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    Summary
    EudraCT Number:2017-004630-29
    Sponsor's Protocol Code Number:FIL_VERT
    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:2021-06-14
    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 number2017-004630-29
    A.3Full title of the trial
    A phase II, open label, multicenter trial of Venetoclax (ABT-199/GDC-0199) as single agent in patients with relapsed/refractory BCL-2 positive peripheral T cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL) and other nodal T-cell lymphomas of T-follicular helper origin (TFH).
    Venetoclax (ABT-199/GDC-0199) in monoterapia per il trattamento di pazienti con diagnosi di linfoma T periferico ricaduto/refrattario BCL-2 positivo del tipo non altrimenti specificato (PTCL-NOS), angioimmunoblastico (AITL) o nodale di origine T-helper follicolare (TFH): studio fase II, in aperto, multicentrico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II, open label, multicenter trial of Venetoclax as single agent in patients with relapsed/refractory BCL-2 positive peripheral T cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL) and other nodal T-cell lymphomas of T-follicular helper origin (TFH).
    Venetoclax in monoterapia per il trattamento di pazienti con diagnosi di linfoma T periferico ricaduto/refrattario BCL-2 positivo del tipo non altrimenti specificato (PTCL-NOS), angioimmunoblastico (AITL) o nodale di origine T-helper follicolare (TFH): studio fase II, in aperto, multicentrico.
    A.3.2Name or abbreviated title of the trial where available
    FIL_VERT
    FIL_VERT
    A.4.1Sponsor's protocol code numberFIL_VERT
    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 supportAbbVie S.r.l.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione Italiana Linfomi Onlus
    B.5.2Functional name of contact pointUffici Studi FIL - Area Start up
    B.5.3 Address:
    B.5.3.1Street Addressc/o Dipartimento di Scienze Mediche e Chirurgiche Materno-Infantili e dell'Adulto Università di Mode
    B.5.3.2Town/ cityModena
    B.5.3.3Post code41121
    B.5.3.4CountryItaly
    B.5.4Telephone number00390594222688
    B.5.5Fax number00390594223602
    B.5.6E-mailstartup@filinf.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 VENCLYXTO - 10 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/PE/PCTFE-ALU) - 14 (7X2) COMPRESSE (DOSE UNITARIA)
    D.2.1.1.2Name of the Marketing Authorisation holderABBVIE LTD
    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.3.1Product nameVenetoclax
    D.3.2Product code [IMP1]
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNvenetoclax
    D.3.9.1CAS number 1257044-40-8
    D.3.9.2Current sponsor codeIMP1
    D.3.9.3Other descriptive nameVenetoclax, ABT-199, A-1195425.0, GDC-0199, RO5537382, Venclexta®, and Venclyxto®
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 VENCLYXTO - 50 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/PE/PCTFE-ALU) - 7 (7X1) COMPRESSE (DOSE UNITARIA)
    D.2.1.1.2Name of the Marketing Authorisation holderABBVIE LTD
    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.3.1Product nameVenetoclax
    D.3.2Product code [IMP2]
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNvenetoclax
    D.3.9.1CAS number 1257044-40-8
    D.3.9.2Current sponsor codeIMP2
    D.3.9.3Other descriptive nameVenetoclax, ABT-199, A-1195425.0, GDC-0199, RO5537382, Venclexta®, and Venclyxto®
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name VENCLYXTO - 100 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/PE/PCTFE-ALU) - 112 (4X28) COMPRESSE (DOSE UNITARIA)
    D.2.1.1.2Name of the Marketing Authorisation holderABBVIE LTD
    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.3.1Product nameVenetoclax
    D.3.2Product code [IMP3]
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNvenetoclax
    D.3.9.1CAS number 1257044-40-8
    D.3.9.2Current sponsor codeIMP3
    D.3.9.3Other descriptive nameVenetoclax, ABT-199, A-1195425.0, GDC-0199, RO5537382, Venclexta®, and Venclyxto®
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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 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
    Patients with relapsed/refractory BCL-2 positive peripheral T cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL) and other nodal T-cell lymphomas of T-follicular helper origin (TFH)
    Pazienti con diagnosi di linfoma T periferico ricaduto/refrattario BCL-2 positivo del tipo non altrimenti specificato (PTCL-NOS), angioimmunoblastico (AITL) o nodale di origine T-helper follicolare (TFH)
    E.1.1.1Medical condition in easily understood language
    Patients with relapsed/refractory peripheral T cell lymphoma
    Pazienti con diagnosi di linfoma T periferico ricaduto/refrattario
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10042980
    E.1.2Term T-cell lymphoma refractory
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10042979
    E.1.2Term T-cell lymphoma recurrent
    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 ABT-199 in terms of overall response rate (ORR).
    Valutare l’efficacia di ABT-199 in termini di risposta globale (ORR).
    E.2.2Secondary objectives of the trial
    To assess the efficacy and safety of ABT-199 as measured by:
    - Complete response rate (CR); Partial response rate (PR); Stable Disease rate (SD);
    - Overall Survival (OS);
    - Time to response (TTR);
    - Duration of response (DoR);
    - Progression Free Survival (PFS);
    - Duration of Treatment;
    - Safety of ABT-199 in terms of relevant toxicity;
    - Safety of ABT-199 in terms of overall toxicity;

    Explorative objectives
    • To assess the relationship between response and level of BCL-2 expression
    Obiettivi secondari
    Valutare l’efficacia e la sicurezza di ABT-199 in termini di:
    • Risposta completa (CR); Risposta parziale (PR); Malattia stabile (SD);
    • Sopravvivenza (OS);
    • Tempo alla risposta (TTR);
    • Durata della risposta (DoR);
    • Sopravvivenza libera da progressione (PFS);
    • Durata del trattamento;
    • Sicurezza di ABT-199 in termini di tossicità rilevante;
    • Sicurezza di ABT-199 in termini di tossicità globale;

    Obiettivi esplorativi
    Valutare la relazione tra risposta ed i livelli di espressione di BCL-2 nella biopsia tumorale
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Histologically documented diagnosis of BCL-2 positive PTCL-NOS, AITL, TFH as defined in the 2016 edition of the World Health Organization (WHO) classification. Only patients with percentage of BCL-2 positive tu-mor cells >= 25% in the relapse biopsy, if available, or otherwise in the ini-tial biopsy, will be included onto the study;
    • Age >= 18 years
    • Relapsed or refractory to at least one previous standard line of treatment
    • Eastern Cooperative Oncology Group (ECOG) performance status (PS) <= 2
    • At least one site of measurable nodal or extranodal disease at baseline >= 2.0 cm in the longest transverse diameter as determined by CT scan (MRI is allowed only if CT scan cannot be performed). Note: Patients with only bone marrow involvement are eligible
    • Adequate hematological counts defined as follows:
    - Absolute Neutrophil count (ANC) > 1.0 x 10^9/L unless due to bone marrow involvement by lymphoma
    - Platelet count >= 50.000/mm^3 unless due to bone marrow involvement by lymphoma
    • Adequate renal function defined as follows:
    - Creatinine clearance >= 30 mL/min
    • Adequate hepatic function per local laboratory reference range as follows:
    - Aspartate transaminase (AST) and alanine transaminase (ALT) <= 3.0 x ULN
    - Bilirubin <=1.5 x ULN (unless bilirubin rise is due to Gilbert’s syn-drome or of non-hepatic origin)
    • Subject understands and voluntarily signs an informed consent form ap-proved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific proce-dures
    • Subject must be able to adhere to the study visit schedule and other pro-tocol requirements
    •Subject must be able to swallow capsules or tablets
    • Life expectancy >= 3 months
    • Women must be:
    - postmenopausal for at least 1 year (must not have had a natural menses for at least 12 months)
    - surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),
    - completely abstinent (periodic abstinence from intercourse is not permit-ted) or if sexually active, be practicing a highly effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double barrier method (e.g.: condoms, diaphragm, or cervical cap, with spermicidal foam, cream, or gel, male partner sterilization) as local regulations permit, before entry, and must agree to continue to use the same method of contraception throughout the study. They must also be prepared to continue birth con-trol measures for at least 1 month after terminating treatment.
    - women of childbearing potential must have a negative pregnancy test at screening
    • Men must agree to use an acceptable method of contraception (fort them-selves or female partners as listed above) for the duration of the study. Men must agree to use a double barrier method of birth control and to not donate sperm during the study and for 1 month after receiving the last dose of study drug.
    Male even if surgically sterilized (i.e., status postvasectomy) must agree to 1 of the following:
    - practice effective barrier contraception during the entire study treatment period and through 1 months after the last dose of study drug, or
    - agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception)
    • Diagnosi documentata istologicamente di PTCL-NOS, AITL, TFH BCL-2 positivo in accordo con i criteri della Classificazione WHO 2016. Solo i pazienti che presenteranno una positività di BCL-2 nelle cellule tumorali >= 25% nella biopsia della ricaduta o, se questa non risultasse disponibile, nella biopsia iniziale della diagnosi potranno essere arruolati
    • Età>= 18 anni
    • Malattia ricaduta/refrattaria ad almeno una precedente linea di terapia
    • Performance Status (PS) ECOG<= 2
    • Almeno una sede nodale o extranodale misurabile di malattia al basale >= 2.0 cm nel diametro trasverso principale valutata mediante scansione TC (la RMN è consentita solo se vi sono controindicazioni ad eseguire la TC). Nota: i pazienti che presentano un interessamento del midollo osseo, pur in assenza di altre localizzazioni di malattia, sono ugualmente eleggibili
    • Valori emocromo adeguati come di seguito riportati:
    -Conta assoluta di granulociti neutrofili (ANC)> 1.0 x 10^9/L salvo una conta inferiore per infiltrazione midollare da linfoma
    -Conta piastrinica >= 50.000/mm^3 salvo una conta inferiore per infiltrazione midollare da linfoma
    • Adeguata funzionalità renale come di seguito definita:
    - Clearance creatinina >= 30 mL/min
    • Adeguata funzionalità epatica con parametri di laboratorio così definiti:
    - Aspartato amino-transferasi (AST) e alanina amino-transferasi (ALT) <= 3.0 x ULN
    - Bilirubina <=1.5 x ULN (a meno che l’incremento della bilirubina sia espressione di una sindrome di Gilbert syndrome o abbia una origine non epatica)
    • Capacità del paziente di intendere e firmare il modulo di consenso informato approvato da un Comitato Etico Indipendente prima di iniziare la fase di screening o ogni altra procedura collegata allo studio
    • Il paziente deve essere capace di aderire al programma di valutazioni o procedure previste dallo studio
    • Il paziente deve essere in grado di ingerire capsule/compresse
    • Aspettativa di vita >= 3 mesi
    • Le pazienti di sesso femminile devono risultare in una delle seguenti condizioni:
    -Essere in fase di post menopausa da almeno 1 anno (assenza di ciclo mestruale da almeno 1 anno)
    - Aver praticato una forma di sterilità chirurgica (isterectomia, annessiectomia bilaterale, tubarectomia bilaterale, legatura delle tube, o altra situazione di incapacità alla gravidanza)
    - Seguire astinenza completa (una astinenza periodica non è consentita) o, in caso di attività sessuale, impiegare un valido metodo contracettivo (es. uso di contraccettivi orali, iniettivi, epidermici, dispositivi intrauterini, dispositivi a doppia barriera (es.: profilattici, diaframma, cappuccio uterino, con schiuma, crema o gel spermicida, stato di sterilità del partner maschile) come da regolamentazione locale, prima di entrare nello studio, e consentire di continuare ad adottare lo stesso metodo di contraccezione per tutta la durata dello studio. Le pazienti devono essere preparate a proseguire il programma di controllo delle nascite per almeno un mese dopo aver terminato il trattamento
    - Le donne in età fertile devono avere un test di gravidanza negativo al momento dello screening
    • I pazienti di sesso maschile devono accettare di seguire validi metodi contraccettivi (per se stessi o per le loro partners come indicato precedentemente) per tutta la durata dello studio. I pazienti di sesso maschile devono accettare di impiegare un metodo contraccettivo a doppia barriera e di non donare lo sperma durante lo studio e per almeno un mese dopo il termine del trattamento
    • I pazienti di sesso maschile anche se sterili (es. orchiectomia) devono accettare di seguire almeno una delle seguenti pratiche:
    - praticare un metodo effettivo contraccettivo di barriera durante tutto il periodo dello studio e per almeno un mese dopo il termine del trattamento o
    - accettare di praticare assoluta astinenza quando questo comportamento risulti in linea con le abitudini del loro stile di vita
    E.4Principal exclusion criteria
    •Histological diagnosis different from BCL-2 positive PTCL-NOS, AITL, and TFH
    • Allogeneic or autologous stem cell transplant within 6 months prior to the informed consent signature
    • Treatment with any of the following within 7 days prior to the first dose of study drug:
    - steroid therapy for anti-neoplastic intent
    - moderate or strong cytochrome P450 3A (CYP3A) inhibitors (see Ap-pendix C for examples)
    - moderate or strong CYP3A inducers (see Appendix C for examples)
    • Subject has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, investigational therapy, including targeted small molecule agents within 14 days prior to the first dose of study drug
    • History of CNS involvement by lymphoma
    • Administration or consumption of any of the following within 3 days prior to the first dose of study drug:
    - grapefruit or grapefruit products
    - Seville oranges (including marmalade containing Seville oranges)
    - star fruit
    • Previous treatment with a BCL-2 family protein inhibitor
    • Subject is known to be positive for HIV (HIV testing is not required)
    • Cardiovascular disease (NYHA class >=2)
    • Creatinine Clearance < 30 mL/min
    • Significant history of neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent.
    • Any history of other active malignancies within 3 years prior to study entry, with the exception of adequately treated in situ carcinoma of the cervix uterine, basal cell carcinoma of the skin or localized squamous cell carci-noma of the skin, previous malignancy confined and surgically resected with curative intent.
    • Subject who has malabsorption syndrome or other condition which pre-cludes enteral route of administration.
    • Evidence of other clinically significant uncontrolled condition(s) including, but not limited to uncontrolled and/or active systemic infection (viral, bacte-rial or fungal)
    • Active HBV positive hepatitis
    -The following categories of patients HBV positive but with non evidence of active hepatitis may be considered for the study:
    - HBsAg positive with HBV DNA < 2000 UI/ml (inactive carriers); HBV DNA > 2000 UI/ml is criteria of exclusion
    - HBsAg negative but HBsAb positive
    - HBsAg negative but HBcAb positive
    - Patients HBsAg positive with HBV DNA < 2000 UI/ml and HBsAg nega-tive but HBcAb positive will be eligible for the study only if they accept to receive prophylactic Lamivudine 100 mg/daily for all the period of treat-ment and at least for 12 months after the end of therapy. Treatment with ABT-199 should be stopped in case of hepatitis reactivation.
    • Active HCV positive hepatitis
    • If female, the patient is pregnant or breast-feeding.
    • Diagnosi istologica diversa da PTCL-NOS, AITL e TFH BCL-2 positivo
    • Trapianto allogenico o autologo di cellule staminali emopoietiche entro i 6 mesi precedenti la firma del consenso informato
    • Trattamento con uno dei seguenti agenti terapeutici entro i 7 giorni antecedenti la prima dose del farmaco in studio:
    - Terapia steroidea con finalità anti-tumorale
    - Inibitori moderati o forti del citocromo P450 3A (CYP3A) (vedere Appendice C del protocollo per esempi)
    - Induttori moderati o forti di CYP3A (vedere Appendice C del protocollo per esempi)
    • Il paziente ha ricevuto una qualsiasi terapia anti-tumorale inclusa chemioterapia, immunoterapia, radioterapia, terapia sperimentale, incluse molecole di nuova generazione bersaglio specifiche entro i 14 giorni precedenti la prima dose del farmaco in studio (NB: la somministrazione di una singola dose di vincristina 1 mg nella fase di screening, se clinicamente indicata, è permessa)
    • Anamnesi positive per interessamento al sistema nervoso centrale da parte del linfoma
    • Somministrazione o consumo di uno dei seguenti alimenti nei 3 giorni precedenti la prima dose del farmaco in studio:
    - Pompelmo o prodotti a base di pompelmo
    - Arance di Siviglia (inclusa marmellata contenente arance di Siviglia)
    - Frutto stella
    • Precedente trattamento con un inibitore di BCL-2
    • Pazienti con nota positività per HIV (il test HIV non è richiesto)
    • Malattia cardiovascolare (classe NYHA >=2)
    • Clearance della creatinina < 30 mL/min
    • Anamnesi positive per patologie neurologiche, psichiatriche, endocrinologiche, metaboliche, immunologiche o epatiche che potrebbero precludere la partecipazione allo studio o compromettere la capacità di fornire un consenso informato
    • Anamnesi di altra neoplasia attiva nei tre anni precedenti l’entrata nello studio, con l’eccezione del carcinoma in situ della cervice uterina, del carcinoma basocellulare della cute o del carcinoma squamocellulare della cute localizzato adeguatamente trattati, o di una precedente neoplasia confinata e resecata chirurgicamente con intento curativo.
    • Soggetto con una sindrome da malassorbimento o altra condizione che impedisce la via di somministrazione enterale
    • Evidenza di un’altra condizione clinicamente significativa non controllata, inclusa ma non limitata a infezione sistemica attiva e/o non controllata (virale, batterica o fungina)
    • Epatite HBV positiva in fase di attività
    Le seguenti categorie di pazienti HBV positivi senza segni di epatite attiva possono invece essere considerate eleggibili per lo studio:
    - HBsAg positività con HBV DNA < 2000 UI/ml (carriers inattivi); un valore di HBV DNA > 2000 UI/ml è un criterio di esclusione;
    - HBsAg negatività con HBsAb positività;
    - HBsAg negatività con HBcAb positività
    I pazienti HBsAg positivi con HBV DNA < 2000 UI/ml ed i pazienti HBsAg negativi HBcAb positivi potranno essere eleggibili allo studio solo se accetteranno di assumerere una profilassi antivirale con Lamivudina 100 mg/die per tutto il periodo di studio e per almeno 12 mesi dopo la fine del trattamento. Il trattamento con ABT-199 sarà sospeso in caso riattivazione epatitica.
    •Epatite HCV in fase di attività
    •Pazienti di sesso femminile in gravidanza o allattamento
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate (ORR)
    Tasso di risposta globale (ORR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    After the first 3 cycles or, in case of discontinuation, at the EoT visit
    Dopo i primi tre cicli di trattamento o nel caso di interruzione, alla visita di End Of Treatment
    E.5.2Secondary end point(s)
    Complete remission (CR); Partial response (PR); Stable Desease (SD); Time To Response (TTR); Duration of Remission (DoR); Progression free Sruvival (PFS); Overall Survival (OS); Duration of treatment (DoT); Safety
    Remissione Completa (CR) ; Risposta parziale (PR); Malattia Stabile (SD); Tempo alla risposta (TTR); Durata della remissione (DoR) ; Sopravivvenza libera da Progressione (PFS); Sopravvivenza globale (OS); Durata del trattamento (DoT); Sicurezza
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 3 cycles from the date of the first dose and at each restaging; After 3 cycles from the date of the first dose and at each restaging; After 3 cycles from the date of the first dose and at each restaging; 1 year from the date of the first dose; 6 months from the first response assesment; 1 year from the date of the first dose; 1 year from the date of the first dose; 1 year from the date of the first dose; Throughout all the active treatment period
    Dopo 3 cicli dalla prima dose e ad ogni restaging; Dopo 3 cicli dalla prima dose e ad ogni restaging; Dopo 3 cicli dalla prima dose e ad ogni restaging; 1 anno dalla data della prima somministrazione; 6 mesi dalla prima valutazione della risposta; 1 anno dalla data della prima somministrazione; 1 anno dalla data della prima somministrazione; 1 anno dalla data della prima somministrazione; Durante tutto il periodo di trattamento
    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 Yes
    E.8.1.7.1Other trial design description
    Studio di fase II, aperto, multicentrico a singolo braccio con disegno a due stadi (secondo Simon)
    Open-label, multi-center, single arm phase II trial, with a two-stage design
    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 concerned21
    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 Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    12 mesi dopo l'inizio del trattamento dell'ultimo paziente.
    12 months after the start of treatment of the last patient
    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 months30
    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 months30
    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: 17
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 35
    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)
    According to clinical practise at the discretion of the investigator
    A discrezione del medico curante secondo pratica clinica
    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 Decision2018-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-24
    P. End of Trial
    P.End of Trial StatusOngoing
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