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    Summary
    EudraCT Number:2011-000033-36
    Sponsor's Protocol Code Number:LYMRIT-37-01
    National Competent Authority:Czech Republic - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-08-05
    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 ConcernedCzech Republic - SUKL
    A.2EudraCT number2011-000033-36
    A.3Full title of the trial
    A phase I/II study of lutetium (177Lu)-lilotomab satetraxetan (Betalutin®) antibody-radionuclide-conjugate for treatment of relapsed non-Hodgkin lymphoma
    Studie protilátky radionuklidového konjugátu lutecium (177Lu) lilotomab satetraxetanu (Betalutin®) fáze I/II při léčbě recidivujícího non-Hodgkinova lymfomu
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of lymphoma with targeted internal radiation therapy
    (Betalutin)
    A.4.1Sponsor's protocol code numberLYMRIT-37-01
    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 SponsorNordic Nanovector ASA
    B.1.3.4CountryNorway
    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 supportKreftforeningen
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportSkattefunn
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportInnovation Norway
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNordic Nanovector ASA
    B.5.2Functional name of contact pointHead of Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressKjelsåsveien 168B
    B.5.3.2Town/ cityOslo
    B.5.3.3Post codeNO-0884
    B.5.3.4CountryNorway
    B.5.4Telephone number+4722183301
    B.5.5Fax number+4722580007
    B.5.6E-mailimlindvig@nordicnanovector.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/03/14/1271
    D.3 Description of the IMP
    D.3.1Product nameBetalutin
    D.3.2Product code Lutetium (177Lu)-lilotomab satetraxetan
    D.3.4Pharmaceutical form Solution for injection
    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 INNLutetium (177Lu)-lilotomab satetraxetan
    D.3.9.1CAS number 1453362-90-7
    D.3.9.2Current sponsor code177Lu-DOTA-HH1
    D.3.9.3Other descriptive name177LU-TETRAXETAN-TETULOMAB
    D.3.9.4EV Substance CodeSUB121341
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number395
    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) 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 Yes
    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.IMP: 2
    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 nameLilotomab
    D.3.2Product code HH1
    D.3.4Pharmaceutical form Concentrate for solution 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 INNLilotomab
    D.3.9.1CAS number 1453362-55-4
    D.3.9.2Current sponsor codeHH1
    D.3.9.3Other descriptive nameTETULOMAB
    D.3.9.4EV Substance CodeSUB121342
    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) 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.IMP: 3
    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 MabThera
    D.2.1.1.2Name of the Marketing Authorisation holderRoche
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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/3/14/1271 in follicular lymphoma
    D.3 Description of the IMP
    D.3.1Product nameMabThera
    D.3.4Pharmaceutical form Concentrate for solution 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 INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.2Current sponsor codenot applicable
    D.3.9.3Other descriptive namenot applicable
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) 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) 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
    Non-Hodgkin B-cell lymphoma
    Part A: Relapsed indolent Non-Hodgkin B-cell lymphoma Part B: Relapsed follicular lymphoma
    E.1.1.1Medical condition in easily understood language
    Lymph cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10029547
    E.1.2Term Non-Hodgkin's lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part A:
    Phase I:
    To define MTD of Betalutin
    Phase IIa: To explore tumour response rates in patients receiving Betalutin

    Part B:
    To evaluate the efficacy of the "40/15" dose regimen (40 mg lilotomab / 15 MBq/kg Betalutin) compared with "100/20" dose regimen (100 mg/m2 lilotomab/ 20 MBq/kg Betalutin) based on an Independent Review Committee (IRC) assessment of tumour response rates in adult patients with relapsed rituximab/anti-CD20-refractory follicular lymphoma.
    E.2.2Secondary objectives of the trial
    Part A:
    Phase I: To establish recommended dose of Betalutin for phase IIa, investigate safety, toxicity, biodistribution, pharmacokinetics and to explore the efficacy.
    Phase IIa: to confirm the recommended dose of Betalutin from Part A, phase I, investigate safety and toxicity, estimate progression free survival and overall survival, quality of life.

    Part B:
    To compare the treatment groups in terms of safety, progression free survival, overall survival and duration of response as well as exploratory pharmacokinetics and quality of life measurements.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Part A:
    1. Histologically confirmed (by WHO classification) relapsed incurable non-Hodgkin B-cell lymphoma of following subtypes; follicular grade I-IIIA, marginal zone, small lymphocytic, lymphoplasmacytic, mantle cell.
    For the arm 4, phase 2 expansion cohort patients who are refractory to prior therapy (defined as a lack of response or disease progression within 6 months of completion of therapy) will also be eligible for inclusion.
    2. Age ≥ 18 years.
    3. A pre-study WHO performance status of 0-1.
    4. Life expectancy should be ≥ 3 months.
    5. <25% tumour cells in bone marrow biopsy (biopsy taken from a site not previously irradiated).
    6. Measurable disease by radiological methods.
    7. Women of childbearing potential must:
    a) understand that the study medication is expected to have teratogenic risk.
    b) have a negative pregnancy test.
    c) agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout study drug therapy and for 12 months after end of study drug therapy, even if she has amenorrhoea.
    8. Male subjects must agree to use condoms during intercourse throughout study drug therapy and the following 12 months.
    9. Patients previously treated with native rituximab are eligible.
    10. The patient is willing and able to comply with the protocol, and agrees to return to the hospital for follow-up visits and examination.
    11. The patient has been fully informed about the study and has signed the informed consent form.
    Part B:
    1. Histologically confirmed (by WHO classification) relapsed non- Hodgkin B-cell FL (follicular grade I-IIIA).
    2. Male or female aged ≥ 18 years.
    3. Received at least 2 prior chemotherapy- or immunotherapy-based regimens.
    4. Prior therapy must include rituximab/anti-CD20 agent and an alkylating agent. Prior exposure to idelalisib or other phosphatidylinositol 3-kinase (PI3K) inhibitors is also allowed.
    5. Patients must be refractory to the last rituximab/anti-CD20 based treatment, defined as
    - no response (no CR/PR) during therapy
    - or a response (CR/PR) lasting less than 6 months after the completion of a regimen of rituximab/anti-CD20 therapy (including occurrence of progressive disease (PD) during rituximab/anti-CD20 maintenance therapy, or within 6 months of completion of maintenance therapy).
    6. A previous regimen is defined as one of the following: at least 2 months of single-agent therapy; at least 2 consecutive cycles of chemotherapy.
    7. WHO performance status of 0-2.
    8. Life expectancy of ≥ 3 months.
    9. Bone marrow tumour infiltration < 25% (in biopsy taken from a site not previously irradiated).
    10. Measurable disease by CT: longest diameter (LDi) > 1.5 cm for nodal lesion, LDi > 1.0 cm for extra nodal lesion within 28 days prior to start of treatment.
    11. ANC ≥ 1.5 x 109/L.
    12. Platelet count ≥ 150 x 109/L .
    13. Haemoglobin ≥ 9.0 g/dL.
    14. Total bilirubin ≤1.5 x upper limit of normal (ULN) (except patients with documented Gilbert's syndrome [< 3.0 mg/dL]).
    15. Liver enzymes: Aspartate transaminase (AST); Alanine transaminase (ALT) or ALP ≤ 2.5 x ULN (or ≤ 5.0 x ULN with liver involvement by primary disease).
    16. Adequate renal function as demonstrated by a serum creatinine <
    1.5 x ULN.
    17. Women of childbearing potential must:
    a) understand that the study medication is expected to have teratogenic risk.
    b) have a negative serum beta human-chorionic gonadotropin (ß-HCG) pregnancy test at screening and before Betalutin injection.
    c) commit to continued abstinence from heterosexual intercourse (excluding periodic
    abstinence or the withdrawal method) or begin 2 acceptable methods of birth control with a Pearl-Index ≤ 1%, without interruption from 4 weeks before starting study medication, throughout study medication therapy and for 12 months after end of study medication therapy, even if she has amenorrhoea. Apart from abstinence, acceptable methods of birth control are:
    i. Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal).
    ii. Progestogen-only hormonal contraception associated with inhibition of ovulation ((oral, injectable, implantable)
    iii. Intrauterine device (IUD).
    iv. Intrauterine hormone-releasing system (IUS).
    v. Bilateral tubal occlusion.
    vi. Vasectomised partner.
    18. Male patients must agree to use condoms during intercourse throughout study medication therapy and the following 12 months.
    19. The patient is willing and able to comply with the protocol, and agrees to return to the hospital for follow-up visits and examination.
    20. The patient has been fully informed about the study and has signed the informed consent form.
    21. Negative HAMA test at screening.
    22. Negative Hepatitis B (negative HBsAG and anti-HBC), Hepatitis C and HIV test at screening
    E.4Principal exclusion criteria
    Part A:
    1. Medical contraindications, including uncontrolled infection, severe cardiac, pulmonary, neurologic, psychiatric or metabolic disease, uncontrolled asthma/allergy requiring systemic steroids, known HIV positive.
    2. Laboratory values within 15 days pre-registration:
    a. Absolute Neutrophil Counts (ANC) ≤ 1.5 x 109 /l.
    b. Platelet count ≤ 150 x 109 /l.
    *Patients with a screening platelet count of 100-150 x 109/l may be considered for enrolment in phase II arm 4 following review of safety data by the Safety Review Committee for the patients with a screening platelet count >150 x 109/l treated with 20 MBq/kg Betalutin and 100
    mg/m2 lilotomab. The dose of Betalutin administered to patients with a platelet count of 100-150 x 109/l is described in section 6.2.
    c. Total bilirubin ≥ 30 mmol/l.
    d. ALP and ALAT ≥ 4x normal level.
    e. Creatinine ≥ 115 µmol/l (men), 97 µmol/l (women).
    3. Known CNS involvement of lymphoma.
    4. Previous total body irradiation.
    5. Known history of HAMA.
    6. Chemotherapy or immunotherapy received within the last 4 weeks prior to start of study treatment. Pre-treatment with rituximab is allowed.
    7. Pregnant or lactating women.
    8. Previous hematopoietic stem cell transplantation (autologous and allogenic).
    9. Previous treatment with radioimmunotherapy.
    10. Actively participating in another study or received an investigational drug within 4 weeks prior to enrolment.
    11. Receipt of live, attenuated vaccine within 30 days prior to enrolment.
    12. Test positive for hepatitis B (HBsAg and anti-HBc).
    13. A known hypersensitivity to rituximab, lilotomab, Betalutin or murine proteins or any excipient used in rituximab, lilotomab or Betalutin.

    Part B:
    1. Prior hematopoietic allogenic stem cell transplantation.
    2. Prior autologous stem cell transplantation.
    3. Evidence of histological transformation from FL to diffuse large B-cell lymphoma (DLBCL) at time of screening.
    4. Previous total body irradiation.
    5. Prior anti-lymphoma therapy (chemotherapy, immunotherapy or other investigational agent) within 4 weeks prior to start of study treatment (corticosteroid treatment at doses of ≤ 20 mg/day, topical or inhaled corticosteroids, granulocyte colony-stimulating factor [G-CSF] or granulocytemacrophage colony-stimulating factor [GM-CSF] are permitted up to 2 weeks prior to start of study treatment). Note: excludes pre-treatment with rituximab as part of this study.
    6. Patients who are receiving any other investigational medicinal products.
    7. Patients with known or suspected CNS involvement of lymphoma.
    8. History of a previous treated cancer except for the following:
    a. adequately treated local basal cell or squamous cell carcinoma of the skin.
    b. cervical carcinoma in situ.
    c. superficial bladder cancer.
    d. localised prostate cancer undergoing surveillance or surgery.
    e. localised breast cancer treated with surgery and radiotherapy but not including systemic chemotherapy.
    f. other adequately treated Stage 1 or 2 cancer currently in CR.
    9. Pregnant or breastfeeding women.
    10. Exposure to another CD37 targeting drug.
    11. Allergy to X-ray contrast agents.
    12. A known hypersensitivity to rituximab, lilotomab, Betalutin or murine proteins or any excipient used in rituximab, lilotomab, or Betalutin.
    13. Has received a live-attenuated vaccine within 30 days prior to enrolment.
    14. Evidence of severe or uncontrolled systemic diseases:
    a. Uncontrolled infection including evidence of ongoing systemic bacterial, fungal, or viral infection (excluding viral upper respiratory tract infections) at the time of initiation of study treatment.
    b. Pulmonary conditions e.g. unstable or uncompensated respiratory disease.
    c. Hepatic, renal, neurological, or metabolic conditions - which in the opinion of the investigator would compromise the protocol objectives.
    d. Psychiatric conditions e.g. patients unlikely to comply with the protocol, e.g. mental condition rendering the patient unable to understand the nature, scope, and possible consequences of participating in the study.
    e. History of erythema multiforme, toxic epidermal necrolysis, or Stevens-Johnson syndrome.
    f. Cardiac conditions, including
    i. history of acute coronary syndromes (including unstable angina).
    ii. class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
    iii. known uncontrolled arrhythmias (except sinus arrhythmia) in the past 24 weeks.
    E.5 End points
    E.5.1Primary end point(s)
    Part A:
    • Incidence and severity of adverse events and serious adverse events graded according to the National Cancer Institute – Common Terminology Criteria for Adverse Events (CTCAE version 4).
    • Changes from baseline in laboratory variables: haematology and serum biochemistry.
    • Changes from baseline in body temperature and vital signs (systolic/diastolic blood pressure and heart rate) during the treatment period.
    • Changes from baseline in physical examination during the treatment period.
    Part B:
    • Overall response rate (ORR) defined as the proportion of patients who achieve a confirmed CR or PR based on Cheson criteria (version 2014).
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline and up to 12 weeks post injection
    E.5.2Secondary end point(s)
    Part A:
    • Incidence of potential late toxicity, such as new primary cancers and bone marrow changes (acute myelogenous leukaemia, myelodysplastic syndrome, and aplastic anaemia).
    • Overall survival.
    • Estimation of whole-body retention of radioactivity at each imaging time post-injection.
    • Estimation of the individual organ uptake/retention of radioactivity at each imaging time-point after injection.
    • Estimate retention of administered radioactivity in blood.
    • Calculation of estimated absorbed radiation dose to target organs.
    • Tumour response rate.
    • Tumour response duration.
    • Progression-free survival
    • Performance status defined as improvement or worsening, respectively, by 1-point or more on the ECOG scale from the baseline value
    • Quality of life (QoL) assessed using Functional Assessment of Cancer Therapy–Lymphoma (FACT-Lym) questionnaire
    Part B:
    • Incidence and severity of AEs
    • DoR – defined as the interval from the first documentation of CR or PR to the first documentation of disease progression or death from any cause, whichever comes first.
    • PFS – defined as the interval from the start of Betalutin treatment to the first documentation of disease progression.
    • OS - defined as the interval from the start of Betalutin treatment to death from any cause, including disease progression.
    • Change from baseline in the sum of the product of the greatest perpendicular diameters (SPD) of target lymph nodes as documented
    radiographically.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline and up to 5 years post injection
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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
    15 MBq/kg Betalutin after 40 mg lilotomab versus 20 MBq/kg Betalutin after 100mg/m2 lilotomab
    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 EEA60
    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
    European Union
    Israel
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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: 66
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 134
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 144
    F.4.2.2In the whole clinical trial 200
    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)
    The patient will follow routinely control as requested by treating physician
    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 Decision2015-04-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-19
    P. End of Trial
    P.End of Trial StatusOngoing
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