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    The EU Clinical Trials Register currently displays   44309   clinical trials with a EudraCT protocol, of which   7356   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:2007-006301-24
    Sponsor's Protocol Code Number:06/143
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-12-28
    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 ConcernedUK - MHRA
    A.2EudraCT number2007-006301-24
    A.3Full title of the trial
    MULTI CENTRE CONTROLLED STUDY ON THE IMPACT OF STEM CELL DONATION EITHER AFTER MOBILISATION WITH GRANULOCYTE COLONY STIMULATING FACTOR OR BONE MARROW HARVEST ON UNRELATED BONE MARROW DONORS
    A.3.2Name or abbreviated title of the trial where available
    Study on the Impact of Stem Cell Donation and Bone Marrow Harvesting on Unrelated Donors
    A.4.1Sponsor's protocol code number06/143
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity College London, Joint Research Office
    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 supportChugai-Pharma Ltd
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportAmgen
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportAnthony Nolan Trust
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportBritish Bone Marrow Registry
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportNational Marrow Donor Program
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity College London
    B.5.2Functional name of contact pointGCSF Clinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressUCL, Cancer Institute, Academic Haematology, Hampstead Campus, Rowland Hill Street
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeNW3 2QG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number4402074726176
    B.5.6E-maile.nacheva@ucl.ac.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 Yes
    D.2.1.1.1Trade name GRANOCYTE
    D.2.1.1.2Name of the Marketing Authorisation holderCHUGAI PHARMA UK
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLENOGRASTIM
    D.3.9.1CAS number 135968-09-1
    D.3.9.4EV Substance CodeSUB02888MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/kg microgram(s)/kilogram
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Study on the impact of stem cell donation either after mobilisation with granulocyte colony stimulating factor (GCSF) or bone marrow harvest on unrelated donors.
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10051716
    E.1.2Term Peripheral blood stem cell apheresis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    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 two fold
    a) Detection of any genetic differences between bone marrow and PBSC unrelated donors, 3-5 years post donation and confirm or refute the observations of “long-term genetic or epigenetic effects” published by Nagler et al. (completed – none detected see below)
    b) Screen and compare PBSC donors lymphocytes pre and up to 6 months post G-CSF exposure to detect any ‘short-term’ genetic changes also described by Nagler et al. The employment of more sensitive methods such as iFISH and gene array analysis to assess any permanent genetic changes, our primary objective, will make our study more robust.
    E.2.2Secondary objectives of the trial
    NONE
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pre-existing healthy volunteer unrelated donors (who have met strict and extensive entry criteria) on the Anthony Nolan and British Bone Marrow Registries.

    Aged 18-60 years.

    Minimum weight 51 Kgs.

    Participants in the prospective arm are able to undergo peripheral blood collection (apheresis)
    E.4Principal exclusion criteria
    Pregnant or breastfeeding female.

    Family history of haematological malignance.

    Any related donor.

    Previously donated bone marrow or PBSC's

    Hypersensitive to Lenograstim (or its excipients; arginine, phenlanine, methionine, mannitol (E421) or polysorbate 20).

    Weight under 51 Kgs.
    E.5 End points
    E.5.1Primary end point(s)
    The binary variable genetic change i.e. clonal aberrations detected in any one of chromosomes 7, 8 and 17.


    E.5.1.1Timepoint(s) of evaluation of this end point
    There will be two arms:

    iii) Retrospective arm – time points 3 to 5 years post donation. (completed)

    iv) Prospective arm - Peripheral blood of 50 unrelated PBSC donors only will be examined at the following time points: prior to donation and before exposure to G-CSF (minus 2-3 wks); at donation and after exposure to G-CSF at Day 0 (on the day of Apheresis) and Day 90 +/- 14 days and Day 180 +/- 14 days post-donation.
    E.5.2Secondary end point(s)
    none
    E.5.2.1Timepoint(s) of evaluation of this end point
    none
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    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 Information not present in EudraCT
    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 Trial shall end when the last sample has been collected from the last trial subject and the analysis of all samples has been completed.
    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 months6
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 150
    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 Yes
    F.3.2Patients No
    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 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 state150
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 150
    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 Decision2008-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-05-20
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