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    Summary
    EudraCT Number:2019-001381-14
    Sponsor's Protocol Code Number:VS-0145-229
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-21
    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 number2019-001381-14
    A.3Full title of the trial
    A Phase 2, Randomized, Open-label, 2-Arm Study Comparing 2 IntermittentDosing Schedules of Duvelisib in Subjects with Indolent Non-Hodgkin Lymphoma (iNHL)
    Studio di fase 2, randomizzato, in aperto, a 2 bracci, di confronto tra 2 schemi di somministrazione intermittenti di duvelisib in soggetti con linfoma non Hodgkin indolente (LNHi)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Study of Intermittent Dosing Schedules of Duvelisib in Indolent Non-Hodgkin Lymphoma(iNHL)
    Studio di fase 2 di schemi di somministrazione intermittenti di Duvelisib in soggetti con linfoma non Hodgkin indolente (LNHi)
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberVS-0145-229
    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 SponsorVerastem, 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 supportVerastem, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVerastem, Inc.
    B.5.2Functional name of contact pointGloria Patrick
    B.5.3 Address:
    B.5.3.1Street Address117 Kendrick St., Suite 500
    B.5.3.2Town/ cityNeedham, MA
    B.5.3.3Post code02494
    B.5.3.4CountryUnited States
    B.5.4Telephone number000000
    B.5.5Fax number000000
    B.5.6E-mailgpatrick@verastem.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 numberEU/3/13/1157
    D.3 Description of the IMP
    D.3.1Product nameDuvelisib
    D.3.2Product code [IPI-145]
    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 INNDUVELISIB
    D.3.9.1CAS number 1386861-49-9
    D.3.9.2Current sponsor codeIPI-145
    D.3.9.4EV Substance CodeSUB180102
    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 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 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 numberEU/3/13/1157
    D.3 Description of the IMP
    D.3.1Product nameDuvelisib
    D.3.2Product code [IPI-145]
    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 INNDUVELISIB
    D.3.9.1CAS number 1386861-49-9
    D.3.9.2Current sponsor codeIPI-145
    D.3.9.4EV Substance CodeSUB180102
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.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
    Indolent Non-Hodgkin Lymphoma (iNHL)
    Linfoma non-hodgkin indolente (LNHi)
    E.1.1.1Medical condition in easily understood language
    iNHL is a form of cancer that starts in white blood cells called lymphocytes part of body's immune system. This cancer grows and spreads slowly, often without symptoms. Men and women can develop it.
    LNHi è una forma di cancro dei globuli bianchi, o linfociti, che sono parte del sistema immunitario. Esso cresce e si diffonde lentamente, spesso senza alcun sintomo, sia negli uomini che nelle donne.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10029621
    E.1.2Term Non-Hodgkin's lymphomas unspecified histology indolent
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the efficacy of duvelisib administered with prescribed drug holidays in subjects with iNHL (based on Cheson 2007)
    Valutare l’efficacia di duvelisib somministrato con periodi prescritti di sospensione del farmaco in soggetti con LNHi (sulla base del Cheson 2007)
    E.2.2Secondary objectives of the trial
    - Evaluate supportive efficacy measures of duvelisib administered with prescribed drug holidays in subjects with iNHL (Based on Cheeson 2014);
    - Evaluate the safety and tolerability of duvelisib administered with prescribed drug holidays in subjects with iNHL;
    - Characterize the pharmacokinetics (PK) of duvelisib and metabolite IPI-656 when duvelisib isadministered with prescribed drug holidays in subjects with iNHL.

    EXPLORATORY OBJECTIVES :
    - Evaluate Quality of Life (QoL) in subjects with iNHL treated with duvelisib with prescribed drug holidays;
    - Evaluate potential biomarkers of clinical efficacy and/or safety of duvelisib administered with prescribed drug holidays in subjects with iNHL
    - Valutare le misure di efficacia di supporto di duvelisib somministrato con periodi prescritti di sospensione del farmaco in soggetti con LNHi (sulla base di Cheeson 2014);
    - Valutare la sicurezza e la tollerabilità di duvelisib somministrato con periodi prescritti di sospensione del farmaco in soggetti con LNHi;
    -Caratterizzare la farmacocinetica (PK) di duvelisib e del metabolita IPI-656 quando duvelisib è somministrato con periodi prescritti di sospensione del farmaco in soggetti con LNHi.

    OBIETTIVI ESPLORATIVI:
    - Valutare la qualità della vita (QoL) in soggetti con LNHi trattati con duvelisib con periodi prescritti di sospensione del farmaco;
    - Valutare potenziali biomarcatori di efficacia clinica e/o sicurezza di duvelisib somministrato con periodi prescritti di sospensione del farmaco in soggetti con LNHi
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects >= 18 years of age
    2. Histologically confirmed diagnosis of iNHL. Histologic subtypes includeFL Grades 1 to 3a, marginal zone lymphoma (splenic, nodal, or extranodal), or SLL.
    3. Must have received at least 1 prior systemic regimen for iNHL
    4. Must have documented radiologic evidence of disease progression, at least 1 Bidimensionally measurable lesion >= 1.5 cm (which has not been previously irradiated),according to 2007 revised IWG criteria (Cheson 2007) and be a candidate for a subsequent line of therapy
    5. Must have adequate organ function defined by the following laboratory parameters:
    a. Absolute neutrophil count (ANC) >= 1.0 × 109/L
    b. Platelet count >= 75 × 109/L
    c.Hemoglobin = 8 g/dL
    d.Estimated creatinine clearance (eCCr) = 60 mL/min, as determined by the Cockcroft-Gault method (Cockcroft 1976)
    e. Total bilirubin <= 1.5 × upper limit of normal (ULN) (exception: subjects with Gilbert's Syndrome may have a bilirubin > 1.5 × ULN)
    f. Aspartate transaminase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum pyruvic transaminase (SGPT) <= 3.0 × ULN
    6. Eastern Cooperative Oncology Group (ECOG) performance status <= 2
    7. Male and female subjects of reproductive potential (i.e., not surgically sterile or female subjects who are not postmenopausal) must be willing to use highly effective methods of contraception (see Section 10.4) for the duration of the study intervention and for 3 months after the last dose of duvelisib
    8. Negative serum human chorionic gonadotropin (hCG) pregnancy test within 7 days before first dose of study intervention if the subject is a woman of childbearing potential(WCBP) (defined in Section 10.4)
    9. Signed and dated institutional review board (IRB)/independent ethics committee (IEC)-approved informed consent form before any study specific-screening procedures are performed
    1. Soggetti maschi o femmine >= 18 anni di età
    2. Diagnosi di LNHi confermata da analisi istologiche. I sottotipi istologici comprendono: FL di grado da 1 a 3a, linfoma di zona marginale (splenico, nodale o extranodale), o SLL.
    3. Aver ricevuto precedentemente almeno 1 trattamento sistemico per LNHi
    4.Evidenza radiologica e documentata della progressione della malattia, almeno 1 Lesione misurabile bidimensionalmente >= 1,5 cm (non precedentemente irradiata), secondo i criteri IWG 2007 rivisti (Cheson 2007) ed essere un candidato per una successiva linea di terapia.
    5. Adeguata funzione degli organi definita dai seguenti parametri di laboratorio:
    a. Conta dei neutrofili assoluti (ANC) >= 1,0 × 109/L
    b. Conteggio delle piastrine >= 75 × 109/L
    c. Emoglobina = 8 g/dl
    d. Clereance stimata della creatinina (eCCr) = 60 mL / min, come determinato dal metodo Cockcroft-Gault (Cockcroft 1976)
    e. Bilirubina totale <= 1,5 × limite superiore del normale (ULN) (eccezione: i soggetti con la sindrome di Gilbert possono avere una bilirubina > 1,5 × ULN).
    f. Aspartato transaminasi (AST)/siero glutamico-oxaloacetico transaminasi (SGOT) e alanina aminotransferasi (ALT)/siero piruvico transaminasi (SGPT) <= 3,0 × ULN
    6. Stato della performande di Eastern Cooperative Oncology Group (ECOG) <= 2
    7. Soggetti di sesso maschile e femminile fertili (es. non chirurgicamente sterili o soggetti di sesso femminile non in postmenopausa) devono essere disposti ad utilizzare metodi contraccettivi altamente efficaci (vedere paragrafo 10.4) per tutta la durata dello studio e per i 3 mesi successivi all'ultima dose di duvelisib.
    8. Test di gravidanza negativo per la gonadotropina corionica umana (hCG) nei 7 giorni precedenti la prima dose del farmaco sperimentale se il soggetto è una donna con potenziale fertile (WCBP) (definito nella Sezione 10.4).
    9. Consenso informato firmato, datato e approvato dal comitato di revisione istituzionale (IRB)/comitato etico indipendente (IEC)-approvato prima di eseguire qualsiasi procedura di screening specifica per lo studio.
    E.4Principal exclusion criteria
    1. Anticancer treatment, major surgery, or use of any investigational drug within 28 days before the start of study intervention; palliative radiation therapy is allowed if > 7 days before planned first dose of study interventions and any toxicity is Grade <= 1.
    2. Clinical or histological evidence of transformation to a more aggressive subtype of Lymphoma or grade 3b FL or Richter's transformation or CLL
    3. Received prior allogeneic hematopoietic stem cell transplant (HSCT)
    4. Previous treatment with a PI3K inhibitor
    5. Known hypersensitivity to duvelisib and/or its excipients
    6. History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function
    7. Prior history of drug-induced colitis or drug-induced pneumonitis
    8. History of tuberculosis treatment within the 2 years prior to randomization
    9. Administration of a live or live attenuated vaccine within 6 weeks of randomization
    10. Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic steroids > 20 mg of prednisone (or equivalent) per day
    11. Ongoing treatment for systemic bacterial, fungal, or viral infection at screening
    • Note: Subjects on antimicrobial, antifungal, or antiviral prophylaxis arenot specifically excluded if all other inclusion/exclusion criteria are met
    12. Active cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection (i.e., subjects with detectable viral load)
    13. Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV), or herpes zoster (VZV) at screening
    14. Infection with hepatitis B, hepatitis C,or human immunodeficiency virus (HIV)
    • Subjects with a positive hepatitis B surface antigen [HBsAg] or hepatitis C antibody[HCV Ab] will be excluded
    • Subjects with a positive hepatitis B core antibody (HBcAb) must have negative hepatitis B virus (HBV) deoxyribonucleic acid (DNA) to be eligible and must be periodically monitored for HBV reactivation by institutional guidelines
    • Investigators who strongly believe that a positive HBcAb is false due to passive immunization from previous immunoglobulin infusion therapy should discuss the potential to defer HBV prophylaxis with the Medical Monitor
    15. Concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome P450 3A (CYP3A). No prior use within 2 weeks before the start of study intervention.
    16. Subjects with clinically significant medical condition of malabsorption, inflammatory bowel disease, chronic conditions which manifest with diarrhea, refractory nausea,vomiting, or any other condition that will interfere significantly with drug absorption
    [...]
    For other Exclusion Criteria, please, see the protocol.
    1. Trattamento anti-tumorale, intervento chirurgico importante o uso di qualsiasi farmaco sperimentale nei 28 giorni precedenti l'inizio dello studio; la radioterapia palliativa è consentita se avvenuta > 7 giorni prima della prima dose pianificata per questo studio e l'eventuale tossicità è Grado <=1.
    2. Prove cliniche o istologiche di trasformazione in un sottotipo più aggressivo di linfoma o grado 3b FL o trasformazione di Richter o CLL.
    3. Precedente ricezione di trapianto allogenico di cellule staminali ematopoietiche (HSCT)
    4. Precedente trattamento con un inibitore PI3K
    5. Ipersensibilità nota a duvelisib e/o ai suoi eccipienti
    6. Storia o condizione concomitante di malattia polmonare interstiziale di qualsiasi gravità e/o funzione polmonare gravemente compromessa.
    7. Episodi precedenti di colite indotta da farmaci o polmonite indotta da farmaci
    8. Essere stati curati per la tubercolosi nei 2 anni precedenti la randomizzazione.
    9. Somministrazione di un vaccino vivo o attenuato nelle 6 settimane dalla randomizzazione.
    10. Trattamento in corso con immunosoppressori cronici (ad es. ciclosporina) o steroidi sistemici > 20 mg di prednisone (o equivalente) al giorno.
    11. Trattamento in corso per infezioni sistemiche batteriche, fungine o virali allo screening
    • Nota: I soggetti sottoposti a profilassi antimicrobica, antimicotica o antivirale non sono espressamente esclusi se sono soddisfatti tutti gli altri criteri di inclusione/esclusione
    12. Infezione da citomegalovirus attivo (CMV) o Epstein-Barr virus (EBV) attiva (cioè con carica virale rilevabile).
    13. Impossibilità di ricevere trattamenti profilattici per pneumocystis, herpes simplex virus (HSV) o herpes zoster (VZV) allo screening.
    14. Infezione da viurs dell’epatite B, epatite C, o immunodeficienza umana (HIV)
    • Saranno esclusi i soggetti ch risulteranno positivi per lo screening dell’antigene di superficie positivo all'epatite B [HBsAg] o dell’anticorpo dell'epatite C [HCV Ab].
    • I soggetti positivi per lo screening dell’anticorpo che riconosce il core dell'epatite B (HBcAb) devono risultare negativi per il test dell'acido desossiribonucleico (DNA) del virus dell'epatite B (HBV) per essere considerati idonei per questo studio e devono essere periodicamente monitorati per la riattivazione dell'HBV secondo le linee guida istituzionali.
    • I medici che credono fortemente che un test HBcAb positivo sia un falso positivo a causa di immunizzazione passiva da precedenti terapie immunoglobuliniche dovrebbero discutere con il Medical Monitor della possibilità di differire dalla profilassi dell'HBV.
    15. Somministrazione contemporanea di farmaci o alimenti che sono forti inibitori o induttori del citocromo P450 3A (CYP3A). Nessun uso nelle 2 settimane precedenti l'inizio dello studio.
    16. Soggetti con condizioni clinicamente significative di malassorbimento, malattie infiammatorie intestinali, condizioni croniche che si manifestano con diarrea, nausea refrattaria, vomito o qualsiasi altra condizione che interferisca significativamente con l'assorbimento del farmaco.
    [...]
    Per altri criteri di esclusione si faccia riferimento al protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    Overall Response Rate (ORR) according to the 2007 revised International Working Group (IWG) Criteria (Cheson 2007)
    Tasso di risposta complessiva (ORR) in base ai criteri rivisti del Gruppo di lavoro internazionale (IWG) del 2007 (Cheson 2007)
    E.5.1.1Timepoint(s) of evaluation of this end point
    ORR by Cheson 2007 (IWG criteria): 36 months
    ORR in base a Cheson 2007 (citeri IWG): 36 mesi
    E.5.2Secondary end point(s)
    • ORR according to 2014 Lugano criteria (Cheson 2014) Note: all additional secondary response endpoints as well as progression-free survival (PFS), will be assessed separately using 2007 revised IWG criteria (Cheson 2007) and 2014 Lugano criteria (Cheson 2014)
    • ORR, at 6, 12, 18, and 24 months after first dose of study intervention
    • Progression-free Survival
    • Time to Treatment Failure (TTF)
    • Duration of Response (DOR)
    • Overall Survival (OS)
    • Lymph Node Response Rate (LNRR)
    • Time to the First Response (TTFR)
    • Adverse events (AEs), serious AEs (SAEs), vital signs, physical examination, and clinical laboratory values
    • PK parameters for duvelisib and metabolite IPI-656
    EXPLORATORY END POINTS
    • Eastern Cooperative Oncology Group (ECOG) Performance Score
    • EQ-5D-3L questionnaire responses, Blood assessments of immune cell populations, chemokines, cytokines, phosphorylated proteins, and/or circulating tumor ctDNA
    • Fecal assessments of protein, DNA, and or RNA
    • Tumor biopsy evaluation of biomarkers such as gene and copy number variation, RNA expression, protein expression, and/or immune cell content
    • ORR in base ai criteri di Lugano del 2014
    (Cheson 2014) NB: tutti gli endpoint di risposta secondari aggiuntivi, nonché la sopravvivenza libera da progressione (PFS), saranno valutati separatamente, mediante i criteri IWG rivisti del 2007 (Cheson 2007)e i criteri di Lugano del 2014 (Cheson 2014)
    • ORR a 6, 12, 18 e 24 mesi dopo la prima dose di trattamento dello studio
    • Sopravvivenza libera da progressione
    • Tempo al fallimento della terapia (TTF)
    • Durata della risposta (DOR)
    • Sopravvivenza globale (OS)
    • Tasso di risposta dei linfonodi (LNRR)
    • Tempo alla prima risposta (TTFR)
    • Eventi avversi (EA), EA gravi (SAE), segni vitali, esami fisici e valori clinici di laboratorio
    • Parametri PK per duvelisib e il metabolita IPI-656
    END POINT ESPLORATIVI
    Punteggio relativo allo stato delle prestazioni del Gruppo cooperativo orientale di oncologia (ECOG)
    Risposte al questionario EQ-5D-3L
    Valutazioni di popolazioni di cellule immunitarie, chemochine, citochine, proteine fosforilate e/o DNA del tumore circolante (ctDNA) nel sangue
    Valutazioni di proteine, DNA e/o RNA nelle feci
    Valutazione, mediante biopsia tumorale, di biomarcatori quali variazione del numero di geni e di copie, espressione dell’RNA, espressione delle proteine e/o contenuto di cellule immunitarie
    E.5.2.1Timepoint(s) of evaluation of this end point
    ORR by Cheson 2014 ( Lugano criteria) at 6, 12, 18 and 34 months: 36 months
    PFS by Cheson 2007: 5 years
    TTF: 5 years
    DOR 5 years
    OS: 5 years
    LNRR: 36 months
    TTFR: 36 months
    Safety: 36 months
    PK: 36 months

    Exploratory
    ECOG: 5 years
    EQ-5D-3L: 5 years
    Biomarkers: 5 years
    ORR in base ai Cheson 2014 (criteri Lugano) a 6, 12, 18 e 34 mesi: 36 mesi
    PFS in base a Cheson 2007: 5 anni
    TTF: 5 anni
    DOR: 5 anni
    OS: 5 anni
    LNRR: 36 mesi
    TTFR: 36 mesi
    Safety: 36 mesi
    PK: 36 mesi

    Esplorativo
    ECOG: 5 anni
    EQ-5D-3L: 5 anni
    Biomarkers: 5 anni
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 concerned10
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Korea, Republic of
    Russian Federation
    United States
    Czechia
    Germany
    Italy
    Poland
    United Kingdom
    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 years3
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    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: 51
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 51
    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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 73
    F.4.2.2In the whole clinical trial 102
    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)
    Subjects receiving clinical benefit may continue receiving treatment even if the study has either met the primary endpoint or has followed the last randomized subject for 5 years, whichever is later. If the study is ended prior to all subjects discontinuing treatment, any subject continuing to receive benefit will be provided the opportunity to continue to receive duvelisib.Long-term continued treatment will be
    provided either in a separate study or EAP consistent with local regulations.
    I soggetti con benefici clinici potranno continuare a ricevere il trattamento anche se lo studio ha raggiunto l'endpoint primario o 'ultimo soggetto randomizzato è stato seguito per 5 anni, in base a quale avvenga prima. Se lo studio termina prima che tutti i soggetti abbiano interrotto il trattamento, ai soggetti che traggono beneficio sarà data l'opportunità di continuare a ricevere duvelisib..Il trattamento a lungo termine sarà fornito in studio separato o con EAP secondo requisiti locali.
    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 Decision2019-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-11
    P. End of Trial
    P.End of Trial StatusOngoing
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