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    Summary
    EudraCT Number:2021-000311-23
    Sponsor's Protocol Code Number:PS-CLL-008
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-06-08
    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 number2021-000311-23
    A.3Full title of the trial
    Fixed-duration therapy with ibrutinib and obinutuzumab (GA-101) in treatment-naïve patients with CLL
    Terapia a durata fissa con ibrutinib e obinutuzumab (GA-101) in pazienti con leucemia linfatica cronica (CLL) naïve al trattamento
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ibrutinib and Obinutuzumab as first-line treatment for patients with Chronic Lymphocytic Leukemia
    Ibrutinib e Obinutuzumab come trattamento di prima linea per pazienti affetti dalla Leucemia Linfatica Cronica
    A.3.2Name or abbreviated title of the trial where available
    FIGHT
    FIGHT
    A.4.1Sponsor's protocol code numberPS-CLL-008
    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 SponsorOSPEDALE SAN RAFFAELE
    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 supportJanssen-Cilag International N.V., Belgium
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOspedale San Raffaele
    B.5.2Functional name of contact pointUfficio Data Management PS-CLL
    B.5.3 Address:
    B.5.3.1Street Addressvia Olgettina 60
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20132
    B.5.3.4CountryItaly
    B.5.4Telephone number00390226433919
    B.5.5Fax number00390226432611
    B.5.6E-mailghia.paolo@hsr.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 imbruvica
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN-CILANG INTERNATIONAL NV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNA
    D.3.2Product code [NA]
    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.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB120863
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 gazyvaro
    D.2.1.1.2Name of the Marketing Authorisation holderroche registration gmbh
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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/3/12/1054
    D.3 Description of the IMP
    D.3.1Product nameGazyvaro
    D.3.2Product code [Gazyvaro]
    D.3.4Pharmaceutical form Concentrate for solution for injection
    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 INNobinutuzumab
    D.3.9.1CAS number 949142-50-1
    D.3.9.2Current sponsor codeobinutuzumab
    D.3.9.4EV Substance CodeSUB32751
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeanticorpo monoclonale (mAb) umanizzato e glico-ingegnerizzato
    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
    chronic lymphocytic leukemia/small lymphocytic lymphoma
    Leucemia Linfatica Cronica/ Linfoma linfocitico a piccole cellule
    E.1.1.1Medical condition in easily understood language
    chronic lymphocytic leukemia/small lymphocytic lymphoma
    Leucemia Linfatica Cronica/ Linfoma linfocitico a piccole cellule
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10008976
    E.1.2Term Chronic lymphocytic leukemia
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the percentage of BM MRD <10-4 in BM at +30 days of follow-up after ibrutinib (Cycles 1-24) and obinutuzumab (Cycle 13 Days 1,2,8,15; Cycles 14-18 Day 1)
    Valutare la percentuale di BM MRD <10-4 nel BM a +30 giorni di follow-up dopo ibrutinib (Cicli 1-24) e obinutuzumab (Ciclo 13 Giorni 1,2,8,15; Cicli 14-18 Giorno 1)
    E.2.2Secondary objectives of the trial
    ¿ To evaluate the response to treatment after ibrutinib (Cycles 1-24) and obinutuzumab (Cycle 13 Days 1,2,8,15; Cycles 14-18 Day 1);
    ¿ Evaluate PFS after ibrutinib (Cycles 1-24) and obinutuzumab (Cycle 13 Days 1,2,8,15; Cycles 14-18 Day 1);
    ¿ To evaluate OS after ibrutinib (Cycles 1-24) and obinutuzumab (Cycle 13 Days 1,2,8,15; Cycles 14-18 Day 1);
    ¿ Evaluate the response to retreatment with ibrutinib monotherapy in patients who experience disease recurrence after discontinuation of treatment;
    ¿ To study the safety and tolerance of the combined treatment with a limited duration (treatment and post-treatment period) and compare the results with historical controls.
    ¿ Valutare la risposta al trattamento dopo ibrutinib (Cicli 1-24) e obinutuzumab (Ciclo 13 Giorni 1,2,8,15; Cicli 14-18 Giorno 1);
    ¿ Valutare la PFS dopo ibrutinib (Cicli 1-24) e obinutuzumab (Ciclo 13 Giorni 1,2,8,15; Cicli 14-18 Giorno 1);
    ¿ Valutare la OS dopo ibrutinib (Cicli 1-24) e obinutuzumab (Ciclo 13 Giorni 1,2,8,15; Cicli 14-18 Giorno 1);
    ¿ Valutare la risposta al ritrattamento con ibrutinib in monoterapia nei pazienti che vanno incontro a recidiva di malattia dopo l’interruzione del trattamento;
    ¿ Studiare la sicurezza e la tolleranza del trattamento combinato a durata limitata (period di trattamento e post-trattamento) e confrontare i risultati con I controlli storici.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age =18 years
    2. Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocyte lymphoma (SLL) according to iwCLL diagnostic criteria
    3. Previously untreated active disease requiring treatment according to iwCLL criteria
    4. ECOG PS 0 or 1
    5. Lymph node disease measurable (longest diameter> 1.5 cm) by CT
    6. Adequate blood count defined as:
    ¿ Absolute neutrophil count (ANC)> 750 cells / µL (750 cells / mm3 or 0.75 x 109 / L)
    ¿ Platelet count> 30,000 / µL (30,000 cells / mm3 or 30 x 109 / L)
    ¿ Hemoglobin> 8.0 g / dL
    7. Adequate liver and kidney function defined as:
    ¿ Serum aspartate transaminase (AST) or alanine transaminase (ALT) =3.0 x upper limit of normal (ULN)
    ¿ Estimated Creatinine Clearance (CrCl) =30 mL / min (Cockcroft-Gault)
    ¿ Bilirubin =1.5 x ULN (unless increased bilirubin is due to Gilbert's syndrome or of non-hepatic origin)
    8. Prothrombin time (PT) / International normal ratio (INR) <1.5 x ULN and PTT (activated partial thromboplastin time [aPTT]) <1.5 x ULN (unless abnormalities are related to coagulopathy or bleeding disorder) .
    1. Età =18 anni
    2. Diagnosi di leucemia linfatica cronica (CLL) o linfoma a piccolo linfociti (SLL) secondo i criteri diagnostici iwCLL
    3. Malattia attiva precedentemente non trattata che richiede un trattamento secondo i criteri iwCLL
    4. ECOG PS 0 o 1
    5. Malattia linfonodale misurabile (diametro più lungo> 1.5 cm) mediante TC
    6. Adeguata crasi ematica definita come:
    ¿ Conta assoluta dei neutrofili (ANC)> 750 cellule / µL (750 cellule / mm3 o 0.75 x 109/L)
    ¿ Conta piastrinica> 30.000/µL (30.000 cellule/mm3 o 30 x 109/L)
    ¿ Emoglobina> 8.0 g / dL
    7. Adeguata funzionalità epatica e renale definita come:
    ¿ Aspartato transaminasi (AST) o alanina transaminasi (ALT) sieriche =3.0 x limite superiore della norma (ULN)
    ¿ Clearance stimata della creatinina (CrCl) =30 mL/ min (Cockcroft-Gault)
    ¿ Bilirubina =1.5 x ULN (a meno che l'aumento della bilirubina non sia dovuto alla sindrome di Gilbert o di origine non epatica)
    8. Tempo di protrombina (PT)/International normal ratio (INR) <1.5 x ULN e PTT (tempo di tromboplastina parziale attivata [aPTT]) <1.5 x ULN (a meno che le anomalie non siano correlate a coagulopatia o disturbo emorragico).
    E.4Principal exclusion criteria
    1. Any prior therapy (including but not limited to chemotherapy, targeted therapy, immunomodulatory therapy, radiotherapy, and / or monoclonal antibody) used to treat CLL or SLL.
    2. Patients with del (17p) and / or TP53 mutation according to centralized laboratory assessment.
    3. History of other malignancies, except:
    ¿ Malignant tumor treated with curative intent and with no known active disease present for =3 prior to first dose of study drug and deemed low risk of recurrence by treating physician
    ¿ Malignant skin neoplasm not adequately treated or lentigo maligna with no evidence of disease
    ¿ Adequately treated carcinoma in situ with no evidence of disease.
    4. Known or suspected history of Richter's transformation.
    5. Known hypersensitivity to one or more study drugs.
    6. Known bleeding disorders (eg von Willebrand disease or haemophilia).
    7. History of stroke or intracranial haemorrhage within 6 months prior to enrollment.
    8. Known history of human immunodeficiency virus (HIV) or active hepatitis C virus (HCV) or hepatitis B virus (HBV) infection. Individuals who are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) result before enrollment. Those who test positive for PCR will be excluded.
    9. Inability to swallow capsules / tablets or malabsorption syndrome, any disease that significantly affects gastrointestinal function, or resection of the stomach or small intestine, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction.
    10. Concomitant use of warfarin or other vitamin K antagonists.
    11. Major surgery within 4 weeks of the first dose of study drug
    1. Qualsiasi terapia precedente (inclusa ma non limitata a chemioterapia, terapia mirata, terapia immunomodulante, radioterapia e/o anticorpo monoclonale) utilizzata per il trattamento di CLL o SLL.
    2. Pazienti portatori di del (17p) e/o mutazione di TP53 in base alla valutazione del laboratorio centralizzato.
    3. Storia di altre neoplasie, eccetto:
    ¿ Tumore maligno trattato con intento curativo e senza malattia attiva nota presente per =3 prima della prima dose del farmaco in studio e ritenuta a basso rischio di recidiva dal medico curante
    ¿ Tumore maligno della pelle non melanoma adeguatamente trattato o lentigo maligna senza evidenza di malattia
    ¿ Carcinoma in situ adeguatamente trattato senza evidenza di malattia.
    4. Storia nota o sospetta di trasformazione di Richter.
    5. Ipersensibilità nota a uno o più farmaci in studio.
    6. Disturbi emorragici noti (ad esempio, malattia di von Willebrand o emofilia).
    7. Storia di ictus o emorragia intracranica nei 6 mesi precedenti l'arruolamento.
    8. Anamnesi nota di virus dell'immunodeficienza umana (HIV) o infezione attiva da virus dell'epatite C (HCV) o virus dell'epatite B (HBV). I soggetti che sono positivi per l'anticorpo core dell'epatite B, l'antigene di superficie dell'epatite B (HBsAg) o l'anticorpo dell'epatite C devono avere un risultato negativo della reazione a catena della polimerasi (PCR) prima dell'arruolamento. Saranno esclusi coloro che risultano positivi alla PCR.
    9. Incapacità di deglutire capsule/compresse o sindrome da malassorbimento, qualsiasi malattia che influisce in modo significativo sulla funzione gastrointestinale, o resezione dello stomaco o dell'intestino tenue, malattia infiammatoria intestinale sintomatica o colite ulcerosa, o ostruzione intestinale parziale o completa.
    10. Uso concomitante di warfarin o altri antagonisti della vitamina K.
    11. Intervento chirurgico maggiore entro 4 settimane dalla prima dose del farmaco in studio
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients with MRD <10-4 in BM at +30 follow-up days after completion of therapy
    Percentuale di pazienti con MRD<10-4 nel BM a +30 giorni follow-up dopo il completamento della terapia
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days after completion of therapy
    30 giorni dopo completamento della terapia
    E.5.2Secondary end point(s)
    Safety and tolerance; Overall response (partial response, partial response with lymphocytosis and complete response); Percentage of MRD undetectable at Cycle 13 Day 1 (before the start of obinutuzumab), Cycle 19 Day 1 (at the end of treatment with obinutuzumab); Percentage of complete responses; Progression-free survival; Overall survival; Overall response rate to Ibrutinib retreatment to relapse
    Sicurezza e tolleranza; Risposta complessiva (risposta parziale, risposta parziale con linfocitosi e risposta completa); Percentuale di MRD non rilevabile al Ciclo 13 Giorno 1 (prima dell’inizio di obinutuzumab), al Ciclo 19 Giorno 1 (al termine del trattamento con obinutuzumab); Percentuale di risposte complete; Sopravvivenza libera da progressione; Sopravvivenza globale; Percentuale di risposta complessiva al ritrattamento con ibrutinib alla ricaduta
    E.5.2.1Timepoint(s) of evaluation of this end point
    during treatment and follow up period; during treatment and follow up period; during treatment; during treatment period and follow up period; duirng follow up period; during treatment period and follow up period; during follow up period
    durante il trattamento e nel follow up; durante il trattamento e nel periodo di follow up; durante il trattamento; durante il periodo di trattamento e durante il periodo di follow up; durante il periodo di follow up; Durante il trattamento e durante il periodo di follow up; durante il periodo di follow up
    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 No
    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 No
    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 concerned12
    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 Information not present in EudraCT
    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 years6
    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 years6
    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.1.1.1In 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: 13
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state53
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 53
    F.4.2.2In the whole clinical trial 53
    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)
    NOT APPLICABLE
    NON APPLICABILE
    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 Decision2021-06-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-10
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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