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    Summary
    EudraCT Number:2013-000903-18
    Sponsor's Protocol Code Number:0113-CL-1004
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-06-26
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2013-000903-18
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Protective Efficacy and Safety of a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)
    Estudio de fase 3 aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia protectora y la seguridad de una vacuna terapéutica, ASP0113, en receptores seropositivos para el citomegalovirus (CMV) sometidos a alotrasplante de células hematopoyéticas (ATCH)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study (Phase III) to assess the Evaluate the Protective Efficacy and Safety of a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT), when compared against placebo in a randomised, double blind manner.
    Estudio de fase 3 aleatorizado, para evaluar la eficacia protectora y la seguridad de una vacuna terapéutica, ASP0113, en receptores seropositivos para el citomegalovirus (CMV) sometidos a alotrasplante de células hematopoyéticas (ATCH) cuando se compara con el placebo en un estudio aleatorizado, doble ciego.
    A.4.1Sponsor's protocol code number0113-CL-1004
    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 SponsorAstellas Pharma Global Development, Inc. (APGD)
    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 supportAstellas Pharma Global Development, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstellas Pharma Global Development, Inc.
    B.5.2Functional name of contact pointMichelle Durgin
    B.5.3 Address:
    B.5.3.1Street Address1 Astellas Way
    B.5.3.2Town/ cityNorthbrook, IL
    B.5.3.3Post code60062
    B.5.3.4CountryUnited States
    B.5.4Telephone number+12242058943
    B.5.5Fax number+12242055763
    B.5.6E-mailmichelle.durgin.contractor@astellas.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 / (3/12/1042)
    D.3 Description of the IMP
    D.3.1Product nameASP0113
    D.3.2Product code ASP0113
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot available
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeASP0113, VCL-CB01, bivalent vaccine, TransVax
    D.3.9.3Other descriptive nameCovalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes.
    D.3.9.4EV Substance CodeSUB88620
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) Yes
    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 placeboSuspension for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    CMV reactivation after allogeneic stem cell transplantation.
    E.1.1.1Medical condition in easily understood language
    CMV infection, disease, and related complications occuring in people who's immune system has been affected by a bone marrow transplant for leukaemia, MDS or lymphoma.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10049107
    E.1.2Term CMV viraemia
    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
    Part 1
    -To assess the adequacy of the primary endpoint, overall mortality, through one year post-transplant to evaluate the vaccine efficacy of ASP0113 in HCT recipients, and, if necessary, select additional components for an alternative primary composite endpoint.
    -To evaluate the safety of ASP0113 in subjects undergoing allogeneic HCT
    Part 2
    -To evaluate the vaccine efficacy of ASP0113 compared with placebo as measured by overall mortality or an alternative primary composite endpoint selected based on Part 1 results, through one year post-transplant.
    -To evaluate the safety of ASP0113 in subjects undergoing allogeneic HCT.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenomics Sub-Study, 27 March 2013
    The pharmacogenomic research that will be conducted in the future with acquired saliva
    samples is exploratory. The objective of this research is to comprehensively analyze:
    -Suspected disease-related genes.
    -Genes of relevance to clinical response, pharmacokinetics, and toxicity/safety issues,
    to be identified in a pecautionary/retrospective setting.

    Donor Sub-Study, 27 March 2013
    If a subject has consented and is participating in the optional donor cell sub-study, a 1 mL sample of the donor cell product will be obtained to test for CMV-specific T-cells on the day of transplant (donor cell infusion).

    Abbott Molecular Sub-Study, 18 March 2013
    Abbott RealTime CMV is marketed in Europe and other parts of the world for use in deciding to begin anti-viral treatment along with other symptoms and tests that may be present. It is also used to check how a patient is responding to anti-viral treatment.
    The objectives of this protocol are:
    -To provide viral load results for plasma specimens collected from HCT recipients enrolled in Astellas protocol 0113-CL-1004 for routine surveillance of viremia.
    -To evaluate the investigational Abbott RealTime CMV assay with plasma and whole blood specimens collected from HCT recipients.
    The results of this study may be included in one or more premarket submissions to
    regulatory agencies including the US FDA.
    E.3Principal inclusion criteria
    1. Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent and privacy language as per national regulations (e.g., HIPAA Authorization for U.S. sites) must be obtained from the subject or legally authorized representative prior to any study-specific related procedures (including withdrawal of prohibited medication, if applicable).
    2. Subject is a male or female subject who is at least 18 years old or the legal age of consent (whichever is greater).
    3. Subject is a CMV-seropositive HCT recipient as confirmed by local laboratory at Screening.
    4. Subject is planned to undergo either of the following:
    a. Sibling Donor Transplant - 7/8 HLA-A, -B, -C, -DRß1 match utilizing high resolution typing or 8/8 HLA-A, -B, -C, -DRß1 match utilizing low or high resolution typing.
    b. Unrelated Donor Transplant - 7/8 or 8/8 HLA-A, -B, -C, -DRß1 match utilizing high resolution typing.
    5. Subject is scheduled to receive an allogeneic peripheral blood stem cell (PBSC) or bone marrow transplant (BMT) for the treatment of hematologic disorders as indicated in Inclusion Criterion 6.
    6. Subject has one of the following underlying diseases
    a. Acute myeloid leukemia (AML), with or without a history of myelodysplastic syndrome, in first or second complete remission or in early relapse (< 20% blasts in bone marrow with no circulating blasts in peripheral blood and no extramedullary leukemia).
    b. Acute lymphoblastic leukemia (ALL), in first or second complete remission.
    c. Acute undifferentiated leukemia (AUL) in first or second complete remission.
    d. Acute biphenotypic leukemia in first or second complete remission.
    e. Chronic myelogenous leukemia (CML) in either chronic or accelerated phase.
    f. Chronic lymphocytic leukemia (CLL).
    g. One of the following myelodysplastic syndrome(s) (MDS) defined by the following:
    i. Refractory anemia.
    ii. Refractory anemia with ringed sideroblasts.
    iii. Refractory cytopenia with multilineage dysplasia.
    iv. Refractory cytopenia with multilineage dysplasia and ringed sideroblasts.
    v. Refractory anemia with excess blasts-1 (5-10% blasts).
    vi. Refractory anemia with excess blasts-2 (10-20% blasts).
    vii. Myelodysplastic syndrome (MDS), unclassified.
    viii. MDS associated with isolated del (5q).
    ix. Chronic myelomonocytic leukemia (CMML).
    h. Primary or secondary myelofibrosis without leukemic transformation except if Dynamic
    International Prognostic Scoring System (DIPSS) category of high or intermediate-2.
    i. Lymphoma (including Hodgkin?s) with chemosensitive disease (> 50% response to
    chemotherapy).
    E.4Principal exclusion criteria
    1. Subject has active CMV disease or infection or has received treatment for active CMV disease or infection within 3 months (90 days) prior to transplant.
    2. Subject has planned CMV prophylactic therapy with antiviral drugs or CMV-specific immunoglobulins from Randomization through the Primary Study Period Completion/Day 365 Visit (Visit 14).
    3. Subject has a modified hematopoietic cell transplant comorbidity index (HCT-CI) score > 3.
    4. Subject is known to be positive for human immunodeficiency virus (HIV), hepatitis B surface antigen or hepatitis C RNA.
    5. Donor CMV serostatus is unknown.
    6. Subject has received any of the following substances or treatments:
    a. Alemtuzumab within 60 days prior to transplant, including conditioning regimen. Subjects for whom treatment with alemtuzumab is planned at any time from 60 days prior to through one year post-transplant should not be enrolled in the trial.
    b. T cell depletion of donor cell product.
    c. Administration of a CMV vaccine, including any prior exposure to ASP0113.
    7. Subject has received an allogeneic stem cell transplant within one year prior to transplant
    (subjects who have received a prior autologous transplant are allowed).
    8. Subject has a current malignancy in addition to the malignancy being treated for the study
    or the subject has a history of any other malignancy (within the past 5 years prior to Screening) except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully or cancer in situ of the cervix uteri that has been handled by local surgery.
    E.5 End points
    E.5.1Primary end point(s)
    The primary variable for Part 1 is overall mortality through one year post-transplant. For Part 2, the primary endpoint may be the same or may be changed to a composite endpoint with additional components from the following CMV EOD, aGVHD, cGVHD, and serious bacterial, viral, or fungal infections selected based on the results of Part 1 and a pre-specified algorithm.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Through one year post-transplant.
    E.5.2Secondary end point(s)
    -Time to first protocol-defined CMV viremia load [CMV plasma viral > 1560 IU/mL (1000 copies/mL by the Abbott RealTime CMV assay) as assessed by the central laboratory] through one year post-transplant.
    -Time to first adjudicated CMV-specific AVT through one year post ?transplant.
    -Time to first CMV-specific AVT for protocol-defined CMV viremia [CMV plasma viral load > 1560 IU/mL (1000 copies/mL by the Abbott RealTime CMV assay) as assessed by the central laboratory] or CMV EOD through one year post-transplant.
    -Incidence of severe treatment-emergent infections other than CMV through one year post-transplant.
    -Time to severe treatment-emergent infections other than CMV through one year post-transplant.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Through one year post-transplant.
    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 Yes
    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 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 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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    Belgium
    Canada
    France
    Germany
    Japan
    Korea, Democratic People's Republic of
    Spain
    Sweden
    Taiwan
    United States
    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
    For regulatory reporting purposes, the end of the trial will be the last visit of the last subject during the primary study period (day 365/Visit 14). An addendum to the clinical study report will be prepared after completion of the long-term follow up period (5.5 years post transplant).
    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 months9
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months9
    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 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: 450
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state72
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 210
    F.4.2.2In the whole clinical trial 500
    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)
    Subjects will be contacted by telephone annually after the last injection of vaccine through 5.5 years posttransplant for long-term safety related to the DNA vaccine. Items to be assessed by questionnaire and/or via retrospective chart review, to include; mortality, development of any new/recurrent cancer, development of infection requiring hospitalization or resulting in death, and erythema and induration at the injection site.
    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 Decision2013-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-03-01
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    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
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