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    Summary
    EudraCT Number:2013-005446-11
    Sponsor's Protocol Code Number:FFM-CIK-CellStudy01
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-09-25
    Trial 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 number2013-005446-11
    A.3Full title of the trial
    A prospective phase I/II study to investigate the feasibility, safety and efficacy of IL-15 activated cytokine induced killer (CIK) cells in relapsing patients with acute leukemia or myelodysplastic syndromes after allogeneic stem cell transplantation

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A prospective phase I/II study to investigate the feasibility, safety and efficacy of IL-15 activated cytokine induced killer (CIK) cells in relapsing patients with acute leukemia or myelodysplastic syndromes after allogeneic stem cell transplantation

    A.4.1Sponsor's protocol code numberFFM-CIK-CellStudy01
    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 SponsorGoethe-University Frankfurt
    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 supportrequested
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment for Children and Adolescents, University Hospital Frankfurt
    B.5.2Functional name of contact pointDivision Stem Cell Transplantation
    B.5.3 Address:
    B.5.3.1Street AddressTheodor-Stern-Kai 7
    B.5.3.2Town/ cityFrankfurt am Main
    B.5.3.3Post code60590
    B.5.3.4CountryGermany
    B.5.4Telephone number+49(0)696301-7542
    B.5.5Fax number+49(0)696301-4202
    B.5.6E-mailpeter.bader@kgu.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 Yes
    D.2.1.1.1Trade name Zytokin-aktivierte Killerzellen (CIK-Zellen), allogen
    D.2.1.1.2Name of the Marketing Authorisation holderDRK-B-SD BaWüHe
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameCIK-Cells
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    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) No
    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 No
    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
    relapsing acute leukemia, relapsing myelodysplastic syndromes
    E.1.1.1Medical condition in easily understood language
    Patients with acute leukemia or MDS showing evidence of relapse or hematologic relapse after allogeneic SCT.

    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 10000835
    E.1.2Term Acute leukemia
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level HLT
    E.1.2Classification code 10028536
    E.1.2Term Myelodysplastic syndromes
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety and feasibility of increasing cell doses of CIK cell transfusions in adult and pediatric leukemia and MDS patients with molecular, cytogenetic or hematologic relapse after allogeneic SCT.
    E.2.2Secondary objectives of the trial
    To assess the efficacy of CIK cell treatment based on:
    • Reduction or disappearance of MRD,
    • Achievement of complete donor chimerism,
    • Rate of and time to hematologic relapse in patients enrolled based on MRD and/or mixed chimerism, and
    • Rate and duration of complete hematologic response following CIK cell administration in patients enrolled with overt relapse
    • Progression-free and overall survival


    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Acute leukemia and MDS patients with cytogenetic relapse or detectable MRD in peripheral blood (PB) or bone marrow (BM) samples obtained during monitoring for relapse after allogeneic SCT. Increasing MRD levels or levels ≥ 10-4 of BCR-ABL/ABL ratio or Ig/TCR gene rearrangements will trigger CIK cell intervention in ALL patients.
    • Acute leukemia and MDS patients with MC ≥ 1% of autologous signals in PB samples confirmed by another PB or BM sample within one week. Patients with MC ≥ 1% of autologous signals in CD33+ and CD34+ subpopulations in PB samples confirmed by BM analyses within one week. Acute leukemia and MDS patients with MC ≥ 1% of autologous signals including signals in CD33+ and CD34+ subpopulations in BM samples.
    • Acute leukemia and MDS patients with hematologic relapse ≥ day 120 after allogeneic stem cell transplantation eligible for chemotherapy with less than 5% malignant cells in bone marrow analyses performed after cytoreductive chemotherapy. Re-induction chemotherapy regime will be offered per investigator`s choice.
    • Patients without immunosuppressive agents and steroids.
    • Patients without additional than pre-existing chemo- or immune modulatory therapy
    • Patients with < grade II GvHD.
    • Patients with karnowsky or lansky performance status ≥ 50%.
    •Patients and/or his/her legal representative having reviewed the patient information/informed consent form and have had their questions answered and have given written informed consent.
    E.4Principal exclusion criteria
    • Acute leukemia and MDS patients with hematologic relapse before day 120 or patients not eligible or without significant response to re-induction chemotherapy.
    • Patients with immunosuppressive agents or steroids.
    • Patients with additional than pre-existing chemo- or immune modulatory therapy
    • Patients with ≥ grade II GvHD.
    • Patients with karnowsky or lansky performance status < 50%.
    • Patients and/or his/her legal representative having reviewed the patient information/informed consent form and have had their questions answered and have not given written informed consent.
    E.5 End points
    E.5.1Primary end point(s)
    - The dose-limiting toxicity based on grade III or IV acute GvHD
    - Chronic limited and extensive GvHD

    E.5.1.1Timepoint(s) of evaluation of this end point
    variable
    E.5.2Secondary end point(s)
    - Molecular, cytogenetic or hematological response as efficacy end point
    - Progression free survival at 1 year after initiation of CIK cell therapy
    - Overall survival will be assessed 1 year after initiation of CIK cell therapy.

    E.5.2.1Timepoint(s) of evaluation of this end point
    after 1 year
    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 No
    E.8.1.1Randomised No
    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.8.3 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 concerned3
    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 No
    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
    LVLS
    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 months1
    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 Yes
    F.1.1Number of subjects for this age range: 20
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 2
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 8
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Trial subjects under the age of 18
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The treatment after the end of participation in the trial is not different from the expected normal treatment of that condition.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-28
    P. End of Trial
    P.End of Trial StatusOngoing
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