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    Summary
    EudraCT Number:2020-003994-23
    Sponsor's Protocol Code Number:DagainstGVH
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-04
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-003994-23
    A.3Full title of the trial
    Role of Vitamin D in GVHD prophylaxis in patients undergoing allogeneic stem cell transplantation. Randomized single-center pilot study
    Ruolo nella profilassi di GVHD della Vitamina D in pazienti sottoposti a trapianto allogenico di cellule staminali. Studio Pilota randomizzato monocentrico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Role of Vitamin D in patients undergoing allogeneic stem cell transplantation. Pilot study
    Ruolo della Vitamina D in pazienti sottoposti a trapianto allogenico di cellule staminali. Studio Pilota
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberDagainstGVH
    A.5.4Other Identifiers
    Name:-Number:-
    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 SponsorAZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
    B.1.3.4CountryItaly
    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 supportSPA Società Prodotti Antibiotici
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Ospedaliero Universitaria Pisana
    B.5.2Functional name of contact pointU.O. Ematologia Univ
    B.5.3 Address:
    B.5.3.1Street AddressVia Roma, 67
    B.5.3.2Town/ cityPisa
    B.5.3.3Post code56126
    B.5.3.4CountryItaly
    B.5.4Telephone number050993085
    B.5.5Fax number050993488
    B.5.6E-mailmario.petrini@ao-pisa.toscana.it
    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 TREDIMIN
    D.2.1.1.2Name of the Marketing Authorisation holderSPA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameTREDIMIN
    D.3.2Product code [042753121]
    D.3.4Pharmaceutical form Oral drops
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCOLECALCIFEROLO
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive namevitamina D3
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25000
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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.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
    Treatment of acute and chronic graft versus host disease (GVHD) after allogeneic donor hematopoietic stem cell transplantation in adult patients with haematological diseases.
    Trattamento della malattia del trapianto verso l'ospite (GVHD) acuta e cronica dopo trapianto di cellule staminali emopoietiche da donatore allogenico in pazienti adulti con malattie ematologiche.
    E.1.1.1Medical condition in easily understood language
    Treatment of graft versus host disease after stem cell graft from donor genetically different from recipient
    Trattamento della malattia del trapianto contro l'ospite dopo innesto di cellule staminali da donatore geneticamente differente dal ricevente
    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 10068908
    E.1.2Term AGVHD
    E.1.2System Organ Class 100000004870
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Reduction in the severity of acute and chronic GvHD in patients treated with Vitamin D compared to the control group
    Riduzione della severità della GvHD acuta e cronica nei pazienti trattati con Vitamina D rispetto al gruppo di controllo
    E.2.2Secondary objectives of the trial
    Evaluation of lymphocyte subsets circulating on peripheral blood
    Evaluation of the surface expression of the vitamin D receptor (VDR) and modulation in response to treatment with vitamin D on lymphocyte subpopulations
    Evaluation of the soluble fraction of the VDR on serum
    Post hoc evaluation of the role of polymorphisms (SNPs) of the recipient and donor VDR on the response to vitamin D therapy
    - Valutazione delle sottopopolazioni linfocitarie circolanti su sangue periferico
    - Valutazione dell’espressione superficiale del recettore della vitamina D (VDR) e modulazione in risposta al trattamento con vitamina D su sottopopolazioni linfocitarie
    - Valutazione della frazione solubile del VDR su siero
    - valutazione post hoc del ruolo di polimorfismi (SNP) del VDR del ricevente e del donatore sulla risposta alla terapia con vitamina D
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - age > 18 years old
    - Diagnosis of any oncohematological pathology with transplant indication; patients not in clinical response allowed
    - Patients undergoing allogeneic stem cell transplantation regardless of the conditioning regimen and source of CSE
    - ability to sign informed consent
    - Età > 18 anni
    - Diagnosi di qualsiasi patologia oncoematologica con indicazione trapiantologica, consentiti pazienti anche non in risposta clinica
    - Pazienti sottoposti a trapianto di cellule staminali allogeniche indipendentemente dal regime di condizionmameneto e della fonte di CSE
    - Capacità di firmare il consenso informato
    E.4Principal exclusion criteria
    - Transplant from T-depleted or T-selected product
    - Documented intolerance to the drug or to one of its excipients;
    - Ongoing vitamin D therapy for any medical conditions;
    - Hypercalcemia, hypercalciuria, kidney stones, renal failure;
    - age < 18 years
    - Subjects who are not legally deemed capable of understanding and willing.
    - Trapianto da prodotto T-depleto o T-selezionato;
    - Intolleranza documentata al farmaco o ad uno dei suoi eccipienti;
    - Terapia in corso con vitamina D per qualsiasi condizioni medica;
    -Ipercalcemia, ipercalciuria, calcolosi renale, insufficienza renale;
    - Età < 18 anni
    - Soggetti che non siano ritenuti legalmente capaci di intendere e di volere.
    E.5 End points
    E.5.1Primary end point(s)
    Evaluate the effectiveness of vitamin D in GVHD in terms of presentation and severity.
    Valutare l’efficacia della vitamina D nella GVHD in termini di presentazione e severità.
    E.5.1.1Timepoint(s) of evaluation of this end point
    18 months
    18 mesi
    E.5.2Secondary end point(s)
    - Evaluation of lymphocyte subsets circulating on peripheral blood
    - Evaluation of the surface expression of the vitamin D receptor (VDR) and modulation in response to treatment with vitamin D on lymphocyte subpopulations.
    - Evaluation of the soluble fraction of VDR on serum
    - Post hoc evaluation of the role of polymorphisms (SNPs) of the recipient and donor VDR on the response to vitamin D therapy
    - Valutazione delle sottopolazioni linfocitarie circolanti su sangue periferico
    - Valutazione dell’espressione superficiale del recettore della vitamina D (VDR) e modulazione in risposta al trattamento con vitamina D su sottopopolazioni linfocitari.
    - valutazione della frazione solubile del VDR su siero
    - valutazione post hoc del ruolo di polimorfismi (SNP) del VDR del ricevente e del donatore sulla risposta alla terapia con vitamina D
    E.5.2.1Timepoint(s) of evaluation of this end point
    18 mesi
    18 mesi
    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 No
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    somministrazione di sola terapia astandard (terapia immunosoppressiva)
    standard of care administration only (immunosuppressive therapy)
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 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
    Enorollment will be concluded when the target number of twenty patients is reached.
    Each patient will be under a twelve months transplant of follow up and then the study is cocluded
    L’arruolamento verrà concluso in caso di raggiungimento del numero previsto di 20 pazienti.
    Ogni paziente avrà un follow up di 12 mesi post trapianto e quindi terminerà lo studio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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)
    At the end of clinical trial, patients will be treated as per normal clinical practice while continuing the background therapy
    Al termine della partecipazione allo studio i pazienti saranno trattati come da normale pratica clinica continuando la terapia di background
    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 Decision2021-04-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-09
    P. End of Trial
    P.End of Trial StatusOngoing
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