Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-000722-26
    Sponsor's Protocol Code Number:AVM-003-HC
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-09-21
    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 ConcernedSweden - MPA
    A.2EudraCT number2020-000722-26
    A.3Full title of the trial
    Phase 3 Multicenter, Double-Blind, Placebo-Controlled Trial of Viralym-M (ALVR105) for the Treatment of Patients With Virus-Associated Hemorrhagic Cystitis After Allogeneic Hematopoietic Cell Transplant
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research study conducted to determine if ALVR105 is safe and a good treatment for hemorrhagic cystitis (HC) caused by a viral infection after allogeneic hematopoietic cell transplant (HCT).
    A.4.1Sponsor's protocol code numberAVM-003-HC
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04390113
    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 SponsorAlloVir, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAlloVir, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlloVir, Inc.
    B.5.2Functional name of contact pointClinical Trials Information Line
    B.5.3 Address:
    B.5.3.1Street Address1100 Winter Street
    B.5.3.2Town/ cityWaltham, Massachusetts
    B.5.3.3Post code02451
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1(833)409-2281
    B.5.6E-mailclinicaltrials@allovir.com
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/20/2260
    D.3 Description of the IMP
    D.3.1Product namePosoleucel (ALVR105)
    D.3.4Pharmaceutical form Dispersion 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 INNPosoleucel
    D.3.9.2Current sponsor codeALVR105
    D.3.9.3Other descriptive nameAllogeneic multi-virus specific T lymphocytes targeting BK Virus, cytomegalovirus, human herpes virus-6, Epstein Barr virus and adenovirus
    D.3.9.4EV Substance CodeSUB197084
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1 × 10^7
    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) No
    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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboDispersion for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Virus-Associated Hemorrhagic Cystitis After Allogeneic Hematopoietic Cell Transplant.
    E.1.1.1Medical condition in easily understood language
    Inflammation of the bladder caused by viral infection following bone marrow transplant.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10059348
    E.1.2Term Viral hemorrhagic cystitis
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the time to resolution of macroscopic hematuria in recipients of Posoleucel (PSL) to that in recipients of placebo.
    E.2.2Secondary objectives of the trial
    1) To compare the time to resolution of bladder pain as measured by Clinical Outcome Assessments (COAs) in recipients of PSL to that in recipients of placebo.
    2) To assess number of days in the hospital.
    3) To assess the incidence and severity of acute graft versus host disease (GVHD) and cytokine release syndrome (CRS)
    4) To assess time to resolution of viremia for all target viruses.
    5) To assess average daily bladder pain.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants must meet all of the following criteria in order to be eligible to participate in the study:
    1. Male or female but enrollment of participants <1 year of age at the time of informed consent will occur only once preliminary safety data are available from 5 participants ≥1 and ≤6 years of age.
    2. Had an allogeneic hematopoietic cell transplant (HCT) performed ≥ 21 days and ≤ 1 year prior to randomization.
    3. Myeloid engraftment confirmed.
    4. Diagnosed with Hemorrhagic Cystitis.
    5. At least 1 identified, suitably matched PSL cell line for infusion is available.
    6. Willing and able to provide written informed consent to participate in the study, or a parent or legal guardian is willing and able to provide written informed consent and the potential pediatric patient is able to provide assent in a manner approved by the Institutional Review Board/Independent Ethics Committee and local regulations.
    7. Women of childbearing potential (WOCBP) and men whose sexual partners are WOCBP must agree to use contraception during the study and for a minimum of 90 days after study treatment; participants must also refrain from donating sperm or eggs during the study and for at least 90 days after treatment completion.
    8. Has a negative serum pregnancy test for female participants of childbearing potential.
    E.4Principal exclusion criteria
    Participants who meet any of the following criteria will be excluded from participation in the study:
    1. Ongoing therapy with high-dose systemic corticosteroids.
    2. Therapy with antithymocyte globulin, alemtuzumab (Campath-1H), or other immunosuppressive T cell-targeted monoclonal antibodies ≤ 28 days before randomization.
    3. Evidence of active Grade >2 acute GVHD.
    4. Uncontrolled or progressive bacterial or fungal infections.
    5. Uncontrolled or progressive viral infections not targeted by PSL.
    6. Uncontrolled or progressive EBV-associated post-transplant lymphoproliferative disorder.
    7. Known or presumed pneumonia secondary to any organism.
    8. Donor lymphocyte infusion performed ≤ 21 days before randomization.
    9. Hemodynamic or respiratory instability.
    10. Hemoglobin <7 g/dL despite red blood cell transfusions.
    11. Clinically significant coagulopathy.
    12. Ongoing use of systemic anticoagulant drugs or antiplatelet drugs.
    13. Evidence of active hepatic sinusoidal obstruction syndrome.
    14. Liver dysfunction.
    15. Requiring renal replacement therapy ≤7 days prior to randomization.
    16. Evidence of encephalopathy.
    17. Relapse of primary malignancy.
    18. Receipt of other investigational antiviral treatments (eg, brincidofovir) within 7 days prior to randomization.
    19. Pregnant, lactating, planning to become pregnant.
    20. History of severe allergy to any component of PSL.
    21. Any condition that would compromise the safety of the participant.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the time to resolution of macroscopic hematuria in participants with documented BK viruria.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Until the participant reaches the primary endpoint, the assessments will be performed daily up to Week 12. After Week 12, the assessments will be performed twice per week until Week 24.
    E.5.2Secondary end point(s)
    1) Time to resolution of bladder pain as measured by age-appropriate COAs.
    2) Number of days in the hospital.
    3) Time to resolution of viremia for all target viruses.
    4) Average daily bladder pain.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For the 1st secondary end point – the assessments will be performed daily up to Week 12. After Week 12, the assessments will be performed weekly until Week 24.
    For 2nd and 3rd secondary end points - Week 24.
    For 4th secondary end point - Week 6.
    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.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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    Canada
    Korea, Republic of
    United States
    France
    Sweden
    Spain
    Italy
    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
    Last visit last subject (LVLS) or when the Sponsor receives the last laboratory result, whichever comes last.
    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 months10
    E.8.9.1In the Member State concerned days18
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days18
    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: 35
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 4
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 11
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 72
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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
    Pediatric patients
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 125
    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)
    None.
    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 IMPACT Partnership
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-11-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 20 04:21:00 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA