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    Summary
    EudraCT Number:2015-005817-61
    Sponsor's Protocol Code Number:iVAC-CLL01
    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:2016-04-13
    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 number2015-005817-61
    A.3Full title of the trial
    iVAC-CLL01: Patient-individualized peptide vaccination
    after first line therapy of CLL
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    iVAC-CLL01: Patient-individualized peptide vaccination
    after first line therapy of CLL
    A.3.2Name or abbreviated title of the trial where available
    iVAC-CLL01
    A.4.1Sponsor's protocol code numberiVAC-CLL01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02802943
    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 SponsorUniversity Hospital Tuebingen
    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 supportUniversity Hospital Tuebingen
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Tuebingen
    B.5.2Functional name of contact pointMedical Department II
    B.5.3 Address:
    B.5.3.1Street AddressOtfried-Mueller-Str. 10
    B.5.3.2Town/ cityTuebingen
    B.5.3.3Post code72076
    B.5.3.4CountryGermany
    B.5.4Telephone number+49 70712983275
    B.5.5Fax number+49 707129294391
    B.5.6E-mailhelmut.salih@med.uni-tuebingen.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 Aldara 5% Creme
    D.2.1.1.2Name of the Marketing Authorisation holderMeda AB
    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.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIMIQUIMOD
    D.3.9.1CAS number 99011-02-6
    D.3.9.4EV Substance CodeSUB12453MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) 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) 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.IMP: 2
    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 nameidiviualized peptide vaccine
    D.3.2Product code iVAC-CLL
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNindividualized peptide vaccine
    D.3.9.1CAS number 8000019-76-3
    D.3.9.2Current sponsor codeindividualized peptide vaccine
    D.3.9.3Other descriptive namePOLYPEPTIDE
    D.3.9.4EV Substance CodeSUB14950MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/µl microgram(s)/microlitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,6
    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 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
    Chronic lymphocytic leukemia (CLL) and small lymphocytic
    lymphoma (SLL) after first line therapy
    E.1.1.1Medical condition in easily understood language
    Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) after first line therapy
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10009310
    E.1.2Term CLL
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of this study is to induce a peptide-specific immune
    response in CLL patients by multi-peptide vaccination with a
    patient-individualized peptide cocktail.

    Primary endpoint:
    • Induction of peptide-specific T cell responses
    E.2.2Secondary objectives of the trial
    • Toxicity and Safety by CTCAE V4.03
    • Overall survival at the end of study
    • Disease free survival at the end of study
    • Remission status at the end of study
    • Achievement of MRD-negativity or reduction in MRD+
    patients

    • Overall survival, disease free survival, remission status
    for 5 years after the end of the study (off study)
    • Correlation of inducability of immune responses with
    clinical and biological patient characteristics
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Documented diagnosis of CLL/SLL according to IWCLL
    guidelines.
    For Screening phase:
    • No pretreatment of CLL/SLL
    • Ability to mount an immune response: Positive
    immunresponse to EBV/CMV peptide mix (analyzed
    in 12 day recall IFNγ ELISPOT).
    For Vaccination phase:
    • Achievement of response (at least PR according to
    IWCLL guidelines) after first-line therapy according
    to treating physicians choice.
    2. HLA typing positive for HLA alleles of peptides included in
    the warehouse with proven immunogenicity: HLA-A*01, A*02,
    A*03, A*24, B*07, B*08.
    3. Ability to understand and voluntarily sign an informed
    consent form.
    4. Age ≥ 18 years at the time of signing the informed consent
    form.
    5. Ability to adhere to the study visit schedule and other
    protocol requirements.
    6. Eastern Cooperative Oncology Group (ECOG) performance
    status score of ≤ 2.
    7. Negative serological Hepatitis B and C test or negative PCR
    in case of positive serological test without evidence of an
    active infection, negative HIV test within 6 weeks prior to
    randomization.
    E.4Principal exclusion criteria
    1. High risk CLL/SLL
    • 17p-deletion or
    • TP53 mutation
    2. Pregnant or lactating females.
    3. Participation in any clinical study or having taken any
    investigational therapy, which would interfere with the studys
    primary end point.
    4. Patients who have received any other vaccine within 1
    month prior to study inclusion.
    5. Prior history of malignancies, other than CLL, unless the
    subject has been free of the disease for ≥ 5 years. Exceptions
    include the following:
    • Basal cell carcinoma of the skin
    • Carcinoma in situ of the cervix
    • Carcinoma in situ of the breast
    • Incidental histological finding of prostate cancer (TNM
    stage of T1a or T1b)
    6. Any of the following laboratory abnormalities:
    For Vaccination phase:
    7. Disease transformation (active) (i.e. Richter’s Syndrome,
    prolymphocytic leukemia).
    8. Any immunosupressive treatment except corticosteroids.
    E.5 End points
    E.5.1Primary end point(s)
    • Induction of peptide-specific T cell responses
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary objective of this trial is to evaluate the immunogenicity of an individually composed multi-peptide vaccine as determined by induction of T cell immunity. The induction of peptide-specific T cell responses will be determined by IFNγ ELISPOT, intracellular cytokine staining and tetramer staining. These assays will be performed after obtaining and processing the last blood sample of each individual patient. All samples will be analyzed in parallel to limit interassay variability. In case of drop out of a patient from the study before 12 months after first vaccination, all so far available samples will be evaluated. Patients will be considered analysable when they received at least one vaccination.
    E.5.2Secondary end point(s)
    • Toxicity and Safety by CTCAE V4.03
    • Overall survival at the end of study
    • Disease free survival at the end of study
    • Remission status at the end of study
    • Achievement of MRD-negativity or reduction in MRD-positive patients
    • Overall survival, disease free survival, remission status and MRD level after 3 and 5 years
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary objectives of this trial are to evaluate the safety and toxicity of the individually composed multi-peptide. Toxicity will be determined by evaluation of the number of adverse events according to CTCAE V 4.03 (Appendix I) and the time schedule for individual vaccine composition.
    Further secondary objectives of this trial are the overall survival, the disease free survival and the remission status at the end of study as well as the evaluation of achievement of MRD-negativity or reduction in MRD-positive patients.
    For all patients participating in this study progression free survival and overall survival will be asseseds after 3 and 5 years outside the study protocol.
    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 Yes
    E.8.1.7.1Other trial design description
    Phase II multicentric open label interventional clinical trial, Patient stratification:MRD- and MRD+
    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 concerned5
    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
    The End of Study for a patient enrolled in this trial is defined as time of last follow-up at 6 months.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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) 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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 56
    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)
    A follow-up visit will be performed at minimum 30 days and 6 months following last vaccination. Follow up visits will include assessment of clinical and immunological efficacy as well as assessment of safty parameters according to table 2 in the investigator's protocol (iVAC-L-CLL-01; Version 1.0)
    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 Decision2016-07-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-21
    P. End of Trial
    P.End of Trial StatusOngoing
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