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    Summary
    EudraCT Number:2010-021253-39
    Sponsor's Protocol Code Number:SAKK35/10
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-01-12
    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 number2010-021253-39
    A.3Full title of the trial
    Rituximab plus lenalidomide or rituximab monotherapy for untreated patients with follicular lymphoma in need of therapy. A randomized, open-label, multicentre phase II trial
    Studio open label, di fase II multicentrico randomizzato con rituximab piu' lenalidomide o rituximab in monoterapia per pazienti precedentemente non trattati affetti da linfoma follicolare con necessita' di trattamento
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of rituximab with lenalidomide or rituximab alone for patients with follicular lymphoma.
    Trattamento con rituximab e lenalidomide o rituximab da solo per pazienti affetti da linfoma folliculare.
    A.4.1Sponsor's protocol code numberSAKK35/10
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01307605
    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 SponsorSAKK - GRUPPO SVIZZERO DI RICERCA CLINICA SUL CANCRO
    B.1.3.4CountrySwitzerland
    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.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportSAKK Gruppo Svizzero di Ricerca Clinica sul Cancro
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSAKK
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressEffingerstrasse 40
    B.5.3.2Town/ cityBern
    B.5.3.3Post code3008
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41 31 389 91 91
    B.5.5Fax number+41 31 389 92 00
    B.5.6E-mailsakkcc@sakk.ch
    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 5MG
    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 Capsule, hard
    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 INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.4EV Substance CodeSUB21032
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 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 Capsule, hard
    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 INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.4EV Substance CodeSUB21032
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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: 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 REVLIMID*21CPS 15MG
    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 Capsule, hard
    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 INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.4EV Substance CodeSUB21032
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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
    Patients having follicular lymphoma in need of therapy
    Pazienti affetti da linfoma follicolare che necessita di trattamento
    E.1.1.1Medical condition in easily understood language
    follicular lymphoma in need of therapy
    linfoma follicolare che necessita di trattamento
    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 10059432
    E.1.2Term Follicular mixed small and large cell 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
    To determine the activity of the combination of rituximab and lenalidomide given to untreated follicular lymphoma patients versus rituximab treatment
    Determinare l’attività della combinazione di rituximab e lenalidomide somministrata a pazienti affetti da linfoma follicolare paragonata al trattamento con rituximab
    E.2.2Secondary objectives of the trial
    Safety of the two therapy arms.
    Sicurezza dei due bracci di trattamento
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    OTHER SUBSTUDIES:
    Ricerca traslazionale: la raccolta di materiale biologico per analisi future.
    ALTRI SOTTOSTUDI:
    Ricerca traslazionale: ricerca su campioni biologici di pazienti affetti da linfoma follicolare. Ricerca di marcatori prognostici e predittivi per questa malattia
    E.3Principal inclusion criteria
    -Histologically confirmed FL CD20+; grade 1, 2, 3a; stage III+IV; stage II not suitable for radiotherapy -Patients in need of systemic therapy: (at least one of these indications must be fulfilled) •symptomatic enlarged lymph nodes, spleen or other lymphoma manifestations •bulky disease ≥ 6 cm in long diameter •clinically significant progression over at least 6 months of any tumor lesion •anemia (Hb < 100 g/L) or thrombocytopenia (Platelets < 100 x 109/L) due to lymphoma •clinically significant progressive decrease in Hb or platelet count due to lymphoma •B-symptoms ,weight loss > 10 % in 6 months, drenching night sweats or fever > 38°C not due to infection -Patients must have at least one two-dimensionally measurable lesion with longest transverse diameter > 10 mm -Paraffin embedded tumor tissue is available for sending for pathology review -Age > 18 years -WHO performance status 0-2 -For patients with history of cardiac disease or older than 70 years: adequate cardiac function must be confirmed by EF ≥ 50% -Adequate hematological values unless due to marrow infiltration by FL: (Neutrophils ≥ 1.5 x 109/l, Platelets ≥ 100 x 109/l) -Adequate hepatic function: Bilirubin ≤ 1.5 x ULN (unless due to Gilbert’s syndrome), ALT/AP ≤ 2.5 x ULN -Adequate renal function (calculated creatinine clearance ≥ 30 ml/min, according to the formula of Cockroft- Gault) -Patient must give written informed consent before randomization -Patient compliance and geographic proximity allow proper staging and follow-up -Women with Childbearing potential •are not pregnant and agree not to become pregnant during participation in the trial and during the 12 months thereafter •are using effective contraception since 30 days at least •have a negative pregnancy test within 4 days before randomization -Men agree not to father a child, not to donate semen and to use condoms during trial treatment and 12 months thereafter -Patients (male and female) agree to follow the special pregnancy prevention requirements for Revlimid (lenalidomide)
    • -conferma istologica: linfoma follicolare CD20+, grado 1, 2, 3a, Stadio III+ IV; stadio II non eleggibile per radioterapia- Pazienti che necessitano di una terapia sistemica: ( almeno una delle seguenti condizioni deve essere soddisfatta) •Presenza di linfonodi aumentati di volume e sintomatici,splenomegalia o altre menifestazioni cliniche riferibili al linfoma • Presenza di malattia “bulky” di diametro ≥ 6 cm maggiore • progressione clinica significativa di qualsiasi lesione tumorale negli ultimi 6 mesi •anemia (Hb &lt; 100 g/L) o trombocitopenia (piastrine &lt; 100 x 109/L) causate dal linfoma • sintomi B( perdita di peso &gt; 10% in 6 mesi, sudorazioni notturne molto abbondanti oppure febbre &gt; 38°C non dovuta a un’infezione) I pazienti devono avere almeno una lesione misurabile in due dimensioni con un diametro Massimo trasversale &gt; 10 mm - Disponibilità di tessuto tumorale conservato in paraffina da inviare per una revisione istopatologica centralizzata- Età &gt; 18 anni- performance status secondo WHO 0-2- Per pazienti con storia di patologie cardiocircolatorie oppure per pazienti con piu’ di 70 anni: funzione cardiaca adeguata confermata da un FE ≥ 50% - valori ematologici adeguati se non dovuti a un infiltrazione midollare da parte del linfoma follicolare: (neutrofili ≥ 1.5 x 109/l, piastrine ≥ 100 x 109/l) - Valori di funzionalità epatica adeguati: bilirubina ≤ 1.5 x ULN (eccetto per pazienti affetti da dalla sindrome di Gilbert), ALT/AP ≤ 2.5 x ULN - Funzione renale adeguata (clearance creatininica calcolata ≥ 30 ml/min, secondo la formula di Cockroft- Gault) – Il paziente deve dare il suo consenso scritto prima di essere randomizzato nello studio- Disponibilità del paziente e sua vicinanza geografica al centro di trattamento al fine di poter effettuare un’adeguata stadizione e le visite di follow-up - Donne in età fertile: devono rispettare i seguenti criteri: • non essere in stato di in gravidanza e accettare di non intraprendere una gravidanza durante la partecipazione allo studio e nei 12 mesi successivi • utilizzare da almeno 30 giorni prima dell’inizio del trattamento una contraccezione efficace • eseguire un test di gravidanza entro 4 giorni prima della randomizzazione -Soggetti maschili: devono rispettare i seguenti criteri: accettare di non procreare, di non donare sperma e di usare il preservativo durante la partecipazione allo studio e nei 12 mesi successivi -I Pazienti (uomini e donne) devono accettare di seguire le precauzioni specifiche richieste durante l’utilizzo di Revlimid per prevenire una gravidanza (lenalidomide)
    E.4Principal exclusion criteria
    -Previous systemic therapy for follicular lymphoma -Radiotherapy within the last 3 months -Known CNS involvement -Any serious underlying medical condition (at the judgment of the investigator) which could impair the ability of the patient to participate in the trial (e.g. active autoimmune disease, uncontrolled diabetes) -Previous malignancy within 5 years with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer -Psychiatric disorder precluding understanding information of trial related topics, giving informed consent, or interfering with compliance for oral drug intake -Known hypersensitivity to trial drug(s) or hypersensitivity to any other component of the trial drugs -Any concomitant drugs contraindicated for use with the trial drugs according to the approved product information -Concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment in a clinical trial within 30 days prior to trial entry -Known HIV+ infection or HCV infection -Patients with any serological evidence of current or past hepatitis B, unless the serological findings are clearly due to vaccination -Patients regularly taking corticosteroids during the last 4 weeks, unless administered at a dose equivalent to Prednisone ≤ 15 mg/day for indications other than lymphoma or lymphoma-related symptoms -Pregnant or lactating females -Patients in need of urgent chemotherapy, e.g. because of existing or imminent compression
    precedente trattamento sistemico per il linfoma follicolare- radioterapia negli ultimi 3 mesi- noto coinvolgimento del sistema nervoso centrale- qualsiasi patologia seria pregressa che a giudizio dell’investigatore, possa compromettere la possibilità del paziente di partecipare allo studio (per es. Malattia autoimmune in fase attiva, diabete scompensato)- diagnosi di tumore nei precedenti 5 anni ad eccezione al tumore alla cervice in situ trattato in modo adeguato oppure tumore cutaneo localizzato ad esclusione del melanoma - Disordini psichiatrici che precludano la comprensione delle informazioni relative allo studio, che precludano il fornire un consenso informato, o che interferiscano con la capacità di assumere dei medicamenti per via orale- ipersensitività conosciuta alla sostanza attiva contenuta nel farmaco (i) o ipersensitività a qualsiasi componente del medicamento in studio- tutti I medicamenti assunti in concomitanza con il medicamento dello studio e controindicati come descritto nel foglio informativo al paziente approvato per il medicamento- Trattamento concomitante con altri medicamenti sperimentali o altri medicamenti anti-tumorali, partecipazione a uno studio clinico nei 30 giorni precedenti all’arruolamento nello studio clinico- Nota infezione da HIV o HCV - pazienti con una chiara presenza serologica di una epatite B attiva o pregressa,ad eccezione di pazienti i cui esami sierologici per epatite possano essere ricondotti a una vaccinazione- pazienti che abbiano assunto regolarmente corticosteroidi durante le 4 settimane precedenti allo studio, se non somministrati a una dose equivalente a prednisone ≤ 15 mg/giorno per indicazioni diverse rispetto al linfoma o per sintomi relati al linfoma- Donne in gravidanza o in allattamento- Pazienti che necessitano di una terapia chemioterapica urgente, per es. per una sindrome da compressione attuale o imminente
    E.5 End points
    E.5.1Primary end point(s)
    Complete response assessed at week 23 (+/- 1 week)
    Risposta completa valutata a 23 settimane +/- 1 settimana
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 23 (+/- 1 week)
    settimana 23 (+/- 1 settimana)
    E.5.2Secondary end point(s)
    Best overall response (OR) within 24 weeks Best OR within 12 weeks Best OR Progression-free survival (PFS) Duration of CR Time to first off-trial anti-lymphoma therapy Overall survival (OS) Adverse events (AEs) including laboratory abnormality assessments and vital signs
    Miglior risposta globale (OR) entro 24 settimane. Miglior OR entro 12 settimane. Miglior sopravvivenza globale libera da progressione (PFS). Durata della remissione completa (CR) Tempo della prima terapia anti-linfoma al di fuori di questo studio Sopravvivenza globale (OS) Eventi avversi (AEs) incluse alterazioni di valori laboratoristici e dei segni vitali
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 months after randomisation
    30 mesi dopo randomizzazione
    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 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
    combinazione vs terapia standard
    combination of 2 medecines vs standrad treatment
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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 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
    All patients will be followed up for at least 10 years after randomization. Afterwards, in the following 10 years, information on survival, disease status and further treatment may be collected upon request of SAKK without scheduled trial visits.
    I pazienti saranno seguiti per almeno 10 anni dopo randomizzazione.Nei seguenti 10 anni,informazioni sulla sopravvivenza,stato della malattia e successivi trattamenti potranno essere raccolte su richiesta della SAKK senza visite visite pianificate.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    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 years10
    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.1.1Number 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: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 152
    F.4.2.2In the whole clinical trial 152
    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)
    Follow-up visits up to 10 years.
    Visite di follow-up fino a 10 anni
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Nordic Lymphoma Group
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-01-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-05-26
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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