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    The EU Clinical Trials Register currently displays   43931   clinical trials with a EudraCT protocol, of which   7307   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:2014-000999-26
    Sponsor's Protocol Code Number:13-006
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-07-22
    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 number2014-000999-26
    A.3Full title of the trial
    An Open-Label, Single-Arm, Multicenter Pharmacokinetic Study of Intramuscular Erwinaze® (asparaginase Erwinia chrysanthemi)/Erwinase® (crisantaspase) Administered Following Hypersensitivity to E. coli Asparaginase in Young Adults with Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
    Estudio farmacocinético multicéntrico, sin enmascaramiento y con un solo grupo de tratamiento, de Erwinaze® (asparaginasa de Erwinia chrysanthemi)/Erwinase® (crisantaspasa), administrados por vía intramuscular tras la aparición de hipersensibilidad a asparaginasa de E. coli en adultos jóvenes con leucemia linfoblástica aguda o linfoma linfoblástico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open label, single arm, multicenter pharmacokinetic study designed to investigate the serum asparaginase activity associated with the administration of Erwinase dosed intramuscularly in young adult subjects diagnosed with Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LBL) with a documented hypersensitivity reaction to native E.coli Asparginase
    Estudio farmacocinético multicéntrico, sin enmascaramiento y con un solo grupo de tratamiento diseñado para investigar la actividad de la asparaginasa sérica asociada a la administración de Erwinase por vía intramuscular en pacientes adultos jóvenes con diagnóstico de leucemia linfoblástica aguda (LLA) o linfoma linfoblástico (LL) que hayan presentado una reacción de hipersensibilidad documentada a la asparaginasa nativa de E. coli
    A.4.1Sponsor's protocol code number13-006
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02150928
    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 SponsorJazz Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJazz Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJazz Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointBengt Bergstrom
    B.5.3 Address:
    B.5.3.1Street Address3180 Porter Drive
    B.5.3.2Town/ cityPalo Alto
    B.5.3.3Post codeCA 94304
    B.5.3.4CountryUnited States
    B.5.4Telephone number+3493547 5533
    B.5.5Fax number+1650 4962871
    B.5.6E-mailbengt.bergstrom@jazzpharma.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 Yes
    D.2.1.1.1Trade name Erwinase
    D.2.1.1.2Name of the Marketing Authorisation holderEUSA Pharma SAS
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameErwinase
    D.3.4Pharmaceutical form Powder for solution 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 INNcrisantaspase
    D.3.9.1CAS number 1349719-22-7
    D.3.9.3Other descriptive nameCRISANTASPASE
    D.3.9.4EV Substance CodeSUB33789
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10000
    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
    1) Acute Lymphoblastic Leukemia
    2) Lymphoblastic Lymphoma
    1) Leucemia linfoblástica aguda (LLA)
    2) Linfoma linfoblástico (LL)
    E.1.1.1Medical condition in easily understood language
    1) Acute Lymphoblastic Leukemia (form of blood cancer characterised by excess of immature white blood cells), 2) Lymphoblastic Lymphoma (form of blood cancer, result of abnormal adaptive immune cells)
    1) LLA (tipo de cáncer de la sangre caracterizado por un exceso de glóbulos blancos inmaduros), 2) LL (tipo de cáncer de la sangre, resultado de una adaptación anormal de las células inmunitarias)
    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 17.0
    E.1.2Level LLT
    E.1.2Classification code 10000845
    E.1.2Term Acute lymphoblastic leukemia
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level HLT
    E.1.2Classification code 10036544
    E.1.2Term Precursor T-lymphoblastic lymphomas/leukaemias
    E.1.2System Organ Class 100000004851
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level HLT
    E.1.2Classification code 10036524
    E.1.2Term Precursor B-lymphoblastic lymphomas
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the proportion of subjects with 2-day nadir serum asparaginase activity (NSAA) levels (48-hour levels taken after the 5th dose) that are ? 0.1 IU/mL in the first 2 consecutive weeks of Erwinase treatment
    Determinar la proporción de sujetos con niveles mínimos de actividad de la asparaginasa sérica (NMAS) > 0,1 UI/ml a los 2 días (los niveles a las 48 horas se determinarán después de administrar la 5.ª dosis) durante las 2 primeras semanas consecutivas de tratamiento con Erwinase.
    E.2.2Secondary objectives of the trial
    To determine the proportion of subjects with 3-day NSAA levels (72-hour levels taken after the 6th dose) that are ? 0.1 IU/mL in the first 2 consecutive weeks of Erwinase treatment.
    ? To describe the NSAA over time following repeated administration of Erwinase
    ? To evaluate the safety of Erwinase in young adult subjects as follows:
    - To describe the incidence and severity of asparaginase-related toxicities
    - To measure the presence of anti-Erwinase antibodies and neutralizing antibody responses
    ? Determinar la proporción de sujetos con NMAS a los 3 días > 0,1 UI/ml (los niveles a las 72 horas se determinarán después de administrar la 6.ª dosis) durante las 2 primeras semanas consecutivas de tratamiento con Erwinase.
    ? Describir el NMAS a lo largo del tiempo tras la administración repetida de Erwinase
    ? Evaluar la seguridad de Erwinase en los adultos jóvenes, de la siguiente forma:
    - Describir la incidencia y la intensidad de las toxicidades relacionadas con la asparaginasa
    - Determinar la presencia de anticuerpos anti-Erwinase y las respuestas a los anticuerpos neutralizantes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Have a diagnosis of ALL or LBL
    2. Be 18 to <40 years of age at the time of enrollment
    3. Have a documented ? Grade 2 clinical hypersensitivity reaction to native E. coli asparaginase (e.g., Elspar or Kidrolase) or pegaspargase (Oncaspar)
    4. Have the following asparaginase doses remaining in their treatment plan:
    - At least two (2) consecutive weeks of native E. coli asparaginase treatment OR
    - At least one (1) dose of pegaspargase (Oncaspar)
    5. Have a direct bilirubin ? Grade 2 (<3.0 mg/dL [52 ?mol/L])
    6. Have amylase and lipase within normal limits (per institutional standards)
    7. Have a serum asparaginase activity below the detectable limit during screening prior to the first dose of study drug (Erwinase)
    8. Consent to use a medically acceptable method of contraception throughout the entire study period and for 4 weeks after the study is completed. Medically acceptable methods of contraception that may be used by the subject and/or the partner include abstinence, birth control pills or patches, diaphragm and spermicide, condom and vaginal spermicide, surgical sterilization, postmenopausal, vasectomy (>6 months prior to baseline), and progestin implant or injection.
    9. Have signed informed consent
    1. Haber recibido el diagnóstico de LLA o LL
    2. Edad entre 18 y < 40 años en el momento de la inclusión en el estudio
    3. Haber presentado una reacción de hipersensibilidad clínicamente documentada > grado 2 a la asparaginasa de E. coli nativa (por ejemplo, Elspar o Kidrolase) o a la pegaspargasa (Oncaspar)
    4.Tener las siguientes administraciones de asparaginasa pendientes en su plan de tratamiento:
    - Dos (2) semanas consecutiva, como mínimo, de tratamiento con asparaginasa nativa de E. coli, O BIEN
    - Una (1) administración, como mínimo, de pegaspargasa (Oncaspar)
    5. Presentar un valor de bilirrubina directa ? grado 2 (< 3,0 mg/dl [52 ?mol/l])
    6. Presentar unos valores de amilasa y lipasa dentro de los límites de normalidad (de acuerdo con los valores de referencia del centro)
    7. Presentar una actividad de la asparaginasa sérica por debajo de los límites detectables durante la selección previa a la primera administración del fármaco del estudio (Erwinase)
    8. Estar de acuerdo en utilizar un método anticonceptivo médicamente aceptable durante todo el período del estudio, así como durante las 4 semanas posteriores a la finalización del mismo. Los métodos anticonceptivos médicamente aceptables que el sujeto o su pareja pueden emplear son: abstinencia completa, anticonceptivos orales o en parches, diafragma junto con espermicidas, preservativo junto con espermicidas vaginales, esterilización quirúrgica, posmenopausia, vasectomía (practicada con más de 6 meses de anterioridad respecto al inicio del estudio) y los implantes o inyecciones de progesterona.
    9. Haber firmado el documento de consentimiento informado
    E.4Principal exclusion criteria
    1. Prior history of ?Grade 3 pancreatitis
    2. Prior history of a major thrombotic event as assessed by the investigator, or any subject with a history of asparaginase-associated serious hemorrhagic or thrombotic event requiring prolonged anticoagulation therapy with agents such as heparin
    3. Prior treatment with Erwinase
    4. Pregnant or lactating female subjects or female subjects of childbearing potential not willing to use an adequate method of birth control (listed above) for the duration of the study
    5. Subjects with a history of human immunodeficiency virus (HIV) or hepatitis.
    6. Any other condition that would cause a risk (in the investigator?s judgment) to subjects if they participate in the trial
    1. Antecedentes de pancreatitis ? grado 3
    2. Antecedentes de episodios tromboembólicos importantes (según la evaluación del investigador) o de cualquier episodio hemorrágico o tromboembólico grave asociado a la asparaginasa que haya requerido anticoagulación prolongada con fármacos como la heparina
    3. Tratamiento previo con Erwinase
    4. Mujeres embarazadas o en período de lactancia, así como las mujeres en edad fértil que no deseen utilizar un método anticonceptivo adecuado (de los anteriormente mencionados) durante la totalidad del estudio
    5. Sujetos con antecedentes de infección por el virus de la inmunodeficiencia humana (VIH) o de hepatitis.
    6. Cualquier otra patología que pudiese suponer un riesgo (a criterio del investigador) para los sujetos en caso de participar en el ensayo
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is the proportion of subjects with 2-day NSAA levels (measured 48 hours after the 5th dose) that are ? 0.1 IU/mL in the first 2 consecutive weeks of Erwinase treatment.
    Determinar la proporción de sujetos con niveles mínimos de actividad de la asparaginasa sérica (NMAS) > 0,1 UI/ml a los 2 días (los niveles a las 48 horas se determinarán después de administrar la 5.ª dosis) durante las 2 primeras semanas consecutivas de tratamiento con Erwinase.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 48 hours after the 5th dose
    a las 48 horas después de administrar la 5.ª dosis
    E.5.2Secondary end point(s)
    - Proportion of subjects with 3-day NSAA levels (72 hour levels taken after the 6th dose) that are ? 0.1 IU/mL in the first 2 consecutive weeks of Erwinase treatment
    - NSAA levels over time following repeated administration of Erwinase
    - Determinar la proporción de sujetos con NMAS a los 3 días > 0,1 UI/ml (los niveles a las 72 horas se determinarán después de administrar la 6.ª dosis) durante las 2 primeras semanas consecutivas de tratamiento con Erwinase.
    - Describir el NMAS a lo largo del tiempo tras la administración repetida de Erwinase
    E.5.2.1Timepoint(s) of evaluation of this end point
    at 72 hours taken after the 6th dose
    a las 72 horas después de administrar la 6.ª dosis
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Poland
    Spain
    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
    Última visita del último paciente
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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: 30
    F.1.3Elderly (>=65 years) No
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 30
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    none
    ninguno
    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 Decision2014-09-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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