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    The EU Clinical Trials Register currently displays   38003   clinical trials with a EudraCT protocol, of which   6235   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:2010-022446-24
    Sponsor's Protocol Code Number:2011-01
    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:2012-05-23
    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 number2010-022446-24
    A.3Full title of the trial
    Active immunotherapy of patients with acute myeloid leukemia using autologous dendritic cells transfected with RNA encoding leukemia-associated antigens
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Therapeutic vaccination in patients with Acute Myeloid Leukemia
    A.3.2Name or abbreviated title of the trial where available
    DC vaccination for postremission therapy in AML
    A.4.1Sponsor's protocol code number2011-01
    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 SponsorHospital of the Ludwig Maximilians University Munich
    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 supportBayImmuNet
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportHelmholtz-Allianz Immuntherapie
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportHospital of the Ludwig Maximilians University of Munich
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMed. Klinik und Poliklinik III
    B.5.2Functional name of contact pointHead office
    B.5.3 Address:
    B.5.3.1Street AddressMarchioninistr. 15
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code81377
    B.5.3.4CountryGermany
    B.5.4Telephone number+498970952551
    B.5.5Fax number+498970955550
    B.5.6E-mailsekrmed3@med.uni-muenchen.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 nameAutologous DC
    D.3.2Product code DCs
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal 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) 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) 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
    Male and female patients with AML of non-favorable risk profile not eligible for allogeneic stem cell transplantation
    E.1.1.1Medical condition in easily understood language
    In AML bone marrow infiltration through myeloid blasts leads to insufficient function of leukocytes and low numbers of platelets and hemoglobin leading to life-threatening complications within days.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10000878
    E.1.2Term Acute myeloblastic 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
    Feasibility and safety of active immunotherapy with autologous DCs
    E.2.2Secondary objectives of the trial
    - Induction of immune responses
    - Control of minimal residual disease (MRD)
    - Clinical response: time to progression (TTP)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients male or female, age ≥ 18 years, biological age ≤ 75 years
    - Patients with AML of non-favorable risk profile or wit hAML and sole NPM1 mutation and confirmed increase of MRD load as detected by RQ-PCR (in two measurements at least four weeks apart)
    - CR or CRi, after intensive induction chemo-therapy (TAD, HAM, sHAM, 3+7 anthracycline + cytarabine regimen, or equivalent)
    - No concomitant chemotherapy until week 6 (minimum completion of 4 DC injections)
    - Negative HIV test (Anti-HIV-1,2-Ab), negative hepatitis B (HBs-Ag, Anti-HBc-Ab) and C (Anti-HCV-Ab) test (obtained within 7 days prior to study inclusion)
    - Negative pregnancy test in women of childbearing potential (obtained within 7 days prior to study inclusion)
    - Ability to understand and willingness to sign a written informed consent
    E.4Principal exclusion criteria
    - Patients suitable for allogeneic HSCT (indication for allogeneic HSCT, adequate donor, no contraindication for allogeneic HSCT)
    - Patients with AML with favorable risk profile:
    - APL (AML M3)
    - inv(16), t(16;16), or del(16) as sole anomaly
    - t(8;21) as sole anomaly
    - biallelic CEBPA mutation as sole anomaly
    - NPM1 mutation as sole anomaly, unless with confirmed increase of MRD load
    - Prior allogeneic HSCT
    - Leukopenia (< 4,0 G/l)
    - Anemia (Hb<9,0 g/dl)
    - Transfusion refractory thrombocytopenia (< 30 G/l platelets despite adequate number of transfusions); patients with thrombcytopenia between 30 and 50 G/l are required to be treated as inpatients
    - Active clinically relevant autoimmune disease
    - Active immunodeficiency syndromes
    - Known allergy to GM-CSF, TNF, IFN-γ, IL-4, PGE2, IL-1β, R848, human serum albumin, pooled human AB serum, DSMO, DPBS,or RPMI 1640
    - Continuous therapy with corticosteroids or other immunosuppressive drugs during the trial
    - Present substance abuse or any other factor that could limit the subject’s ability to comply with study procedures
    - Severe organ dysfunction:
    - Creatinine > 2,5 mg/ml
    - Bilirubin > 3,0 mg/ml
    - ALAT and ASAT > 3 x upper normal limit
    - Respiratory insufficiency with pO2 < 60 mmHg
    - Clinically relevant coronary heart disease of ventricular arrhythmia, congestive heart fail-ure > grade II NYHA
    - Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
    - Simultaneous participation in another clinical trial or participation in any clinical trial involving an investigational medicinal product within 30 days prior to written informed consent for this trial
    E.5 End points
    E.5.1Primary end point(s)
    1) % of grade I/II and grade III/IV toxicities
    2) % of patients in whom treatment with the scheduled number of immu-notherapies (10 DC vaccinations) is feasible
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) At all visits (V1-V10 + EOS)
    2) At EOS
    E.5.2Secondary end point(s)
    1) Immune responses to applied antigens
    2) Control of minimal residual disease
    3) Time to progression of disease
    4) ECOG performance status
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) At all visits (V1-V10 + EOS)
    2) At V5, V6, V7, V9 and EOS
    3) At EOS
    4) At all visits (V1-V10 + EOS)
    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 Yes
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    safety and toxicity
    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 No
    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 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
    End of the trial ist when the last patient has finished the last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state20
    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)
    Follow up after end of study is planned for 18 months. Follow up visits will be performed every 3 months. At each visit a medical history, a physical examination, a routine and a trial specific blood drawl and if applicable bone marrow aspiration will be performed. At the discretion of the patients, a follow-up observation until death will follow after the end of the study within the AML Registry of the SAL (Studienallianz Leukämie) and the AML-CG (AML Cooperative Group).
    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 Decision2013-09-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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