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    Summary
    EudraCT Number:2011-002810-35
    Sponsor's Protocol Code Number:LEBEN
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-03-01
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-002810-35
    A.3Full title of the trial
    A Phase 1/2 Study of Lenalidomide in combination with Bendamustine (LEBEN) in relapsed and primary refractory Hodgkin Lymphoma
    Studio di Fase 1/2 sull'utilizzo di Lenalidomide in combinazione con Bendamustina (LEBEN) in pazienti affetti da Linfoma di Hodgkin recidivo e refrattario
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1/2 Study of Lenalidomide in combination with Bendamustine (LEBEN) in relapsed and primary refractory Hodgkin Lymphoma
    Studio di Fase 1/2 sull’utilizzo di Lenalidomide in combinazione con Bendamustina (LEBEN) in pazienti affetti da Linfoma di Hodgkin recidivo e refrattario
    A.4.1Sponsor's protocol code numberLEBEN
    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 SponsorISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE "G. PASCALE"
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCelgene
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportMundipharma
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE
    B.5.2Functional name of contact pointEmatologia Oncologica
    B.5.3 Address:
    B.5.3.1Street AddressVia M. Semmola
    B.5.3.2Town/ cityNapoli
    B.5.3.3Post code80131
    B.5.3.4CountryItaly
    B.5.4Telephone number081 5903 671/382
    B.5.5Fax number081 5903 833
    B.5.6E-mailemadata.pascale@tin.it
    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 REVLIMID*21CPS 10MG
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) 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: 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 Yes
    D.2.1.1.1Trade name RIBOMUSTIN*1F 100MG
    D.2.1.1.2Name of the Marketing Authorisation holderMUNDIPHARMA PHARMACEUTIC.Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Powder and solvent 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 INNNA
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) 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
    relapsed and primary refractory Hodgkin Lymphoma
    pazienti affetti da Linfoma di Hodgkin recidivo e refrattario
    E.1.1.1Medical condition in easily understood language
    relapsed and primary refractory Hodgkin Lymphoma
    pazienti affetti da Linfoma di Hodgkin recidivo e refrattario
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10020328
    E.1.2Term 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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the best tolerated and effective dose (dose finding) for oral Lenalidomide among 10, 15, 20 e 25 mg dose levels in a 28-day cycle, as associated to a fixed dose of weekly bendamustine (60 mg/m2 on days 1, 8 and 15), based on the best trade-off between toxicity and efficacy according to the Bayesian phase I/II dose finding method of Thall and Cook in subjects with Recurrent Hodgkin Lymphoma
    Determinare la dose orale meglio tollerata ed efficace (dose finding) di Lenalidomide scegliendo tra quattro livelli di dosaggio (10, 15, 20 e 25 mg/die) in un ciclo di 28 giorni associata ad una dose prestabilita di Bendamustina (60 mg/m2 nei giorni 1, 8 e 15), basata sulla strategia del trade-off tra tossicità ed efficacia in accordo al metodo Bayesiano del dose finding di Thall and Cook per gli studi di Fase 1/2 in pazienti con Linfoma di Hodgkin ricorrente
    E.2.2Secondary objectives of the trial
    1. To evaluate the safety profile of lenalidomide in combination with bendamustine in terms of AE/SAE rate
    2. To evaluate the antitumor activity of lenalidomide in combination with bendamustine in terms of ORR, TTP, PFS and response duration
    1. Valutare il profilo di sicurezza di Lenalidomide in associazione con Bendamustina in termini di rapporto AE/SAE
    2. Valutare l’attività antitumorale della Lenalidomide in combinazione con Bendamustina in termini di ORR, TTP, PFS e durata della risposta.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients must have histologically confirmed classical Hodgkin lymphoma (HL).
    - Patients must have failed an autologous stem cell transplant or be ineligible for high-dose therapy due to chemorefractory disease (as defined as <50% response to standard salvage chemotherapy), age or comorbidity.
    - Patients must have at least one target PET-avid bidimensionally measurable lesion,
    - Age >18 years
    - Life expectancy of greater than 3 months
    - ECOG performance status <2
    - Patients must have adequate organ and marrow function as defined below:
    - absolute neutrophil count >1,000/L
    - platelets >75,000/L
    - total bilirubin < 2.0 mg/dl in the absence of a history of Gilbert's disease (or pattern consistent with Gilbert's); however dose reduction is recommended for Bendamustine. in patients with 30 – 70 % tumour involvement of the liver and moderately diminished liver function (serum bilirubin 1.2 – 3.0 mg/dl).
    - AST(SGOT)/ALT(SGPT) <3 X institutional upper limit of normal
    - creatinine within normal institutional limits OR creatinine clearance >50 mL/min/1.73 m2
    - Patients must have echocardiogram or gated blood pool scan (MUGA) with an ejection fraction > or = to 50%
    - If patients have a history of malignancy other than cutaneous basal cell or squamous cell carcinoma, they must be disease-free for ~ 5 years at the time of enrolment
    - Patients must accept contraception measures until 4 weeks after the completion of chemotherapy, and up to 6 months for male patients.
    - Women of child-bearing must have a medically supervised negative pregnancy test even if had been using effective contraception.
    - Patients agree not to share study medication with another person and to return all unused study drug to the investigator
    - Patients or their guardians must be capable to understand and must be willing to sign a written informed consent document
    -Pazienti con conferma istologica di Linfoma di Hodgkin (HL).
    -Pazienti con fallimento di ASCT o non eleggibili a terapie ad alte dosi per malattia chemorefrattaria (definite come &lt;50% della risposta alla tarapia standard di salvataggio), età o comorbidità.
    -Pazienti con almeno una lesione misurabile tramite PET,
    -Età &gt;18 anni
    -Aspettativa di vita &gt; di 3 mesi
    -ECOG performance status &lt;2
    -Pazienti con adeguate funzionalità d’organo e midollari definite come:
    -Conta neutrofilica assoluta &gt;1,000/L
    -Piastrine &gt;75,000/L
    -Bilirubina tot &lt; 2.0 mg/dl in assenza di malattia di Gilbert's (o modello coerentecon Gilbert); la riduzione della dose di Bendamustina è raccomandata in pazienti con 30 – 70 % di convolgimento di tumore del fegato o moderata ridotta funzionalità del fegato (bilirubina sierica 1.2 – 3.0 mg/dl).
    - AST(SGOT)/ALT(SGPT) &lt;3 X limite superiore di normalità
    -Creatinina nei range di normalità O clearance creatinica&gt;50 mL/min/1.73 m2
    -Pazienti con ecocardiogramma o MUGA con una frazione di eiezione cardiaca &gt; o = a 50%
    -Pazienti con almeno 5 anni di sopravvivenza libera malattia al momento dell’arruolamento in caso di storia di pregresso tumore ad esclusione del tumore cutaneo delle cellule basali o carcinoma delle cellule squamose
    -Pazienti che acconsentono all’utilizzo di metodi contraccettivi fino a 4 settimane dopo il completamento della chemioterapia e fino a sei mesi per i pazienti di sesso maschile.
    -Donne fertile con test di gravidanza negativo, anche se utilizzano metodi contraccettivi.
    -Pazienti che acconsentono di non condividere il farmaco in studio con altre persone e che acconsentono di restituire il farmaco inutilizzato agli investigatori.
    -Pazienti in grado di intendere e di volere e che abbiano firmato il consenso informato per partecipare allo studio
    E.4Principal exclusion criteria
     Treatment with chemotherapy or external radiotherapy within 6 weeks, or monoclonal antibodies within 8 weeks or radio-immunoconiugates in the previous 12 weeks prior to entering the study
     Treatment with any other investigational agent
     Parenchymal brain or leptomeningeal HL involvement
     History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in the study
     Known HIV positivity or active infectious hepatitis, type A, B, or C
     Clinically significant cardiac disease (NYHA Class III or IV)
     Abnormal QTcF interval prolonged (> 459 msec)
    - Known pregnancy or breastfeeding.
    - Jaundice
     Yellow fever vaccination
     Medical illness unrelated to HL, which in the opinion of the attending physician and principal investigator will preclude safe administration of lenalidomide and bendamustine
     Corticoid treatment different from low dose prednisone or methylprednisone (up to 16 mg), used for B symptoms control.
     Controindications for receiving prophylaxis against deep vein thrombosis
     Thromboembolic disease grade 3-4 in the last 6 months
     More than one month between staging procedures and the start of the treatment
     Major surgical procedures less than 30 days before the start of treatment
     Pazienti trattati con chemioterapia o radioterapia nelle 6 settimane, o anticorpi monoclonali nelle 8 settimane o radio-immunoconiugati nelle 12 settimane prima di entrare nello studio.
     Pazienti trattati con altri farmaci sperimentali.
     Pazienti con coinvolgimento del parenchima cerebrale o HL leptomeningeo
     Pazienti ipersensibili ad agenti con struttura chimica o composizione biologica simile ai farmaci usati nello studio.
     Nota positività al virus HIV o infezione attiva da epatite tipo A, B, o C.
     Pazienti con compromissione cardiaca clinicamente significativa (NYHA Classe III o IV)
     Pazienti con intervallo QTcF allungato (&gt; 459 msec)
     Pazienti gravide o in allattamento.
     Pazienti con Ittero
     Pazienti con vaccino per la febbre gialla
     Condizioni generali scadenti non correlabili al Linfoma che possono precludere la sicurezza del paziente nella somministrazione di Lenalidomide e Bendamustina.
     Trattamento con corticosteroidi diversi da prednisone o metilprednisone a basse dosi (fino a 16 mg) usati per i sintomi B. .
     Pazienti con controindicazioni per la profilassi della trombosi venosa profonda.
     Patologia tromboembolica di grado 3-4 negli ultimo 6 mesi.
     Più di un mese dalla procedura di staging e le procedure di inizio trattamento.
     Procedure chirurgiche di entità maggiore nei 30 giorni prima del trattamento
    E.5 End points
    E.5.1Primary end point(s)
    NA
    migliore dose tollerata in grado di dare risposta terapeutica
    E.5.1.1Timepoint(s) of evaluation of this end point
    NA
    NA
    E.5.2Secondary end point(s)
    • Overall Response rate (CR+PR)
    • Time to Progression
    • Event free Survival
    • Response duration (see section 11.0)
    ORR, TTP, PFS e durata della risposta
    E.5.2.1Timepoint(s) of evaluation of this end point
    na
    na
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised 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 Yes
    E.8.2.3.1Comparator description
    - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    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 concerned9
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    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 months18
    E.8.9.1In the Member State concerned days0
    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: 32
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state36
    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 Decision2011-12-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-20
    P. End of Trial
    P.End of Trial StatusOngoing
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