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    EudraCT Number:2017-002853-13
    Sponsor's Protocol Code Number:EWALL-BOLD
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-10-17
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2017-002853-13
    A.3Full title of the trial
    Phase II trial for the treatment of older patients with newly diagnosed CD19 positive, Ph/BCR-ABL negative B-precursor acute lymphoblastic leukemia with sequential dose reduced chemotherapy and Blinatumomab
    Phase II Studie für die Behandlung von älteren Patienten mit neu diagnostizierter CD19 positiver, Ph/BCR-ABL negativer B-Vorläufer akuter lymphatischer Leukämie mit sequenzieller dosisreduzierter Chemotherapie und Blinatumomab (EWALL-BOLD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study for older patients with CD19 positive, Ph/BCR-ABL negative B-precursor acute lymphoblastic leukemia treated with sequential dose reduced chemotherapy and Blinatumomab
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberEWALL-BOLD
    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 Universität Frankfurt
    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 supportAmgen Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGoethe Universität
    B.5.2Functional name of contact pointMedizinische Klinik II
    B.5.3 Address:
    B.5.3.1Street AddressTheodor-Stern-Kai 7
    B.5.3.2Town/ cityFrankfurt
    B.5.3.3Post code60590
    B.5.4Telephone number0049(0)6963016365
    B.5.5Fax number0049(0)6963017463
    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. name Blincyto
    D. of the Marketing Authorisation holderAmgen Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/09/650
    D.3 Description of the IMP
    D.3.1Product nameBlinatumomab
    D.3.4Pharmaceutical form Powder and solvent for concentrate for solution for 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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    D.3.11.9Recombinant medicinal product Yes
    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
    Patient aged 56 and 74 with CD19 positive, Ph/BCR-ABL negative B-precursor acute lymphoblastic leukemia
    E.1.1.1Medical condition in easily understood language
    Patients with acute lymphoblastic leukemia and aged between 56 and 74 years
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10066109
    E.1.2Term Precursor B-lymphoblastic leukemia acute
    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
    To evaluate the rate of complete hematologic remission after induction therapy
    E.2.2Secondary objectives of the trial
    To evaluate
    - the rate of complete remission (hematologic and molecular) after induction therapy
    - Overall survival at 1 year after start of therapy
    - Early mortality during induction therapy
    - MRD response rate and complete MRD response rate after induction and consolidation
    - Duration of MRD response and complete MRD response
    - Remission duration, relapse (disease) free survival and event-free survival
    - Role of stem cell transplantation
    - Relapse localisation
    - Quality of life of patients during induction and consolidation therapy
    - Safety and tolerability of induction and consolidation therapy
    - Treatment realisation (interruptions, dose reductions, treatment discontinuation)
    - Impact of pre-defined dose reductions and management recommendations
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Newly diagnosed patients with CD19 positive B–precursor ALL
    2. Greater than 25% blasts in the bone marrow
    3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
    4. Charlson comorbidity score ≤ 2
    5. Age >55 and <75 years at the time of informed consent*
    6. Renal and hepatic function as defined below:
    - AST (SGOT), ALT (SGPT), and AP < 5 x upper limit of normal (ULN) “(unless related to leukemic liver infiltration by investigator assessment)”
    - Total bilirubin < 1.5 x ULN (unless related to Gilbert's Meulengracht disease)
    - Creatinine < 1.5x ULN
    - Creatinine clearance > 50 mL/min (e.g. calculated according Cockroft & Gault)
    7. Negative pregnancy test in women of childbearing potential
    8. Ability to understand and willingness to sign a written informed
    9. For Germany: Participation in the registry of the German Multicenter Study Group for Adult ALL (GMALL)
    * in patients aged 75-76 years fulfilling all inclusion criteria without exclusion criteria and without relevant comorbidities the decision on inclusion can be discussed on an individual basis with the study coordination.
    E.4Principal exclusion criteria
    1. Antileukemic pretreatment (GMALL prephase with dexamethasone and cyclophosphamide allowed)
    2. History of malignancy other than ALL within 5 years prior to start of protocol-specified therapy with the exception of:
    − Malignancy treated with curative intent and with no known active disease present for 2 years before enrollment and felt to be at low risk for recurrence by the treating physician including
    − Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
    − Adequately treated cervical carcinoma in situ without evidence of disease
    − Adequately treated breast ductal carcinoma in situ without evidence of disease
    − Prostatic intraepithelial neoplasia without evidence of prostate cancer.
    3. History or presence of clinically relevant (per investigator's assessment) CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, or psychosis
    4. Active ALL in the CNS (confirmed by CSF analysis) or testes (clinical diagnosis) or other extramedullary involvement; non-bulky lymph node (< 7.5 cm diameter) involvement will be accepted.
    5. Current autoimmune disease or history of autoimmune disease with potential CNS involvement
    6. Known exclusion criteria to recommended chemotherapy
    7. Known positivity of HIV, hepatitis B (HbsAG) or hepatitis C virus (anti-HCV)
    8. Subject received prior anti-CD19 therapy
    9. Live vaccination within 2 weeks before the start of study treatment
    10. Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation
    − Currently receiving treatment in another investigational device or drug study or less than 30 days since ending treatment on another investigational device or drug study(s). Thirty days is calculated from day 1 of protocol-specified therapy
    − Subject has known sensitivity to immunoglobulins or any of the products or components to be administered during dosing.
    − Subject likely to not be available to complete all protocol-required study visits or procedures, including follow-up visits, and/or to comply with all required study procedures to the best of the subject and Investigator’s knowledge.
    − History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
    − Woman of childbearing potential and is not willing to use a highly effective method of contraception while receiving study treatment and for an additional 3 months after the last dose of study treatment.
    − Male who has a female partner of childbearing potential, and is not willing to use 2 highly effective forms of contraception while receiving protocol-specified therapy and for at least an additional 3 months after the last dose of protocol-specified therapy
    E.5 End points
    E.5.1Primary end point(s)
    - Proportion of patients achieving a complete hematologic remission after induction therapy defined as one cycle of chemotherapy and one cycle of Blinatumomab
    - Key-secondary endpoint: Rate of complete hematologic and complete molecular remission (MRD response or complete MRD response) after indution therapy defined as one cycle of chemotherapy and one cycle of Blinatumomab
    E.5.1.1Timepoint(s) of evaluation of this end point
    After induction therapy defined as one cycle of chemotherapy and one cycle of Blinatumomab (8 weeks of treatment)
    E.5.2Secondary end point(s)
    Secondary endpoints:
    - Probability of overall survival after 1 year
    - Rate and grade of adverse events (AE) according to CTC-AE in induction Phase I, blinatumomab induction and during CI, CII and CIII with blinatumomab
    - Proportion of patients who achieve an MRD response or a complete MRD response after induction and consolidation
    - Time to MRD relapse after prior achievement of MRD response or complete MRD response
    - Probability of continuous complete remission at 1 year
    - Probability of relapse free survival at 1 year
    - Probability of event-free survial at 1 year
    - Proportion of different relapse localisation in relation to total number of relapses
    - Quality of life measures (EORTC standard scales) at different time-points during induction and consolidation
    - Rate and duration of treatment interruptions, dose reductions, mitigation strategies and rate of withdrawals

    Exploratory endpoints:
    - Document and analyse hospitalisation time, use of infusion pump systems, use of ambulatory care services
    - Measurement of biologic markers in bone marrow and peripheral blood throughout induction and consolidation therapy
    E.5.2.1Timepoint(s) of evaluation of this end point
    18 months following initiation of Blinatumomab
    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. 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 concerned26
    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
    Prerequiste for termination of the trial is LVLS (i.e. End of Follow-up-period for the last patient) and completed data collection
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    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)
    According to standard of care.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation German Multicenter Study Group on Adult Acute Lymphoblastic Leukemia (GMALL)
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-01-10
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