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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2012-000793-30
    Sponsor's Protocol Code Number:IntReALL-SR-2010
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2012-12-19
    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 ConcernedUK - MHRA
    A.2EudraCT number2012-000793-30
    A.3Full title of the trial
    International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    International Study for Treatment of Standard Risk Childhood Relapsed Acute Lymphoblastic Leukemia 2010
    A.3.2Name or abbreviated title of the trial where available
    IntReALL SR 2010
    A.4.1Sponsor's protocol code numberIntReALL-SR-2010
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01802814
    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 SponsorCharité - University Hospital of Berlin
    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 supportEU Project FP7
    B.4.2CountryEuropean Union
    B.4.1Name of organisation providing supportImmunomedics
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCharité - University Hospital of Berlin
    B.5.2Functional name of contact pointDr. Arend von Stackelberg
    B.5.3 Address:
    B.5.3.1Street AddressAugustenburger Platz
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13353
    B.5.3.4CountryGermany
    B.5.4Telephone number+49 030 450666833
    B.5.5Fax number+49 030 450566903
    B.5.6E-mailarend.stackelberg@charite.de
    B.Sponsor: 2
    B.1.1Name of SponsorManchester University NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 supportEU Project FP7
    B.4.2CountryEuropean Union
    B.4.1Name of organisation providing supportImmunomedics
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationManchester University NHS Foundation Trust
    B.5.2Functional name of contact pointLynne Webster
    B.5.3 Address:
    B.5.3.1Street AddressResearch Office, 1st Floor Nowgen Building, 29 Grafton Street
    B.5.3.2Town/ cityManchester
    B.5.3.3Post codeM139WU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01612763565
    B.5.6E-maillynne.webster@mft.nhs.uk
    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 nameEpratuzumab
    D.3.2Product code IMMU-103
    D.3.4Pharmaceutical form Solution for 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.3.8INN - Proposed INNEpratuzumab
    D.3.9.1CAS number 205923-57-5
    D.3.9.2Current sponsor codeEpratuzumab
    D.3.9.3Other descriptive nameEPRATUZUMAB
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    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 Yes
    D.3.11.13.1Other medicinal product typeHumanized monoclonal antibody
    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
    Acute lymphoblastic leukemia (ALL)
    E.1.1.1Medical condition in easily understood language
    Acute lymphoblastic leukemia (ALL)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10063626
    E.1.2Term Acute lymphocytic leukemia recurrent
    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
    1. Does ALL R3 (arm B) therapy improve outcome compared to ALLREZ BFM 2002 (arm A) therapy for all patients?
    2. Does the addition of Epratuzumab improve outcome?
    E.2.2Secondary objectives of the trial
    1. Does Arm B clear disease during induction chemotherapy more quickly than Arm A?
    2. Do more patients on Arm B undergo SCT than in Arm A?
    3. Is Arm B more toxic than Arm A?
    4. Is toxicity greater in patients receiving Epratuzumab?
    5. Does epratuzumab lower MRD levels?
    6. Does Arm B result in more MRD negativity before SCT than in Arm A?
    7. Does epratuzumab affect the rate of MRD negativity before SCT?
    8. Compare the pharmacokinetics of epratuzumab in Arm A and B
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell ALL
    • Children less than 18 years of age at inclusion
    • Meeting SR criteria: late isolated or late/early combined B Cell Precursor BM relapse, any late/early isolated extramedullary relapse
    • Patient enrolled in a participating centre
    • Written informed consent
    • Start of treatment falling into the study period
    • No participation in other clinical trials 30 days prior to study enrolment that interfere with this protocol, except trials for primary ALL

    Inclusion criteria specific for the epratuzumab randomization:
    • Precursor B-cell immunophenotype. A specific CD22 expression level is not required
    • M1 or M2 status of the bone marrow after induction
    E.4Principal exclusion criteria
    • BCR-ABL / t(9;22) positive ALL
    • Pregnancy or positive pregnancy test (urine sample positive for β-HCG > 10 U/l)
    • Sexually active adolescents not willing to use highly effective contraceptive method (pearl index <1) until 2 years after end of antileukemic therapy
    • Breast feeding
    • Relapse post allogeneic stem-cell transplantation
    • The whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian
    • No consent is given for saving and propagation of pseudonymized medical data for study reasons
    • Severe concomitant disease that does not allow treatment according to the protocol at the investigator’s discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders)
    • <exclusion criterion removed from protocol v1.91>
    • Subjects unwilling or unable to comply with the study procedures
    • Subjects who are legally detained in an official institute
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome of Event free survival (EFS1) for the ALLR3/ALL-REZ BFM 2002 randomisation is defined as the time from randomisation to the first of induction failure, relapse, death from any cause or second malignancy, or is censored at the date of last follow-up. Note that SCT is not considered as event and is also not censored in the EFS1 analyses.

    The primary outcome of Event free survival (EFS2) for the epratuzumab/no eprratuzumab randomisation is defined as the time from randomisation to the first of persisting non-response, progression, death from any cause or second malignancy, or is censored at the date of last follow-up. Note that for SR2 analysis, M0 or M3 patients at the start of consolidation and induction failures will be off study and not included in the analysis. Note that SCT is not considered as event and is also not censored in the EFS2 analyses.
    E.5.1.1Timepoint(s) of evaluation of this end point
    - at 4 years of arm A
    - at 4 years of standard arm
    E.5.2Secondary end point(s)
    - SR induction/consolidation: comparison of OS, toxicity, rate of CR2, and rate of MRD between treatment groups
    - SR consolidation +/- epratuzumab: comparison of OS, toxicity, MRD levels, rate of MRD and evaluation of pharmacokinetic parameters of Epratuzumab
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the study
    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 Yes
    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) 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned20
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA198
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    Belgium
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Ireland
    Israel
    Italy
    Japan
    Netherlands
    New Zealand
    Norway
    Poland
    Portugal
    Spain
    Sweden
    Switzerland
    United Kingdom
    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
    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
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days30
    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: 1243
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 25
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 845
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 373
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects under age incapable of giving consent personally.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state160
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 612
    F.4.2.2In the whole clinical trial 1242
    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)
    Post trial treatment is not different from the expected normal treatment of this condition.

    After termination of the study, patients will be followed up by national children’s cancer registries to capture safety relevant late effects, secondary malignancies and to have the opportunity to give the feedback to the patients, if necessary. Patients who are off study continue to be observed including a report of death in order to allow the assessment of overall survival.
    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 Decision2013-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-31
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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