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    The EU Clinical Trials Register currently displays   44293   clinical trials with a EudraCT protocol, of which   7351   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2012-002879-34
    Sponsor's Protocol Code Number:PSCT16
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-08-24
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-002879-34
    A.3Full title of the trial
    Vaccination with minor histocompatibility antigen-loaded donor DC vaccines to boost graft-versus-tumor immunity after allogeneic stem cell transplantation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dendritic cells vaccination after allogeneic stem cell transplantation
    A.3.2Name or abbreviated title of the trial where available
    MiHA-loaded DC vaccination after allogeneic SCT
    A.4.1Sponsor's protocol code numberPSCT16
    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 SponsorRadboud University Nijmegen Medical Centre
    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 supportKWF
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboud University Nijmegen Medical Centre
    B.5.2Functional name of contact pointTrial Data Center
    B.5.3 Address:
    B.5.3.1Street AddressTheodoor Craanenlaan 1
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525 GH
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31243614794
    B.5.5Fax number31243668205
    B.5.6E-mailDatacentrum@HEMAT.umcn.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.2.5The 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 nameMiHA-TC-DC product
    D.3.2Product code MiHA-TC-DC product
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameMiHA mRNA transfected Dendritic Cell product
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5x105/kg
    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) 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
    Patients with aggressive hematological malignancies treated with allogeneic stem cell transplantation
    E.1.1.1Medical condition in easily understood language
    Patients with aggressive hematological cancers treated with allogeneic stem cell transplantation
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of our study are to evaluate safety, toxicity and capability of inducing T cell responses of vaccination with monocyte-derived donor DC electroporated with mRNA encoding hematopoietic-restricted MiHA in patients who had undergone allo-SCT with stem cells from HLA-matched, MiHA-mismatched donor.
    E.2.2Secondary objectives of the trial
    The secondary objective is to evaluate the clinical effect of vaccination in case of detectable minimal residual disease and mixed chimerism.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients with AML, myelodysplasia (MDS), ALL, CML (accelerated or blast phase), CLL, MM or malignant NHL, who underwent HLA-matched allo-SCT
    • Patients positive for HLA-A2, HLA-A24, HLA-B7 and/or HLA-B44
    • Patients positive for HA-1, LRH-1 and/or ARHGDIB transplanted with corresponding MiHA-negative donor
    • Patients >18 and <65 years of age
    • WHO performance 0-2
    E.4Principal exclusion criteria
    • Life expectancy < 3 months
    • Severe neurological or psychiatric disease
    • Progressive disease needing cytoreductive therapy
    • HIV positivity
    • Patients with acute GVHD grade 3 or 4
    • Patients with extensive chronic GVHD
    • Patients with active infections (viral, bacterial or fungal) that requires specific therapy. Acute anti-infectious therapy must have been completed within 14 days prior to study treatment
    • Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease
    • Severe pulmonary dysfunction (CTCAE III-IV)
    • Severe renal dysfunction (serum creatinine > 3 times normal level)
    • Severe hepatic dysfunction (serum bilirubin or transaminases > 3 times normal level)
    • Patients with known allergy to shell fish
    E.5 End points
    E.5.1Primary end point(s)
    The primary study parameters are to evaluate the safety, toxicity, development of GVHD and the immunological response by appearance of MiHA-specific CD8+ T cells following vaccination with monocyte-derived donor DC electroporated with mRNA encoding hematopoietic-restricted MiHA in patients who had undergone allo-SCT with stem cells from HLA-matched, MiHA-mismatched donor.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Participating patients will visit the outpatient clinic weekly or two-weekly for standard physical examination and blood sampling from the first DC vaccination until 4 and 12 weeks after vaccination, respectively. For follow-up, peripheral blood will be collected from patients pre-study, at day 0, 7, 14, 21, 28, 42, 63 and 84 during and after DC vaccinations. The total amount of blood that will be taken for study purposes will be maximally 282 ml in a three month period. Two extra bone marrow aspirations will be performed (day 42 and 84 after first DC vaccination).
    E.5.2Secondary end point(s)
    The secondary study parameters are to evaluate the clinical effect of MiHA-DC vaccination in case of detectable minimal residual disease and mixed chimerism.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Participating patients will visit the outpatient clinic weekly or two-weekly for standard physical examination and blood sampling from the first DC vaccination until 4 and 12 weeks after vaccination, respectively. For follow-up, peripheral blood will be collected from patients pre-study, at day 0, 7, 14, 21, 28, 42, 63 and 84 during and after DC vaccinations. The total amount of blood that will be taken for study purposes will be maximally 282 ml in a three month period. Two extra bone marrow aspirations will be performed (day 42 and 84 after first DC vaccination).
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 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 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
    Last visit of the last subject is day 84 after start study last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 10
    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 state10
    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
    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 Decision2012-08-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-05
    P. End of Trial
    P.End of Trial StatusCompleted
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