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    The EU Clinical Trials Register currently displays   43977   clinical trials with a EudraCT protocol, of which   7312   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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    EudraCT Number:2014-003233-26
    Sponsor's Protocol Code Number:CD-ON-CAT-8015-1053
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-11-05
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-003233-26
    A.3Full title of the trial
    A Pivotal Multicenter Trial of Moxetumomab Pasudotox in
    Relapsed/Refractory Hairy Cell Leukemia
    Studio pilota, multicentrico su moxetumomab pasudotox nella leucemia a cellule capellute recidivante /refrattaria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Trial of Investigational Agent (Moxetumomab Pasudotox) in Patients with Relapsed/ Refractory Hairy Cell Leukemia
    studio Clinico su un farmaco sperimentale (moxetumomab pasudotox) in pazienti con leucemia a cellule capellute recidivante/refrattaria
    A.3.2Name or abbreviated title of the trial where available
    Moxetumomab Pasudotox in Relapsed/ Refractory Hairy Cell Leukemia
    Moxetumomab Pasudotox in leucemia a cellule capellute recidivante/refrattaria
    A.4.1Sponsor's protocol code numberCD-ON-CAT-8015-1053
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01829711
    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 SponsorMEDIMMUNE, LLC
    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 supportMedImmune, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedImmune, LLC
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressNA
    B.5.3.2Town/ cityNA
    B.5.3.3Post codeNA
    B.5.3.4CountryUnited States
    B.5.4Telephone number000000
    B.5.5Fax number000000
    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/3/08/592
    D.3 Description of the IMP
    D.3.1Product nameMoxetumomab Pasudotox
    D.3.2Product code [CAT-8015]
    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 INNMoxetumomab Pasudotox
    D.3.9.1CAS number 1020748-57-5
    D.3.9.2Current sponsor codeCAT-8015
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 1
    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. cell therapy medicinal product Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 Yes
    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
    Hairy Cell Leukemia
    Leucemia a cellule capellute
    E.1.1.1Medical condition in easily understood language
    A specific type of cancer of the blood
    Un tipo specifico di tumore del sangue
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10019056
    E.1.2Term Hairy cell leukemia variant
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10019055
    E.1.2Term Hairy cell leukemia
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the rate of durable complete response (CR) in multiply relapsed HCL with moxetumomab pasudotox.
    determinare il tasso di risposta completa (CR) duratura in pazienti con HCL multi-recidivante trattati con moxetumomab pasudotox.
    E.2.2Secondary objectives of the trial
    Determine the overall response rate (ORR), progression-free survival
    (PFS), time to treatment failure (TTF), and duration of responses (CR
    and partial response [PR]).
    -Confirm the tolerability and safety of moxetumomab pasudotox in
    patients with HCL.
    -Evaluate immunogenicity and pharmacokinetics (PK) of moxetumomab pasudotox.
    determinazione del tasso di risposta complessivo (ORR, Overall Response Rate), la sopravvivenza libera da progressione (PFS, Progression-free Survival), il tempo all'insuccesso del trattamento (TTF, Time to Treatment Failure), la durata della risposta (CR e risposta parziale [PR, Partial Response]), la conferma di sicurezza e tollerabilit¿ e la valutazione dell'immunogenicit¿ e della farmacocinetica di moxetumomab pasudotox.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must have histologically confirmed hairy cell leukemia or hairy
    cell leukemia variant .with a need for therapy based on at least one of
    the following criteria:
    neutrophils less than 1000/mm(3)
    platelets less than 100,000/mm(3)
    hemoglobin less than 10 g/dL)
    symptomatic splenomegaly.
    Patients must be Pseudomonas-immunotoxin naive
    Patients must have had at least 2 prior purine analogs, or at least 1
    course of purine analog and 1 of either rituximub or BRAF inhibitor.
    Men or women age greater than or equal to 18 years. Because this
    disease does not generally occur in children, children are excluded from
    this study, but will be eligible for future pediatric trials in other indications.
    ECOG performance status less than or equal to 2.
    The effects of moxetumomab pasudotox on the developing human fetus
    are unknown. For this reason, women of child-bearing potential and men
    must agree to use adequate contraception (hormonal or barrier method
    of birth control; abstinence) prior to study entry and for the duration of
    study participation, and 4 months after completion of moxetumomab
    pasudotox administration. Should a woman become pregnant or suspect
    she is pregnant while she or her partner is participating in this study,
    she should inform her treating physician immediately.
    Patients must have adequate organ function as defined below:
    total bilirubin less than or equal to 1.5 mg/dL, unless consistent with
    Gilbert s (ratio between total and direct bilirubin greater than 5)
    AST and ALT less than or equal to 3 times upper limit of normal (ULN)
    alkaline phosphatase less than or equal to 2.5 ULN
    serum creatinine less than or equal to 1.5 mg/dL or creatinine clearance
    greater than or equal to 60 mL/min as estimated by the Cockcroft-Gault
    Prothrombin time/INR or partial thromboplastin time less 2.5 ULN,
    fibrinogen greater than or equal to 0.5 LLN; if on warfarin, INR less than
    3.5, if on any other anticoagulation, PT less than 2.5 times baseline
    Ability to understand and the willingness to sign a written informed
    consent document.
    Life expectancy greater than or equal to 6 months
    1. I pazienti devono presentare leucemia a cellule capellute o una variante della leucemia a cellule capellute, con conferma istologica, e necessitare di una terapia sulla base di almeno uno fra i seguenti criteri:
    a. neutrofili < 1,0 x 109/l
    b. piastrine < 100 x 109/l
    c. emoglobina < 10 g/dl
    d. splenomegalia sintomatica
    2. I pazienti devono essere naïve all'immunotossina di Pseudomonas
    3. I pazienti devono aver ricevuto almeno 2 terapie sistemiche precedenti, compresi 2 cicli di un PNA, oppure 1 ciclo di rituximab o inibitore BRAF dopo un singolo ciclo di PNA.
    4. Uomini o donne di età > 18 anni. Poiché solitamente questa malattia non si manifesta nei bambini, questi sono esclusi dallo studio.
    5. Stato di prestazione Eastern Cooperative Oncology Group (ECOG) = 2 (vedere Appendice 2).
    6. I pazienti devono presentare una funzionalità adeguata degli organi, come definito di seguito:
    a. bilirubina totale = 1,5 mg/dl, a meno che non sia coerente con un quadro di sindrome di Gilbert (rapporto fra bilirubina totale e diretta > 5)
    b. AST e ALT = 3 volte il limite superiore dell'intervallo di normalità (ULN)
    c. fosfatasi alcalina < 2,5 ULN
    d. creatinina nel siero = 1,5 mg/dl o clearance della creatinina = 60 ml/min come stimato in base all'equazione di Cockcroft-Gault (Appendice 3)
    7. Tempo di protrombina (PT)/rapporto internazionale normalizzato (INR) o tempo di tromboplastina parziale (PTT) < 2,5 ULN, fibrinogeno = 0,5 del limite inferiore dell'intervallo di normalità; se il paziente assume warfarin, INR < 3,5, se utilizza qualsiasi altro anticoagulante, PT < 2,5 volte il valore basale
    8. Capacità di comprendere e volontà di firmare un documento scritto di consenso informato.
    9. Aspettativa di vita = 6 mesi.
    E.4Principal exclusion criteria
    Patients who have had chemotherapy, immunotherapy or radiotherapy
    within 4 weeks prior to initiation of treatment.
    Patients who are receiving any other investigational agents.
    Patients with known brain metastases should be excluded from this
    clinical trial because of their poor prognosis and because they often
    develop progressive neurologic dysfunction that would confound the
    evaluation of neurologic and other adverse events.
    Patients with clinically significant ophthalmologic findings during
    Pregnant or breastfeeding females. The effects of moxetumomab
    pasudotox on the developing fetus are unknown. Because there is an
    unknown but potential risk for adverse events in nursing infants
    secondary to treatment of the mother with moxetumomab pasudotox
    breastfeeding should be discontinued if the mother is treated with
    moxetumomab pasudotox
    Positive for Hepatitis B surface antigen unless the patient is on
    Lamivudine or Entecavir and Hepatitis B Viral DNA load is less than 2000

    Active second malignancy requiring treatment other than minor
    resection of indolent cancers like basal cell and squamous skin cancers
    Uncontrolled intercurrent illness including, but not limited to, ongoing or
    active infection, symptomatic congestive heart failure, unstable angina
    pectoris, cardiac arrhythmia, malaria infection or psychiatric
    illness/social situations that would limit compliance with study
    HIV-positive patients unless taking appropriate anti-HIV medications
    with a CD4 count of greater than 200. Otherwise, there may be increased
    risk of lethal infections when temporarily suppressing normal B-cells.
    History of allogeneic bone marrow transplant.
    Patients with history of both thromboembolism and known congenital
    hypercoagulable conditions.
    Uncontrolled pulmonary infection, pulmonary edema. Oxygen saturation at rest less than 88% measured by pulse oximetry or
    PaO (2) less than or equal to 55 mm Hg.
    Serum albumin less than 2 g/dL.
    Radioimmunotherapy within 2 years prior to enrollment in study.
    ANC less than 1000/mm(3), or platelet count less than 50,000/mm(3),
    if these cytopenias are not judged by the investigator to be due to
    underlying disease (ie, potentially reversible with antineoplastic
    therapy). A patient will not be excluded because of pancytopenia greater
    than or equal to Grade 3, or erythropoietin dependence, if it is due to
    disease, based on the results of bone marrow studies.
    Patients with less than 50% of predicted forced expiratory volume
    (FEV1) or less than 50% of predicted diffusing capacity for carbon
    monoxide (DLCO), corrected for hemoglobin concentration and alveolar
    volume. Note: Patients with no prior history of pulmonary illness are not
    required to have PFTs. FEV1 will be assessed after bronchodilator
    Patients with history of thrombotic microangiopathy or TTP-HUS.
    Patients with QTc elevation > grade 1
    Patient on high dose estrogen (defined as > 0.625 mg/day of an
    estrogen compound.
    Patients with clinical evidence of disseminated intravascular coagulation (grade 3-4)
    1. Pazienti che sono stati sottoposti a chemioterapia, immunoterapia o radioterapia nelle 4 settimane precedenti l'inizio del trattamento.
    2. Pazienti che assumono qualsiasi altro farmaco sperimentale.
    3. I pazienti con metastasi cerebrali note devono essere esclusi da questa sperimentazione clinica a causa della loro prognosi negativa e poiché spesso sviluppano una disfunzione neurologica progressiva, che può confondere la valutazione degli eventi avversi (AE, Adverse Event) neurologici e di altro tipo.
    4. Pazienti con distacco retinico o coroidale identificato durante la valutazione oftalmologica nella fase di screening.
    5. Donne in gravidanza o in allattamento (al seno). Non sono noti gli effetti di moxetumomab pasudotox sullo sviluppo del feto. Poiché esiste un rischio non noto ma potenziale di AE per i bambini in allattamento, associato al trattamento della madre con moxetumomab pasudotox, interrompere l'allattamento al seno se la madre viene trattata con moxetumomab pasudotox.
    6. Pazienti positivi all'anticorpo contro il core o l'antigene di superficie dell'epatite B, a meno che il paziente non assuma lamivudina o entecavir e la carica virale per il DNA del virus dell'epatite B non sia < 2000 UI/ml.

    8. Secondo tumore maligno attivo che richiede un trattamento diverso da una resezione di piccola entità di tumori indolenti, come i tumori cutanei a cellule basali e squamosi.
    9. Patologia intercorrente non controllata, comprese, a titolo esemplificativo, infezioni in corso o attive, insufficienza cardiaca congestizia sintomatica, angina pectoris instabile, ipertensione non controllata, aritmia cardiaca, infezione malarica o disturbo psichiatrico/condizioni sociali che limiterebbero la conformità ai requisiti dello studio.
    10. Pazienti con positività nota al virus dell'immunodeficienza umana (HIV), a meno che non assumano i farmaci anti-HIV appropriati e con un conteggio CD4 > 200. In caso contrario, esiste un maggiore rischio di contrarre infezioni letali se vengono temporaneamente soppresse le cellule B normali.
    11. Anamnesi di trapianto allogenico di midollo osseo.
    12. Pazienti con anamnesi di tromboembolia e condizioni congenite note di ipercoagulazione.
    13. Infezione polmonare non controllata, edema polmonare.
    14. Saturazione dell'ossigeno a riposo < 88% misurata con pulsossimetria
    o PaO2 = 55 mmHg
    15. Albumina nel siero < 2 g/dl
    16. Radioimmunoterapia nei 2 anni precedenti all'arruolamento nello studio.
    17. Conta assoluta dei neutrofili (ANC, Absolute Neutrophil Count) < 1,0 x 109/l o conta delle piastrine < 50 x 109/l, a meno che lo sperimentatore non la giudichi come associata a una malattia sottostante (ovvero potenzialmente reversibile con una terapia antineoplastica). Un paziente non verrà escluso in presenza di una pancitopenia di grado = 3 o di dipendenza da eritropoietina, se dovuta alla malattia, sulla base di risultati degli studi sul midollo osseo.
    18. Pazienti con < 50% del volume espiratorio forzato previsto (FEV1) o < 50% della capacità di diffusione prevista per il monossido di carbonio, corretta in base alla concentrazione di emoglobina a al volume alveolare (DLCO). Nota: per i pazienti senza anamnesi precedente di malattie polmonari non è necessario procedere al test della funzione polmonare (PFT). Il volume espiratorio forzato verrà valutato dopo la terapia broncodilatatoria.
    19. Pazienti con anamnesi di microangiopatia trombotica o microangiopatia trombotica/sindrome emolitica-uremica
    20. Pazienti con elevazione dell'intervallo QT corretta (Frederica) > 500 ms (sovralettura manuale da parte di personale medico qualificato) in base ad almeno due ECG a 12 derivazioni distinti.
    21. Pazienti che assumono estrogeni ad alte dosi (definite come > 0,625 mg/die di un composto estrogeno).
    22. Pazienti con evidenza clinica di coagulazione intravascolare disseminata (Grado 3-4).
    E.5 End points
    E.5.1Primary end point(s)
    Durable Complete response
    tasso di risposta completa
    E.5.1.1Timepoint(s) of evaluation of this end point
    Approximately 12 months from the start of treatment
    Circa 12 mesi da inizio trattamento
    E.5.2Secondary end point(s)
    Overall Response Rate (ORR), progression free survival (PFS), time to
    treatment failute, duration fo response (CR and PR), Safety,Immunogenicty, and Pharmokokinetics
    tasso di risposta complessivo (ORR, Overall Response Rate), la sopravvivenza libera da progressione (PFS, Progression-free Survival), il tempo all'insuccesso del trattamento (TTF, Time to Treatment Failure), la durata della risposta (CR e risposta parziale [PR, Partial Response]), la sicurezza,immunogenicit¿ e farmacocinetica
    E.5.2.1Timepoint(s) of evaluation of this end point
    Duration of study
    Durata dello studio
    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 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. 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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E. trial design description
    in aperto
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United Kingdom
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 Yes
    F. of other specific vulnerable populations
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 56
    F.4.2.2In the whole clinical trial 77
    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)
    Standard of Care
    Terapia Standard
    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 Decision2015-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-11
    P. End of Trial
    P.End of Trial StatusCompleted
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