Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43925   clinical trials with a EudraCT protocol, of which   7306   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2012-000694-23
    Sponsor's Protocol Code Number:PCYC-1112-CA
    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:2012-06-15
    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 number2012-000694-23
    A.3Full title of the trial
    A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton’s Tyrosine Kinase (BTK) Inhibitor Ibrutinib versus Ofatumumab in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
    Studio di fase 3 in aperto, randomizzato e multicentro su ibrutinib rispetto a ofatumumab come inibitori della tirosina-chinasi di Bruton (BTK) in pazienti affetti da leucemia linfocitica cronica (CLL)/linfoma linfocitico a piccole cellule (SLL) recidivi o refrattari
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton’s Tyrosine Kinase (BTK) Inhibitor Ibrutinib versus Ofatumumab in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
    Studio di fase 3 in aperto, randomizzato e multicentro su ibrutinib rispetto a ofatumumab come inibitori della tirosina-chinasi di Bruton (BTK) in pazienti affetti da leucemia linfocitica cronica (CLL)/linfoma linfocitico a piccole cellule (SLL) recidivi o refrattari
    A.3.2Name or abbreviated title of the trial where available
    PCYC-1112-CA
    PCYC-1112-CA
    A.4.1Sponsor's protocol code numberPCYC-1112-CA
    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 SponsorPHARMACYCLICS 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 supportPharmacyclics, Incorporated
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharmacyclics Incorporated
    B.5.2Functional name of contact pointnd
    B.5.3 Address:
    B.5.3.1Street Address995 East Arquest Avenue
    B.5.3.2Town/ citySunnyvale, CA
    B.5.3.3Post code94085-4521
    B.5.3.4CountryUnited States
    B.5.4Telephone number001 408 215 3305
    B.5.5Fax number001 405 215 3684
    B.5.6E-mailjwest@pcyc.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 Yes
    D.2.5.1Orphan drug designation numberEMA/OD/156/11
    D.3 Description of the IMP
    D.3.1Product nameIbrutinib
    D.3.2Product code PCI-32765
    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 INNIbrutinib
    D.3.9.1CAS number 936563-96-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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 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 ARZERRA*EV 1FL 1000MG 50MG
    D.2.1.1.2Name of the Marketing Authorisation holderGLAXOSMITHKLINE 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 Yes
    D.2.5.1Orphan drug designation numberEU/3/08/581
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Concentrate for solution for injection/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.3.9.1CAS number 679818-59-8
    D.3.9.3Other descriptive nameofatumumab
    D.3.9.4EV Substance CodeSUB25221
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 679818-59-8
    D.3.9.3Other descriptive nameofatumumab
    D.3.9.4EV Substance CodeSUB25221
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 Yes
    D.3.11.13.1Other medicinal product typetIpO I anti-CD20 anticorpo monoclonale completamente umanizzato
    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 CLL/SLL
    leucemia linfocitica cronica (CLL)/linfoma linfocitico a piccole cellule (SLL) recidivi o refrattari
    E.1.1.1Medical condition in easily understood language
    relapsed or refractory CLL/SLL
    leucemia linfocitica cronica (CLL)/linfoma linfocitico a piccole cellule (SLL) recidivi o refrattari
    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 10060671
    E.1.2Term B-cell chronic lymphocytic leukemia/prolymphocytic leukemia/small lymphocytic lymphoma refractory
    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 efficacy of ibrutinib compared to ofatumumab based on the independent review committee (IRC) of PFS in patients with relapsed or refractory CLL/SLL
    Valutare l'efficacia di ibrutinib rispetto a ofatumumab in termini di sopravvivenza senza progressione stabilita da un comitato di revisione indipendente (IRC) secondo i criteri International Workshop on Chronic Lymphocytic Leukemia Criteria (IWCLL, Hallek 2008) (di seguito citati come criteri IWCLL 2008) in pazienti con CLL/SLL recidivi o refrattari
    E.2.2Secondary objectives of the trial
    To compare between the two treatment groups in terms of: Efficacy • To evaluate Investigator-assessed PFS per IWCLL 2008 criteria • To determine IRC-assessed ORR per IWCLL2008 criteria • To evaluate Investigator-assessed ORR per IWCLL 2008 criteria • To evaluate OS • To evaluate hematological improvement • To evaluate improvement and/or resolution of disease-related symptoms Safety • To evaluate the safety and tolerability of ibrutinib compared to of Ofatumumab
    Confrontare l'efficacia tra i due gruppi di trattamento in termini di:
    • valutazione della sopravvivenza senza progressione valutata dallo sperimentatore secondo i criteri IWCLL 2008;
    • determinazione del tasso di risposta globale valutato dall'ICR secondo i criteri IWCLL 2008;
    • determinazione del tasso di risposta globale valutato dallo sperimentatore secondo i criteri IWCLL 2008;
    • valutazione della sopravvivenza globale;
    • valutazione del miglioramento ematologico;
    • valutazione del miglioramento e/o risoluzione dei sintomi correlati alla malattia.
    Sicurezza
    • Valutare la sicurezza e la tollerabilità di ibrutinib rispetto a ofatumumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women ≥ 18 years of age 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 3. Life expectancy of > 4 months from the 1st dose of study medication 4. Diagnosis of CLL/SLL that meets published diagnostic criteria (Hallek 2008): a) Monoclonal B-cells (either kappa or lambda light chain restricted) that are clonally co expressing at least one B-cell marker (CD19, CD20, or CD23) and CD5, b) The diagnosis of CLL requires a history of lymphocytosis with a B-lymphocyte count ≥5,000/µl while SLL patients are characterized by the same criteria with a circulating B lymphocyte count <5,000/µl. Prolymphocytes may comprise no more than 55% of blood lymphocytes 5. Active disease meeting at least 1 of the following IWCLL 2008 criteria for requiring treatment: a) Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia (Hgb < 11 g/dL) and/or thrombocytopenia (platelets < 100,000/L), b) Massive, progressive, or symptomatic splenomegaly, c) Massive nodes, progressive, or symptomatic lymphadenopathy, d) Progressive lymphocytosis with an increase of > 50% over a 2-month period or a lymphocyte doubling time (LDT) of < 6 months. LDT may be obtained by linear regression extrapolation of absolute lymphocyte counts (ALC) obtained at intervals of 2 weeks over an observation period of 2 to 3 months. In patients with initial blood lymphocyte counts of < 30 X 109/L (30,000/μL), LDT should not be used as a single parameter to define indication for treatment. In addition, factors contributing to lymphocytosis or lymphadenopathy other than CLL should be excluded, e) Autoimmune anemia and/or thrombocytopenia that is poorly responsive to corticosteroids or other standard therapy, f) Constitutional symptoms, defined as one or more of the following disease-related symptoms or signs, i) Unintentional weight loss > 10% within the previous 6 months prior to Screening ii) Significant fatigue; iii) Fevers higher than 100.5° F or 38 .0° C for 2 or more weeks prior to Screening without evidence of infection or iv) Night sweats for more than 1 month prior to Screening without evidence of infection 6. Must have received at least one prior therapy for CLL/SLL and not be appropriate for treatment or retreatment with purine analog based therapy, defined by at least one of the following criteria: a) Failure to respond (stable disease [SD] or disease progression on treatment), or a progression-free interval of less than 3 years from treatment with a purine analog based therapy and anti-CD20 containing chemoimmunotherapy regimen after at least two cycles, b) Age ≥ 70 years, or age ≥ 65 and the presence of co-morbidities (Cumulative Illness Rating Scale [CIRS] ≥ 6 or CrCl < 70 mL/min) that might place the patient at an unacceptable risk for treatment-related toxicity with purine analog based therapy, provided they have received >1 prior treatment including at least two cycles of an alkylating-agent based (or purine analog based) anti-CD20 antibody containing chemoimmunotherapy regimen. CIRS score can be determined utilizing a web-based tool. c) History of purine analog-associated autoimmune anemia or autoimmune thrombocytopenia, d) FISH showing 17p del in ≥ 20% of cells (either at diagnosis or any time before study entry) either alone or in combination with other cytogenetic abnormalities, provided they have received at least one prior therapy 7. Measurable nodal disease by CT. 8. Meet the following laboratory parameters: a) Absolute neutrophil count (ANC) ≥ 750 cells/μL (0.75 x 109/L), independent of growth factor support within 7 days of the first dose with study drug, b) Platelet count ≥ 30,000 cells/μL (30 x 109/L) without transfusion support within 7 days of the first dose with study drug. Patients with transfusion-dependent thrombocytopenia are excluded, c) Serum aspartate transaminase (AST) or alanin
    • Stato di validità dell'ECOG (Eastern Cooperative Oncology Group) di 0-1
    • Aspettativa di vita superiore a 4 mesi
    • Diagnosi di CLL o SLL che soddisfa i criteri IWCLL 2008
    • Malattia attiva che soddisfa almeno uno dei criteri IWCLL 2008 per la necessità di trattamento
    • I pazienti devono aver ricevuto almeno una precedente terapia per CLL/SLL
    • I pazienti non devono essere idonei al trattamento o alla ripetizione del trattamento con terapia basata sugli analoghi delle purine
    • Malattia nodale misurabile mediante TAC
    • Per l'inclusione, i pazienti devono soddisfare i seguenti parametri di laboratorio:
     Conta assoluta dei neutrofili (ANC) 750 cellule/μL (senza assumere fattori di crescita)
     Conta piastrinica 30.000 cellule/μL (30 x 109/L) senza trasfusione
     Aspartato transaminasi (AST/SGOT) o alanina transaminasi (ALT/SGPT) nel siero &lt; 2,5 volte rispetto al limite superiore dell’intervallo normale di riferimento
     Bilirubina totale ≤ 1,5 volte rispetto al limite superiore dell’intervallo normale di riferimento
     Creatinina ≤ 2 volte rispetto a limite superiore dell’intervallo normale di riferimento e velocità di filtrazione glomerulare (GFR [Cockcroft-Gault]) stimata ≥ 30 mL/min.
    • I pazienti devono potersi sottoporre al trattamento in regime ambulatoriale e al monitoraggio di laboratorio presso l'istituto che somministra il farmaco sperimentale per l'intera durata dello studio
    E.4Principal exclusion criteria
    Patients will be ineligible for this study if they meet any of the following criteria: 1. Known central nervous system (CNS) lymphoma or leukemia 2. Any history of Richter’s transformation or prolymphocytic leukemia 3. No documentation of cytogenetic and/or FISH results reflecting 17p del status in records prior to first dose of study drug 4. Uncontrolled Autoimmune Hemolytic Anemia (AIHA) or ideopathic thrombocytopenia purpura (ITP), such as those patients with a declining hemoglobin (Hgb) level or platelet count secondary to autoimmune destruction within the 4 weeks prior to first dose of study drug or the need for daily corticosteroids >20 mg daily 5. Prior exposure to ofatumumab or to ibrutinib 6. Previous randomization in a PCI-32765/ibrutinib study 7. Received any chemotherapy, external beam radiation therapy, anticancer antibodies, or investigational drug within 30 days prior to first dose of study drug 8. Corticosteroid use within 1 week prior to first dose of study drug, except as indicated for other medical conditions such as inhaled steroid for asthma, topical steroid use, or as premedication for administration of study drug or contrast. Patients requiring steroids at daily doses > 20 mg prednisone equivalent systemic exposure daily, or those who are administered steroids for leukemia control or white blood cell count lowering are excluded 9. Radio- or toxin-conjugated antibody therapy within 10 weeks prior to first dose of study drug 10. Prior autologous transplant within 6 months prior to first dose of study drug 11. Prior allogeneic stem cell transplant within 6 months prior to first dose of study drug 12. Major surgery within 4 weeks prior to first dose of study drug 13. History of prior malignancy, with the exception of the following: a) Malignancy treated with curative intent and with no evidence of active disease present for more than 3 years prior to Screening and felt to be at low risk for recurrence by treating physician b) Adequately treated non-melanomatous skin cancer or lentigo maligna melanoma without current evidence of disease c) Adequately treated cervical carcinoma in situ without current evidence of disease 14. Currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or history of myocardial infarction within 6 months prior to first dose with study drug 15. Unable to swallow capsules or disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption such as; malabsorption syndrome, resection of the small bowel, or poorly controlled inflammatory bowel disease affecting the small intestine 16. Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment) 17. Known history of infection with human immunodeficiency virus (HIV) 18. Serologic status reflecting active hepatitis B or C infection. Patients with hepatitis B core antibody positive who are antigen negative will need to have a negative polymerase chain reaction (PCR) result prior to enrollment. Those who are hepatitis B antigen positive or PCR positive will be excluded 19. History of stroke or intracranial hemorrhage within 6 months prior to enrollment 20. Pregnant or lactating women 21. Current life-threatening illness, medical condition, or organ system dysfunction 22. Requires anticoagulation with warfarin 23. Requires treatment with a strong CYP3A4/5 and/or CYP2D6 inhibitor
    • Linfoma del sistema nervoso centrale o leucemia noti
    • Anamnesi di trasformazione di Richter o leucemia prolinfocitica
    • Nessuna documentazione di risultati citogenetici e/o FISH che riflettano lo stato 17p del nei dati del paziente prima della dose iniziale del farmaco sperimentale
    • Anemia emolitica autoimmune non controllata (AIHA) o porpora trombocitopenica idiopatica (ITP)
    • Precedente esposizione a ofatumumab o a ibrutinib
    • Il paziente si è sottoposto a chemioterapia o a radioterapia con fascio esterno, ha assunto anticorpi anticancro o un farmaco sperimentale entro 30 giorni prima della dose iniziale del farmaco sperimentale
    • Utilizzo di corticosteroidi &gt; 20 mg entro una settimana prima della dose iniziale del farmaco sperimentale
    • Utilizzo di terapia anticorpale associata a radioterapia o assunzione di tossine entro 10 giorni prima della dose iniziale del farmaco sperimentale
    • Precedente trapianto autologo entro sei mesi prima della dose iniziale del farmaco sperimentale
    • Precedente trapianto allogenico di cellule staminali entro sei mesi prima della dose iniziale del farmaco sperimentale
    • Intervento chirurgico importante entro quattro settimane prima della dose iniziale del farmaco sperimentale
    • Anamnesi di neoplasia pregressa, ad eccezione di determinati cancri e neoplasie della cute trattati con intento curativo e con nessuna evidenza di malattia attiva da più di tre anni
    • Malattia cardiovascolare significativa dal punto di vista clinico e attualmente attiva o anamnesi di infarto miocardico entro sei mesi prima della dose iniziale del farmaco sperimentale
    • Anamnesi nota di infezione da virus dell'immunodeficienza umana (HIV)
    • Stato sierologico che riflette infezione da epatite B o C attiva
    • Incapacità di ingoiare capsule o malattia che compromette significativamente la funzione gastrointestinale
    • Infezione micotica, batterica, virale o di altra natura sistemica attiva non controllata
    • Anamnesi di ictus o emorragia intracranica entro sei mesi prima della dose iniziale del farmaco sperimentale
    • Necessità di anticoagulazione con warfarin
    • Necessità di trattamento con un forte inibitore del CYP 3A4/5 e/o del CYP2D6
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is PFS, as assessed by IRC review per IWCLL 2008 criteria
    L'endpoint primario di questo studio è la sopravvivenza senza progressione della malattia, in base alla valutazione da parte dell'IRC secondo i criteri IWCLL 2008
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months
    24 mesi
    E.5.2Secondary end point(s)
    secondary endpoints are : Efficacy To compare between the two treatment groups in terms of: • Investigator-assessed PFS per IWCLL 2008 criteria. • Overall response rate (ORR) is defined as the proportion of patients who achieve complete response (CR), complete response with incomplete bone marrow recovery (CRi), nodular partial response (nPR), or partial response (PR) per IWCLL 2008 criteria over the course of the study as evaluated by an IRC • Investigator-assessed ORR per IWCLL 2008 criteria • OS • Hematological improvement in the subset of patients with cytopenia(s) at baseline assessed by time to improvement and percentage of patients with improvement • Improvement of disease-related symptoms (fatigue, night sweats, and splenomegaly) Safety • To compare the safety and tolerability between the two treatment
    Efficacia
    Confrontare l'efficacia tra i due gruppi di trattamento in termini di:
    • sopravvivenza senza progressione valutata dallo sperimentatore secondo i criteri IWCLL 2008;
    • tasso di risposta globale (ORR) definito come la proporzione di pazienti che raggiungono una risposta (in base alla valutazione da parte dell'IRC secondo i criteri IWCLL 2008)
    • tasso di risposta globale valutato dallo sperimentatore secondo i criteri IWCLL 2008;
    • sopravvivenza globale;
    • miglioramento ematologico nel sottoinsieme di pazienti con citopenia(e) al basale valutata(e) in base alla percentuale di pazienti con un miglioramento nelle conte ematiche e al tempo di raggiungimento di tale miglioramento
    • miglioramento dei sintomi correlati alla malattia (stanchezza, sudorazioni notturne e splenomegalia)
    Sicurezza
    • Confrontare la sicurezza e la tollerabilità tra i due gruppi di trattamento
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 months
    24 mesi
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    tolerability
    tollerabilità
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Ofatumumab
    Ofatumumab
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA47
    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
    Australia
    United States
    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 months40
    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 months40
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 280
    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 state49
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 276
    F.4.2.2In the whole clinical trial 350
    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)
    patients will return to normal standard of care
    I pazienti torneranno allo standard di cura normale
    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 Decision2012-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-14
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA