persistent aplasia following preceding chemotherapy
    • Relapsed or refractory AML
    • Available HLA-matched (≥9 of 10 HLA-alleles) stem cell donor and patient fit for allogeneic stem cell transplantation
    • Age <60 years
    • Known pre-existing autoimmune diseases
    • Any severe concomitant condition which makes it undesirable for the patient to participate in the study (e.g. end stage irreversible multi organ failure, HIV infection, uncontrolled active infections >°2 )
    • Any condition which could jeorpadize compliance of the protocol
    • Participation in another clinical trial (investigational drug therapy outside of this trial) during or within 4 weeks before study entry
    E.5 End points
    E.5.1Primary end point(s)
    2-year overall survival
    2 Jahres Gesamtüberleben
    E.5.1.1Timepoint(s) of evaluation of this end point
    2-year after study inclusion
    2 Jahre nach Studieneinschluss
    E.5.2Secondary end point(s)
    • Time to relapse (TTR), cumulative incidence of relapse (CIR),
    • Relapse-free survival (RFS),
    • Yield and purity of NK cells (CD3-CD56+) after CD3 depletion and CD56 enrichment,
    • Patient NK cell recovery
    • NK cell chimerism
    • NK phenotype s
    • Clinical performance (ECOG score)
    • Incidence and severity of GVHD
    • Incidence of AEs and SAEs
    E.5.2.1Timepoint(s) of evaluation of this end point
    up to 2 years from study inclusion
    bis 2 Jahre nach Studieneinschluss
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 56
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 56
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state56
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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