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    Summary
    EudraCT Number:2010-019248-37
    Sponsor's Protocol Code Number:IILINFL09
    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:2012-03-20
    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 number2010-019248-37
    A.3Full title of the trial
    A Phase II study of Bendamustine in Combination With Rituximab as Initial Treatment for Patients With Indolent non-follicular Non-Hodgkin’s Lymphoma
    Studio di fase II con Ribomustin in combinazione con Rituximab in pazienti affetti da linfoma non Hodgkin indolente non follicolare in prima linea
    A.4.1Sponsor's protocol code numberIILINFL09
    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 SponsorFONDAZIONE ITALIANA LINFOMI ONLUS
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Ribomustin
    D.2.1.1.2Name of the Marketing Authorisation holderMundipharma GmBH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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.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 MABTHERA*EV 2F 10ML 100MG
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE SpA
    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 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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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
    Patients with advanced untreated Indolent non Follicular non-Hodgkin Lymphomas
    Pazienti con Linfoma non Hodgkin Indolente non Follicolare non precedentemente trattati.
    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 PT
    E.1.2Classification code 10065856
    E.1.2Term Non-Hodgkin's lymphoma unspecified histology indolent
    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 evaluate the overall response rate (CR+PR) obtained with Bendamustine in combination with Rituximab in previously untreated INFL.
    Valutare il tasso di risposta globale (RC+RP)
    E.2.2Secondary objectives of the trial
    • To evaluate the safety of Bendamustine in combination with Rituximab in previous untreated INFL • To evaluate the overall survival (OS) • To evaluate the progression-free survival (PFS) • To evaluate the disease –free survival (DFS)
    • Valutare il profilo di tossicita' • Valutare la sopravvivenza globale (OS) • Valutare la sopravvivenza libera da progressione (PFS) • Valutare la sopravvivenza libera da malattia (DFS)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Understand and voluntarily sign an informed consent form 2) Histological (bone marrow or lymph nodes biopsy) proven diagnosis of B-cell CD20- positive non-follicular NHL according to REAL/WHO Classification: i. small lymphocytic lymphoma-SLL (bone marrow or lymph nodes biopsy) ii. lymphoplasmacytic/citoid lymphoma/ Waldenstrom macroglobulinemia (bone marrow or lymph nodes biopsy) iii. nodal marginal zone lymphoma (lymph nodes biopsy) 3) Untreated patients 4) Stage III or IV or stage II with more than three involved sites 5) Presence of at least one of the following criteria for the definition of active disease a. Systemic symptoms b. Hemoglobin less than 10 g/dL (due to lymphoma) c. Platelets less than 100 x 109/L (due to lymphoma) d. Diffuse bone marrow infiltrate e. Lymphocyte doubling time less than 12 months (in leukemic cases) f. Bulky disease (>7 cm) 6) Aged 18 - 75 Life expectancy >6 months 7) ECOG performance status 0-2 8) LVEF ≥45% or FS ≥37% 9) ANC ≥1 x 109/l and Platelets count ≥75 x 109/l, unless due to bone marrow involvement by follicular lymphoma 10) Creatinine up to 1.5 x ULN 11) Conjugated bilirubin up to 2 x ULN 12) Alkaline phosphatase and transaminases up to 2 x ULN 13) Written informed content
    1) Comprensione e firma volontaria del consenso informato 2) Esame istologico (midollo osseso o biopsia linfonodale) comprovante la diagnosi di linfoma NHL indolente non follicolare B-cell CD20 positivo sulla base della classificazione REAL/WHO: i. linfoma a piccole cellule – SLL (biopsia del midollo osseo o dei linfonodi) ii. lymphoplasmacytic/citoid lymphoma/ Waldenstrom macroglobulinemia (biopsia del midollo osseo o dei linfonodi) iii. linfoma della zona marginale nodale (bipsia dei linfonodi) 3) Pazienti non trattati 4) Stadio III o IV o stadio II con piu' di tre siti coinvolti 5) Presenza di almeno uno dei seguenti criteri per la definizione di malattia attiva: a. Sintomi sistemici b. Emoglobina inferiore a 10 g/dL (a causa del linfoma) c. Piastrine inferiori a 100 x 109/L (a causa del linfoma) d. Midollo osseo infiltrato diffuso e. Tempo di raddoppiamento dei linfociti inferiore a 12 mesi (in casi leucemici) f. Malattia bulky (&gt;7 cm) 6) Eta' compresa tra 18 e 75 anni Aspettativa di vita &gt; 6 mesi 7) ECOG performance status 0-2 8) LVEF ≥45% o FS ≥37% 9) ANC ≥1 x 109/l e conta piastrinica ≥75 x 109/l, tranne in caso di coinvolgimento del midollo osseo da linfoma follicolare 10) Creatinina fino a 1.5 x ULN 11) Bilirubina coniugata fino a 2 x ULN 12) Fosfatasi alcalina e transaminasi fino a 2 x ULN 13) Consenso informato scritto
    E.4Principal exclusion criteria
    1. Patients with diagnosis of marginal zone lymphoma of splenic or MALT origin 2. Patients with diagnosis of typical Chronic Lymphocytic Leukemia (CLL) 3. Men not agreeing to take adequate contraceptive precautions during and for at least 6 months after cessation of therapy 4. History of other malignancies within 3 years prior to study entry except for: adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage, localized prostate cancer treated surgically with curative intent; good prognosis DCIS of the breast treated with lumpectomy alone with curative intent 5. Medical condition requiring long term use (>1 months) of systemic corticosteroids 6. Active bacterial, viral, or fungal infection requiring systemic therapy 7. Concurrent medical condition which might exclude administration of therapy 8. Cardiac insufficiency (NYHA grade III/IV) 9. Myocardial infarction within 6 months of entry on study 10. Severe chronic obstructive pulmonary disease with hypoxemia 11. Severe diabetes mellitus difficult to control with adequate insulin therapy 12. Hypertension that is difficult to control 13. Impaired renal function with creatinine clearance <30 ml/min 14. HIV positivity 15. HBV positivity with the exception of patients HbsAg negative and Ab anti-Hbcore positive (these patientes need to receive prophylaxis with Lamivudine) 16. HCV positivity with the exception of patients with HCV RNA negative. 17. CNS involvement by lymphoma 18. Participation at the same time in another study in with investiogational drugs are used 19. Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins 20. Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent 21. Women in pregnancy or breastfeeding
    1. Pazienti con diagnosi di linfoma della zona marginale di origine splenica o MALT 2. Pazienti con diagnosi di leucemia linfocitica cronica tipica (LLC) 3. Uomini che non accettano di adottare adeguate misure contraccettive durante la terapia e per almeno 6 mesi dopo la sospensione della terapia 4. Storia di altri tumori maligni nei 3 anni precedenti all'entrata nello studio ad eccezione di: carcinoma trattato adeguatamente in situ della cervice uterina, del cancro della pelle basale o cellule squamose, di basso grado, stadio precoce, il cancro alla prostata localizzato trattati chirurgicamente con intento curativo; carcinoma duttale in situ buona prognosi del mammella trattati con lumpectomy sola con intento curativo 5. Patologie che richiedono l'uso a lungo termine (&gt; 1 mese) di corticosteroidi per via sistemica 6. Infezioni batteriche, virali o fungine attive che necessitano di terapia sistemica 7. Concomitante condizione medica che possa escludere la somministrazione della terapia 8. Insufficienza Cardiaca (NYHA grado III/IV) 9. Infarto miocardico nei 6 mesi precedenti all'entrata nello studio 10. Grave malattia polmonare ostruttiva cronica con ipossiemia 11. Diabete mellito grave di difficile controllo con la terapia insulinica adeguata 12. Ipertensione difficile da controllare 13. Compromissione della funzione renale con clearance della creatinina &lt;30 ml / min 14. HIV positivita' 15. HBV positivita' con l'eccezione dei pazienti HBsAg negativi e anti-Ab Hbcore positiva (questi pazienti necessitano di ricevere la profilassi con lamivudina) 16. HCV positivita' con l'eccezione dei pazienti con HCV RNA negativo.. 17. Coinvolgimento del SNC da parte del linfoma 18. Partecipazione concomitante a un altro studio in cui vengono utilizzati farmaci sperimentali 19. Nota ipersensibilita' o reazioni anafilattiche a anticorpi murini o proteine 20. Eventuali altre coesistenti condizioni fisiche o psicologiche che precludano la partecipazione del paziente allo studio o che ne compromettano la capacita' di fornire un consenso informato 21. Donne in gravidanza o allattamento
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate and complete remission rate
    Tasso di risposta globale e tasso di remissione completa
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned29
    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
    La sperimentazione si concludera' dopo l'ultima visita di follow up dell'ultimo paziente arruolato nello studio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    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.1.3Elderly (>=65 years) Yes
    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 state67
    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 Decision2010-12-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-19
    P. End of Trial
    P.End of Trial StatusCompleted
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