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    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7294   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:2017-004443-20
    Sponsor's Protocol Code Number:HP-LY-CL-2063
    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:2018-07-19
    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 ConcernedSweden - MPA
    A.2EudraCT number2017-004443-20
    A.3Full title of the trial
    A Phase II, double-blind, placebo-controlled, randomized study to assess the efficacy, safety and tolerability of Lymfactin® (AdAptVEGF-C Adenoviral Vector) in combination with a surgical lymph node transfer for the treatment of patients with secondary lymphedema associated with the treatment of breast cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II, placebo-controlled study of the efficacy, safety and tolerability of Lymfactin® in combination with a surgical lymph node transfer for the treatment of patients with secondary lymphedema associated with the treatment of breast cancer
    En Fas II, placebokontrollerad, effekt, säkerhets- och tolerabilitetsstudie med Lymfactin i kombination med ett kirurgiskt lymfnodstransplantat för behandling av patienter med sekundärt lymfödem associerat med behandling av bröstcancer
    A.3.2Name or abbreviated title of the trial where available
    AdeLE
    A.4.1Sponsor's protocol code numberHP-LY-CL-2063
    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 SponsorHerantis Pharma Plc
    B.1.3.4CountryFinland
    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 supportHerantis Pharma Plc
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHerantis Pharma Plc
    B.5.2Functional name of contact pointSponsor Study Contact
    B.5.3 Address:
    B.5.3.1Street AddressBertel Jungin Aukio 1
    B.5.3.2Town/ cityEspoo
    B.5.3.3Post code02600
    B.5.3.4CountryFinland
    B.5.4Telephone number00358449731940
    B.5.6E-mailsatu.leikas@herantis.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLymfactin
    D.3.2Product code LX-1101
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOther use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot known
    D.3.9.2Current sponsor codeLX-1101
    D.3.9.3Other descriptive nameAdAptVEGF-C adenoviral vector
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number95000000000
    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 No
    D.3.11.3.2Gene therapy medical product Yes
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberGene Therapy Medicinal Product (Ref EMA/CAT/758151/2009)
    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 Yes
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboOther use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Secondary lymphedema associated with the treatment of breast cancer
    E.1.1.1Medical condition in easily understood language
    Swelling caused by a build-up of lymph fluid in the surface tissues of the body associated with the treatment of breast cancer
    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 10036389
    E.1.2Term Postmastectomy lymphedema syndrome
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10025233
    E.1.2Term Lymphedema
    E.1.2System Organ Class 100000004866
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10006187
    E.1.2Term Breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of Lymfactin® in patients with secondary lymphedema associated with the treatment of breast cancer by comparing the effects of active study treatment Lymfactin® to placebo. Efficacy of Lymfactin® will be evaluated by the change in the volume of the affected arm, quantitative lymphoscintigraphy and patient quality of life assessment.
    E.2.2Secondary objectives of the trial
    Secondary Study Objectives
    To assess the safety and tolerability of Lymfactin® by comparing the effects of active study treatment to placebo, to investigate the biodistribution of Lymfactin® in blood and in wound secretion, the development of anti-Lymfactin® antibodies, the VEGF-C concentration in wound secretion and the systemic VEGF-C concentration after Lymfactin® administration.
    Exploratory Study Objectives
    To evaluate two new methods in the assessment of lymphedema: MRI lymphangiography, and PWC measurement for water content and edema in tissue (MoistureMeterD Compact, Delfin Technologies).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female or male patients with secondary lymphedema associated with the treatment of breast cancer and
    a) Has undergone sentinel lymph node biopsies and/or lymph node resection in the axilla on the affected side of their breast cancer with initial N1-N2a staging and lymph node metastasis in ≤ 9 axillary lymph nodes.
    b) Requires garment use as a compression treatment for the lymphedema in the affected arm.
    c) Has the volume of the affected arm at least 10% greater than the unaffected arm following 7 days without compression garment.
    d) Has the presence of pitting edema in the affected arm without compression garment.
    e) Has had lymphedema for less than 5 years.
    2. No evidence of recurrent or active breast cancer for at least 2 years after the breast cancer surgery and/or the end of chemotherapy and/or radiotherapy (excluding endocrine treatment).
    3. Patient understands and voluntarily signs the written informed consent prior to any screening procedure.
    4. 18-70 years of age at time of the informed consent.
    5. ECOG Performance Status of 0 or 1.
    6. BMI between 18 and 32 inclusive.
    7. PET CT scan of the chest and the abdomen within 28 days before the study treatment without signs of active breast cancer or any other malignancy.
    8. Adequate hematologic and end-organ function:
    a) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x the institutional upper limit of normal (ULN)
    b) Bilirubin ≤ 1.5 x ULN (except in patients with previously documented Gilbert’s syndrome, in which case total bilirubin ≤ 3 x ULN)
    c) INR and aPTT ≤ 1.5 x ULN (for patients requiring therapeutic anticoagulation therapy, a stable INR ≤ 2,5)
    d) Serum creatinine ≤ 1,5 x ULN or creatinine clearance ≥ 50 ml/min
    e) Absolute neutrophil count (ANC) ≥ 1,5 E9/l
    f) Platelet count ≥ 100 E9/l g) Hemoglobin ≥ 100 g/l
    9. Willingness to comply with scheduled visits, laboratory assessments, and other study-related procedures due to the regulatory requirements related to gene based therapies.
    10. Non-smoker or willing to stop smoking or use of nicotine-containing products for at least 4 weeks prior to the study entry.
    11. Negative urine pregnancy test (only patients with childbearing potential) at screening and use of adequate contraceptive measures from screening until six months after the study treatment administration:
    a) A patient with childbearing potential should be using a reliable contraception method: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal, progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device (IUD), intrauterine hormone releasing system (IUS), bilateral tubal occlusion, vasectomised partner or sexual abstinence defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments.
    b) A male patient is not allowed to donate sperm.
    c) A patient with no current heterosexual relationship may be included according to the judgement of the Investigator.
    d) For a patient in postmenopausal state neither contraception nor a pregnancy test is required. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy.
    e) For a permanently sterile patient neither contraception nor a pregnancy test is required. A permanently sterile is defined by history of hysterectomy, bilateral salpingectomy or bilateral oophorectomy.
    E.4Principal exclusion criteria
    1. Diagnosed for T4 and/or N2b/N3 stage breast cancer at
    the time of the original diagnosis.
    2. Evidence (clinical, laboratory or imaging) or history of
    a neoplasm other than breast cancer (except basal cell
    carcinoma or cervical in situ carcinoma).
    3. Diagnosed for metastatic breast cancer.
    4. Pregnancy, lactation or a positive or indeterminate
    pregnancy test.
    5. Current treatment with COX-2 inhibitors should be interrupted from 2 weeks prior until 4 weeks posttreatment.
    6. Previous treatment with, or participation in a trial of a gene therapy product.
    7. Participation in a clinical trial, which has included interventions in the preceding 6 months, or will involve future interventions. Participation in a non-interventional clinical trial, or in a non-interventional follow-up of any clinical trial, does not make the patient inappropriate for the entry into this study.
    8. Current treatment with systemic immunosuppressive drugs.
    9. Current history of drug abuse, including nicotine-containing products, or alcohol abuse.
    10. Known human immunodeficiency virus- or acquired immunodeficiency syndrome-related illness.
    11. History of hepatic dysfunction, cirrhosis, or hepatitis.
    12. Allergy to any ingredients of the Lymfactin® solution for injection (glycerol, N-2-hydroxyethylpiperazine-N´-2-ethanesulfonic acid (HEPES), sodium hydroxide).
    13. Other concurrent severe acute and/or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with the study participation or study drug administration, that would, in the Investigator’s judgement, affect the patient's ability to follow study-related procedures, or that may interfere with the interpretation of study results and would make the patient inappropriate for the entry into this study.
    14. Doubtful availability, in the opinion of the Investigator, to complete the study.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy is the primary endpoint of this study. The effects
    of the treatment on the signs and symptoms of lymphedema
    will be assessed by comparing the effects of the active
    study treatment Lymfactin® to placebo up to 24 months
    post-treatment by:
    • The measurement of the volumes of the affected arm
    and the unaffected arm.
    • Quantitative lymphoscintigraphy (99Tc-nanocolloid
    clearance rate) with calculation of transport index
    (change from baseline) up to 24 months
    • Patient quality of life assessment using the
    Lymphedema Quality of Life Inventory (LyQLI)
    filled out by the patients (change from baseline).
    E.5.1.1Timepoint(s) of evaluation of this end point
    as specified in the protocol
    E.5.2Secondary end point(s)
    Safety endpoints
    To assess the safety of Lymfactin® treatment by:
    • Incidence, type and severity of clinically significant adverse events (based on NCI CTCAE v4.0) up to 5 years post-treatment.
    • Incidence, type and severity of serious adverse events up to 5 years post-treatment.
    • Physical examination, vital signs (blood pressure, heart rate, weight), 12-lead electrocardiogram (ECG) and laboratory tests including clinical chemistry, hematology and urinalysis up to 24 months. Brief hematology and clinical chemistry up to 5 years post-treatment.
    • Annual MRI scan (chest and abdomen) with radiocontrast up to 5 years post-treatment with a brief medical history.
    • To evaluate the potential development of edema at the donor site/limb, volume measurements of both legs will be performed (change from baseline and comparison to the unaffected/contralateral limb) up to 12 months post-treatment.

    Pharmacological Endpoints
    • To assess the biodistribution (presence and titer) of Lymfactin® in blood up to 30 days and in wound secretion up to 5-7 days (until hospital discharge) through qPCR post-treatment.
    • To assess the presence and titer of anti-Lymfactin® antibodies in serum up to 12 months posttreatment.
    • To assess the concentration of VEGF-C in wound secretion up to 5-7 days (until hospital discharge)
    post-treatment.
    • To assess the systemic concentration of VEGF-C in serum up to 30 days post-treatment.
    Exploratory Study Endpoints
    • Newly developed MRI lymphangiography assessment and comparison of the correlation of the method to the already established lymphoscintigraphy in the assessment of lymphedema up to 24 months post-treatment.
    • PWC measurement of water content and edema in tissue by a sensitive, non-invasive device (MoistureMeterD Compact, Delfin Technologies) up to 24 months post-treatment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    as specified in the protocol
    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) 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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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 No
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days23
    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: 32
    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 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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    Separate from this study, the patients are included in their individual oncological follow-up programs with clinical and imaging examinations according to the national and local recommendations.
    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 Decision2018-10-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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