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    Summary
    EudraCT Number:2011-002566-21
    Sponsor's Protocol Code Number:CD-ON-MEDI-551-1019
    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:2012-08-07
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-002566-21
    A.3Full title of the trial
    A Phase 2 Open-label Study of MEDI-551 and Bendamustine vs Rituximab and Bendamustine in Adults With Relapsed or Refractory CLL
    Studio in aperto di fase 2 su MEDI-551 e bendamustina rispetto a rituximab e bendamustina in adulti con LLC recidivante o refrattaria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Open-label Study of MEDI-551 and Bendamustine vs Rituximab and Bendamustine in Adults With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
    Studio di fase 2 in aperto su MEDI-551 e bendamustina rispetto a rituximab e bendamustina in adulti con Leucemia linfocitica cronica (LLC) recidivante o refrattaria
    A.4.1Sponsor's protocol code numberCD-ON-MEDI-551-1019
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01466153
    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 ONCOLOGY INC
    B.1.3.4CountryNetherlands
    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 AddressOne MedImmune Way
    B.5.3.2Town/ cityGaithersburg
    B.5.3.3Post code20878
    B.5.3.4CountryUnited States
    B.5.4Telephone number301 398-4012
    B.5.5Fax number301 398-9012
    B.5.6E-mailclinicaltrialenquiries@medimmune.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 nameMEDI-551
    D.3.2Product code MEDI-551
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeMEDI-551
    D.3.9.3Other descriptive namea-fucosylated anti-CD19 antibody
    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 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 Yes
    D.3.11.13.1Other medicinal product typeAnticorpo Monoclonale
    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 nameMEDI-551
    D.3.2Product code MEDI-551
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeMEDI-551
    D.3.9.3Other descriptive namea-fucosylated anti-CD19 antibody
    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 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 Yes
    D.3.11.13.1Other medicinal product typeAnticorpo Monoclonale
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Registration Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical 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.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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 Yes
    D.3.11.13.1Other medicinal product typeAnticorpo monoclonale
    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
    Relapsed or refractory chronic lymphocytic leukemia (CLL)
    leucemia linfocitica cronica recidivante o refrattaria (LLC)
    E.1.1.1Medical condition in easily understood language
    Relapsed or refractory chronic lymphocytic leukemia (CLL)
    leucemia linfocitica cronica recidivante o refrattaria (LLC)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10008976
    E.1.2Term Chronic lymphocytic leukemia
    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
    The overall purpose of the study is to determine if MEDI-551, when used in combination with salvage chemotherapy (bendamustine) in patients with relapsed or refractory CLL who are not eligible for Autologous Stem Cell Transplant (ASCT), has superior efficacy compared to rituximab in the same population.
    L'obiettivo generale dello studio è determinare se MEDI-551, quando usato in combinazione con la chemioterapia di salvataggio (bendamustina) in pazienti affetti da LLC recidiva o refrattaria, che non sono eleggibili per il trapianto autologo di cellule staminali (ASCT), ha una efficacia superiore rispetto a rituximab nella stessa popolazione.
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability, antitumor activity, overall survival, pharmakokinectics and immunogenicity of MEDI-551 when used in combination with Bendamustine
    Per valutare la sicurezza e la tollerabilità,l'attività antitumorale,la sopravvivenza globale,farmacocinetica e immunogenicità di MEDI-551 quando usato in combinazione con bendamustina
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Histologically confirmed aggressive B-cell Chromic Lymphocytic Leukemia( CLL) according to the National Cancer Institute criteria •Adequate hematological function
    •leucemia linfocitica cronica a cellule B aggressive istologicamente confermata secondo i criteri del National Cancer Institute •adeguata funzionalità ematologica
    E.4Principal exclusion criteria
    • Any chemotherapy, radiotherapy, immunotherapy, biologic, investigational or hormonal therapy for treatment of lymphoma within 42 days prior to treatment • Exposure to Bendamustine within 180 days before study enrollment • Any active secondary malignancy • Prior autologous or allogeneic stem cell transplantation SCT • Clinically significant abnormality on ECG • History of other invasive malignancy within 5 years except for localized/in situ, carcinomas such as cervical carcinoma in situ or basal/squamous skin cancer. • Evidence of active infection • Documented current central nervous system involvement by leukemia or lymphoma
    •Qualsiasi chemioterapia, radioterapia, immunoterapia, biologica, ormonale o terapia sperimentale per il trattamento del linfoma entro 42 giorni prima del trattamento •L'esposizione a bendamustina entro 180 giorni precedenti l'arruolamento dello studio •Qualsiasi tumore maligno secondario attivo •Precedente trapianto SCT allogenico o autologo di cellule staminali •Anomalia dell' ECG clinicamente significativa •Storia di altre neoplasie invasive entro 5 anni, tranne per i carcinomi localizzati/in situ, come il carcinoma cervicale in situ o il cancro della pelle basale/squamoso. •Prove di infezione attiva •Coinvolgimento attuale e documentato del sistema nervoso centrale da leucemia o linfoma
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation of the Overall Response Rate (ORR), including Complete Response (CR) and Partial Response (PR), in adult subjects with relapsed or refractory CLL treated with up to 6 cycles of MEDI-551 in combination with bendamustine versus rituximab in combination with bendamustine.
    Valutazione della ORR, definita come la percentuale di soggetti adulti con LLC recidivante o refrattaria che manifestano una risposta completa o parziale trattati fino a 6 cicli di MED-551 in combinazione con bendamustina rispetto a rituximab in combinazione con bendamustina.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 720
    720 Giorni
    E.5.2Secondary end point(s)
    Antitumor activity: Includes Complete Response (CR) rate, Minimal Residual Disease (MRD) negative CR rate, Time to Response (TTR), Time to Progression (TTP), Progression Free Survival (PFS); Overall Survival (OS). Acceptable Dose: Benefit/Risk Analysis of Safety and Efficacy to be determined. Safety and Tolerability: The safety endpoints include Adverse Events (AEs), Serious Adverse Events (SAEs) occurring during the protocol specified reporting period and changes in clinical laboratory evaluations, Electrocardiogram (ECGs), vital signs, and weight from baseline. Immunogenicity (IM): Number and percentage of subjects who develop detectable anti-drug antibodies Pharmacokinetics (PK): Area Under Curve, CMAX, T1-half, Clearance (CL)
    Attività antitumorale: Include il tasso di risposta completa (CR), il tasso di CR negativa senza malattia residua minima (MRD), il tempo alla risposta (TTR), il tempo alla progressione (TTP), la sopravvivenza libera da progressione (PFS) e la sopravvivenza globale (OS). Dose Accettabile: valutazione del rischio/beneficio della sicurezza e dell'efficacia da determinare. Sicurezza e tollerabilità: Gli endpoint di sicurezza includono eventi avversi (EA), eventi avversi seri (SAE) che si verificano durante il periodo specificato dal protocollo e i cambiamenti rispetto al basale nei risultati di laboratorio clinico, negli elettrocardiogrammi (ECG) e nei segni vitali e nel peso. Immunogenicità (IM): Numero e percentuale di soggetti che sviluppano anticorpi anti-farmaco rilevabili. Farmacocinetica (PK): area sotto la curva, CMAX, T1-mezzo, la clearance (CL)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Antitumor activity: Study Day 720 Acceptable dose: Study Day 56 Safety and Tolerability: Study Day 720 IM: Up to Study Day 720 PK: Study Day 1, Study Day 8, Study Day 15, Study Day 22, Study Day 29, Study Day 57, Study Day 85, Study Day 113, Study Day 141, Study Day 169, Study Day 197, Study Day 227, Study Day 255
    Attività antitumorale: giorno 720 Dose accettabile: giorno 56 Sicurezza e tollerabilità: giorno 720 IM: fino al giorno 720 PK: giorno 1, 8, 15, 22, 29, 57, 85, 113, 141, 169, 197, 227, 255
    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.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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    rituximab - Stesso farmaco ad altro dosaggio
    rituximab - same IMP used at different dosage
    E.8.2.4Number of treatment arms in the trial3
    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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    Canada
    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
    The end of the study (''study completion'') is defined as the date of the last protocol-specified visit/assessment (including telephone contact) for the last subject in the study. This date will be after a combined total of 82 deaths occur in the rituximab arm and the selected MEDI-551 arm, or 24 months from the date the last subject is randomized into the study, or the date the sponsor stops the study, whichever occurs first.
    La fine dello studio è definita come la data dell'ultima visita/valutazione specificata dal protocollo(compreso il contatto telefonico) per l'ultimo paziente.Questa data sarà dopo82decessi totali avvenuti in un braccio o 24 mesi dalla LPI.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months68
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days68
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    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 state33
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 84
    F.4.2.2In the whole clinical trial 156
    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)
    na
    na
    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 Decision2012-05-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-01-08
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