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    Summary
    EudraCT Number:2015-000827-94
    Sponsor's Protocol Code Number:U-DANCE-anti-AML
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Not Authorised
    Date on which this record was first entered in the EudraCT database:2016-09-12
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2015-000827-94
    A.3Full title of the trial
    A phase I/II post cord blood HCT dendritic cells vaccination trial directed against WT1 for pediatric acute myeloid leukemia: the U-DANCE-anti-AML trial
    Een fase I/II onderzoek naar dendritische celvaccinatie tegen WT1 na een navelstrengbloed stamceltransplantatie in kinderen met Acute Myeloide Leukemie: het U-DANCE-tegen-AMLonderzoek
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    U-DANCE-anti-AML
    U-DANCE-tegen-AML
    A.3.2Name or abbreviated title of the trial where available
    U-DANCE-anti-AML
    U-DANCE-tegen-AML
    A.4.1Sponsor's protocol code numberU-DANCE-anti-AML
    A.5.4Other Identifiers
    Name:Dutch Competent authorityNumber:NL52641
    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 SponsorUMC Utrecht
    B.1.3.4CountryNetherlands
    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 support-NWO (ZonMW), KiKa
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUMC Utrecht
    B.5.2Functional name of contact pointJ.J. Boelens, MD, PhD
    B.5.3 Address:
    B.5.3.1Street AddressHeidelberglaan 100
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3584 CX
    B.5.3.4CountryNetherlands
    B.5.4Telephone numberNeder887554003
    B.5.5Fax number887554003
    B.5.6E-mailj.j.boelens@umcutrecht.nl
    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.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameWT1-loaded CBDC vaccine
    D.3.4Pharmaceutical form Concentrate and solvent for solution for injection
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPIntradermal use
    Intravenous 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
    AML: Acute Myeloid leukemia/ cancer of blood and bone marrow
    AML: Acute Myeloide Leukemie/ kanker van het bloed en beenmerg
    E.1.1.1Medical condition in easily understood language
    AML: Acute Myeloid leukemia/ cancer of blood and bone marrow
    AML: Acute Myeloide Leukemie/ kanker van het bloed en beenmerg
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10000886
    E.1.2Term Acute myeloid leukemia
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10000887
    E.1.2Term Acute myeloid leukemia in remission
    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
    This study will be subdivided into 2 parts:
    -Part A: to determine a safe dose of the vaccination, and
    -Part B: to study its activity measured as the one-year relapse-free survival rate, based on an expansion cohort.


    -Part A; primary objective:
    - To assess the safe dose for CBDC vaccination after CBT, defined by the occurrence of dose limiting toxicities (DLTs), including acute graft versus host disease (aGVHD). The DLT evaluation period lasts from the first vaccination until 84 days after the third CBDC vaccination.

    -Part B primary objective:
    - To demonstrate an increase in the WT1+ AML relapse-free survival rate using a WT1-loaded CBDC vaccine, at one year after the first vaccination (using a historic cohort not receiving a CBDC vaccination as reference data for the Simon-2-stage design).
    E.2.2Secondary objectives of the trial
    Part A: secondary objectives:
    - To assess the safety and tolerability of the vaccination strategy
    - To assess the induction/increase of WT1-specific immunity in vaccinated individuals during one year of follow-up from the first vaccination
    - To assess overall survival at one year after the first vaccination
    - To assess WT1+ AML relapse-free survival at one year after the first vaccination
    -To assess the chronic GvHD (cGvHD) occurrence during one year of follow-up from the first vaccination

    Part B: secondary objectives:
    - To assess the safety and tolerability of the vaccination strategy
    - To assess the induction/increase of WT1-specific immunity in vaccinated individuals during one year of follow-up from the first vaccination
    - To assess the overall survival at one year after the 1st vaccination
    - To assess the cGvHD occurrence during one year of follow-up from the first vaccination (as compared to our historic cohort not receiving a CBDC vaccination).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Pediatric AML patients eligible for allo-HCT according to standard-of-care guidelines, with overexpression of WT1 mRNA in an AML sample (>50 copies WT1/10^4 copies ABL for PB, and >250 copies WT1/10^4 copies ABL for BM) 52 taken at diagnosis and/or relapse after (re-)induction chemotherapy.
    -Indication for CB-HCT according to the UMC Utrecht guidelines
    -CB selection criteria: the 80% fraction of the unit should contain a minimum total nucleated cell number of 3x10^7 NC/Kg criteria for any match grade (before cryo-preservation). Preferable CD34+/Kg dose: > 1x10e5 in the 80% fraction
    -The whole CB unit should contain more than 7.5x10^6 total CD34+ before freeze.
    -Karnofsky/Lansky score ≥70 (annex 1)
    -Age limits for part A (safety run) only: ≥12 and ≤17 years of age, and <18 years for part B of the study.
    -Signed informed consent
    E.4Principal exclusion criteria
    Subject who meets any of the following criteria will be excluded from participation in this study:
    -Patients undergoing allo-HCT with stem cells derived from PBMCs or BM
    -Patients who are pregnant or breast-feeding or unwilling to use adequate contraceptive methods
    -Known allergies to compounds used in the CBDC production process or the local anesthetic “lidocaine-tetracaine (Rapydan®) plasters
    -Patients included in other intervention studies influencing the endpoints of this study
    E.5 End points
    E.5.1Primary end point(s)
    Part A: Safety: Occurrence of DLTs including aGvHD (according to Glucksberg criteria 1) from the first vaccination (t=0) until 84 days after the third CBDC vaccination

    Part B: Activity: One-year WT1+ AML relapse-free survival rate from the time of the first vaccination as compared to historic controls.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary endpoints
    A) Dose-limiting toxicities (DLTs) will be scored according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, and aGvHD is scored according to the Gluckberg criteria 1
    B) WT1+ MRD and relapses are monitored, predicted and confirmed by assessing the WT1 mRNA levels in PB samples (1 ml) by U-DAIR (UMC Utrecht) as specified in the laboratory manual.
    E.5.2Secondary end point(s)
    Secondary Endpoints, Part A and Part B:
    - One-year cumulative increase of WT1-specific immunity defined by:

    -In vitro T cell reactivity towards MHC class I and II-restricted WT1 epitopes by multiplex-cytokine assay and flow cytometric analysis of CD8/CD137 and CD4/CD154 expression by PBMCs stimulation with WT1 peptivator (Miltenyi).
    -Quantitative and qualitative FACS analysis of WT1-specific-positive CD8+ T cells using HLA-A2 multimers against a wide range of possible WT1 peptides. The multimers are made using the conditional MHC class I ligands and peptide exchange technology currently available for the human MHC gene products HLA-A1, -A2, -A3, -A11, and -B772
    - One-year cumulative incidence of cGvHD (according to NIH criteria2) from the first vaccination until one year of follow-up
    - One-year overall survival rate from the time of first vaccination
    - One-year WT1+AML relapse-free survival rate, from the time of first vaccination

    Exploratory Endpoints, Part A and Part B:
    - Changes in general immune parameters between those samples taken before and those taken after the first vaccination until one year of follow-up:
    -T cells (naïve, central memory, effector, effector memory resting or activated CD4, CD8 and gamma/delta TCR)
    -Regulatory T cells (CD3/CD4/CD127/CD25/FoxP3)
    -T helper subsets (Th1, Th2, Th17, Th22, follicular helper cells)
    -B cells (naïve, memory, transitional, plasmablasts)
    -NK/NKT cells (CD16/CD56, CD3, Va24/Vb11)
    -Dendritic cell/monocytes (classical, intermediate, non-classical monocytes and BDCA1, BDCA3 and plasmacytoid DCs

    - Expression of inhibitory (immune checkpoint) molecules on the AML in the case of relapse occurring after the first vaccination until one year of follow-up
    E.5.2.1Timepoint(s) of evaluation of this end point
    -One-year cumulative incidence of WT1-specific immunity (cellular + humoral immunity against WT1 antigen: as specified in laboratory manual) as measured using 5 ml of PB by U-DAIR (UMC Utrecht) using:
    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) Yes
    E.7.1.1First administration to humans Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    historisch cohort van 17 AML patienten (getransplanteerd tussen 2010-2015)
    historic cohort of 17 AML patients (transplanted between 2010-2015)
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    laatste patiënt laatste visite
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 54
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 5
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 22
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 27
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 state54
    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)
    none
    geen
    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 Decision2016-09-08
    N.Ethics Committee Opinion of the trial applicationNot-Favourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-25
    P. End of Trial
    P.End of Trial StatusNot Authorised
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