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    The EU Clinical Trials Register currently displays   41467   clinical trials with a EudraCT protocol, of which   6815   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2020-004199-16
    Sponsor's Protocol Code Number:ME-401-004
    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:2021-08-02
    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 number2020-004199-16
    A.3Full title of the trial
    A Phase 3, Randomized, Open-Label, Controlled, Multicenter Study of Zandelisib (ME-401) in Combination with Rituximab Versus Standard Immunochemotherapy in Patients with Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL) – The COASTAL Study
    Studio di fase 3, randomizzato, in aperto, controllato, multicentrico su zandelisib (ME-401) in combinazione con rituximab rispetto a immunochemioterapia standard in pazienti con linfoma non Hodgkin indolente (LNHi) recidivante – Studio COASTAL
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Zandelisib (ME-401) in Combination with Rituximab Versus Standard Therapy in Patients with Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL)
    Studio su zandelisib (ME-401) in combinazione con rituximab rispetto a terapia standard in pazienti con linfoma non Hodgkin indolente (LNHi) recidivante
    A.3.2Name or abbreviated title of the trial where available
    The COASTAL Study
    Studio COASTAL
    A.4.1Sponsor's protocol code numberME-401-004
    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 SponsorMEI Pharma 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 supportMEI Pharma, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMEI Pharma, Inc.
    B.5.2Functional name of contact pointMEI Pharma
    B.5.3 Address:
    B.5.3.1Street Address11455 El Camino Real, Suite 250
    B.5.3.2Town/ citySan Diego, CA
    B.5.3.3Post code92130
    B.5.3.4CountryUnited States
    B.5.6E-mailpatients@meipharma.com
    D. IMP Identification
    D.IMP: 1
    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 Prednison HEXAL 20 mg
    D.2.1.1.2Name of the Marketing Authorisation holderHexal AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePrednison HEXAL 20 mg
    D.3.2Product code [-]
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor code-
    D.3.9.3Other descriptive namePrednisone
    D.3.9.4EV Substance CodeSUB10020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 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 Truxima 500 mg
    D.2.1.1.2Name of the Marketing Authorisation holderCelltrion Healthcare Hungary Kft.
    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 nameTruxima
    D.3.2Product code [-]
    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.3.8INN - Proposed INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.2Current sponsor code-
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 No
    D.IMP: 3
    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 Truxima 100 mg
    D.2.1.1.2Name of the Marketing Authorisation holderCelltrion Healthcare Hungary Kft.
    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 nameTruxima
    D.3.2Product code [-]
    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.3.8INN - Proposed INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.2Current sponsor code-
    D.3.9.4EV Substance CodeSUB12570MIG
    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 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 No
    D.IMP: 4
    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 Endoxan
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter Polska Sp. z o.o.
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 nameEndoxan
    D.3.2Product code [-]
    D.3.4Pharmaceutical form Powder 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 6055-19-2
    D.3.9.2Current sponsor code-
    D.3.9.3Other descriptive nameCyclophosphamide Monohydrate
    D.3.9.4EV Substance CodeSUB16414MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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: 5
    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 Cellcristin
    D.2.1.1.2Name of the Marketing Authorisation holderSTADApharm GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCellcristin
    D.3.2Product code [-]
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor code-
    D.3.9.3Other descriptive nameVincristine Sulfate
    D.3.9.4EV Substance CodeSUB05101MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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: 6
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameZandelisib
    D.3.2Product code [ME-401]
    D.3.4Pharmaceutical form Capsule
    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 INNzandelisib
    D.3.9.1CAS number 1401436-95-0
    D.3.9.2Current sponsor code-
    D.3.9.4EV Substance CodeSUB178477
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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: 7
    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 Bendamustin
    D.2.1.1.2Name of the Marketing Authorisation holderHikma Farmacêutica (Portugal) S. A.
    D.2.1.2Country which granted the Marketing AuthorisationPortugal
    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 nameBendamustin
    D.3.2Product code [-]
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 3543-75-7
    D.3.9.2Current sponsor code-
    D.3.9.3Other descriptive nameBendamustine Hydrochloride
    D.3.9.4EV Substance CodeSUB00696MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2500
    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: 8
    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 DOXO-cell 50 mg
    D.2.1.1.2Name of the Marketing Authorisation holderSTADApharm GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDOXO-cell 50 mg
    D.3.2Product code [-]
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNDOXORUBICINA CLORIDRATO
    D.3.9.1CAS number 25316-40-9
    D.3.9.2Current sponsor code-
    D.3.9.4EV Substance CodeSUB01827MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    Relapsed or refractory follicular lymphoma (FL) or marginal zona lymphoma (MZL)
    Lifoma follicolare (LF) o linfoma della zona marginale (LZM) recidivante o refrattario
    E.1.1.1Medical condition in easily understood language
    Follicular lymphoma is a type of blood cancer. It is the most common of the indolent (slow-growing) non-Hodgkin's lymphomas, and the second-most-common form of non-Hodgkin's lymphomas overall.
    Il linfoma follicolare è un tipo di tumore del sangue. E’ il più comune dei linfomi non Hodking indolenti (a crescita lenta) e la seconda forma più comune di linfomi non Hodking in generale.
    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 24.0
    E.1.2Level LLT
    E.1.2Classification code 10029473
    E.1.2Term Nodular (follicular) lymphoma
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10076596
    E.1.2Term Marginal zone lymphoma
    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 demonstrate that zandelisib in combination with R is superior to standard immunochemotherapy in prolonging PFS as determined by the Independent Response Review Committee (IRRC) in previously treated subjects with follicular and marginal zone lymphoma
    Dimostrare che zandelisib in combinazione con R è superiore all’immunochemioterapia standard in termini di prolungamento di PFS, secondo quanto determinato dal Comitato indipendente di revisione della risposta (IRRC), in soggetti precedentemente trattati affetti da linfoma follicolare e della zona marginale.
    E.2.2Secondary objectives of the trial
    - To compare zandelisib + R to standard immunochemotherapy by ORR and complete response rate (CRR) as determined by the IRRC
    - To compare zandelisib + R to standard immunochemotherapy by overall survival (OS)
    - To evaluate Patient Reported Outcome (PRO) assessment with FlymSI18
    - To evaluate PRO with EuroQol 5 Dimension (EQ-5D)
    - To evaluate the safety and tolerability of zandelisib in combination with R
    - Confrontare zandelisib + R con l’immunochemioterapia standard in termini di ORR e tasso di risposta completa (CRR), secondo quanto determinato dall’IRRC
    - Confrontare zandelisib + R con l’immunochemioterapia standard in termini di sopravvivenza globale (OS)
    - Valutare gli esiti riferiti dal paziente (PRO) mediante il questionario per la valutazione funzionale della terapia tumorale a 18 voci specifico per l’indice dei sintomi del linfoma (FlymSI-18)
    - Valutare i PRO mediante il questionario europeo sulla qualità della vita a 5 dimensioni (EQ-5D)
    - Valutare la sicurezza e la tollerabilità di zandelisib in combinazione con R
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects >=18 years of age, >=19 years in Korea, or >=20 years for subjects in Japan and Taiwan, at time of signing informed consent
    2. Histologically confirmed diagnosis of CD20 positive iNHL with histological subtype limited to:
    a. FL Gr 1, Gr 2, or Gr 3a
    b. MZL (splenic, nodal, or extra-nodal)
    [Histopathological report confirming diagnosis must be available during screening procedures]
    3. Subjects with relapsed or refractory disease who received >=1 prior lines of therapy that must have included an anti-CD20 antibody in combination with cytotoxic chemotherapy or L, with or without subsequent maintenance therapy. [A line of therapy is defined as following: a minimum of 2 consecutive cycles of immunochemotherapy or R-L, at least 4 doses of anti-CD20 mAb (R) single agent therapy a minimum of 2 consecutive cycles of therapy with an investigational agent. Maintenance therapy given after an induction treatment (e.g., R maintenance) is considered as the same line of therapy]. [Please seeExclusion Criteria #2 for further clarification]. Relapsed or refractory disease defined as:
    - Relapsed disease: disease progression after a response (complete response [CR] or partial response [PR]) lasting >=6 months
    - Refractory disease: no response to therapy (no CR or PR) or response lasting <6 months
    4. Subjects must have at least one bi-dimensionally measurable lesion >1.5 cm (that has not been previously irradiated) according to the Lugano Classification
    5. Adequate hematologic parameters at screening unless abnormal values are due to disease per Investigator assessment:
    - Absolute neutrophil count (ANC) >=1.0 × 109/L (>=1,000/mm3)
    - Platelet count >=75.0 × 109/L (>=75,000/mm3)
    - Hemoglobin >=9 g/dL
    6. Adequate renal and hepatic function per local laboratory reference range at screening as follows:
    - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) <=1.5 × upper limit of normal (ULN)
    - Total bilirubin <=2.0 × ULN or <=3 × ULN for subjects with GilbertMeulengracht syndrome
    - Estimated glomerular filtration rate (eGFR) >50 mL/min using the Cockcroft-Gault equation (Appendix 2)
    7. QT-interval corrected according to Fridericia's formula (QTcF) <=450 msec; subjects with QTc >450 msec but <480 msec may be enrolled provided the QTc prolongation is due to a right bundle branch block (RBBB), left bundle branch block (LBBB), or pacemaker and is confirmed stable by a cardiologist.
    8. Left ventricular ejection fraction (LVEF) >=45% as measured by echocardiogram (ECHO) or multi-gated acquisition scan. [If LVEF <45% by ECHO, a repeat measurement can be conducted within the screening period.]
    9. Subjects must have completed any prior systemic anti-cancer treatment >=4 weeks (or >=5 times the half-life [t½] of used therapeutics [including investigational therapy], whichever is longer) or radiation therapy >=2 weeks before study D1, and >=3 months before study D1 for high dose therapy with stem cell transplantation, radioimmunotherapy, and CAR T-cell therapy.
    10. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
    11. Life expectancy of at least 3 months
    12. All AEs and laboratory toxicities related to prior therapy must resolve to Gr <=1 prior to the start of the study therapy (unless otherwise specified in eligibility criteria)
    13. For females of childbearing potential, a negative serum human chorionic gonadotropin (hCG) pregnancy test within 28 days of study D1 and negative hCG result on study D1
    14. Subjects must agree to use appropriate contraception methods during the clinical study (Appendix 3)
    15. Subject is willing and able to comply with all scheduled visits, treatment plans, laboratory tests, and other study procedures
    1. Soggetti di sesso femminile o maschile di età >= 18 anni, >= 19 anni in Corea o >= 20 anni per soggetti in Giappone e Taiwan, al momento della firma del consenso informato
    2. Diagnosi confermata istologicamente di LNHi CD20-positivo, con sottotipo istologico limitato a:
    a. LF di Gr 1, Gr 2 o Gr 3a
    b. LZM (splenico, nodale o extranodale)
    [Il referto istopatologico a conferma della diagnosi deve essere disponibile durante le procedure di screening]
    3. Soggetti con malattia recidivante o refrattaria sottoposti a >= 1 precedente linea di terapia, che devono aver incluso un anticorpo anti-CD20 in combinazione con chemioterapia citotossica o L, con o senza terapia di mantenimento successiva. [Per linea di terapia si intende quanto segue: un minimo di 2 cicli consecutivi di immunochemioterapia o R-L, almeno 4 dosi di terapia con mAb anti-CD20 (R) come singolo agente, un minimo di 2 cicli consecutivi di terapia con un agente sperimentale. La terapia di mantenimento somministrata dopo un trattamento di induzione (per es. mantenimento con R) è considerata la stessa linea di terapia]. [Si prega di consultare i Criteri di esclusione n. 2 per ulteriori chiarimenti]. Malattia recidivante o refrattaria definita come:
    - Malattia recidivante: progressione della malattia dopo una risposta (risposta completa [CR] o risposta parziale [PR]) di durata >= 6 mesi
    - Malattia refrattaria: nessuna risposta alla terapia (nessuna CR o PR) o risposta di durata < 6 mesi
    4. I soggetti devono presentare almeno una lesione misurabile bidimensionalmente > 1,5 cm (che non sia stata irradiata in precedenza) in base alla Classificazione di Lugano
    5. Adeguati parametri ematologici allo screening, a meno che i valori anomali non siano dovuti alla malattia, come da valutazione dello Sperimentatore:
    - Conta assoluta dei neutrofili (ANC) >= 1,0 × 109/l (>= 1.000/mm3)
    - Conta piastrinica >= 75,0 × 109/l (>= 75.000/mm3)
    - Emoglobina >= 9 g/dl
    6. Adeguata funzionalità renale ed epatica allo screening, in base all’intervallo di riferimento del laboratorio locale, che si presenta come segue:
    - Aspartato aminotransaminasi (AST)/alanina aminotransferasi (ALT) <= 1,5 volte il limite superiore della normalità (ULN)
    - Bilirubina totale <= 2,0 × ULN o <= 3 × ULN per soggetti con sindrome di Gilbert-Meulengracht
    - Velocità di filtrazione glomerulare stimata (eGFR) > 50 ml/min mediante l’equazione di Cockcroft-Gault (Appendice 2)
    7. Intervallo QT corretto secondo la formula di Fridericia (QTcF) <= 450 msec; i soggetti con QTc > 450 msec, ma < 480 msec, possono essere arruolati a condizione che il prolungamento del QTc sia dovuto a un blocco di branca destra (RBBB), blocco di branca sinistra (LBBB) o pacemaker e sia confermato come stabile da un cardiologo.
    8. Frazione di eiezione ventricolare sinistra (FEVS) >= 45% misurata mediante ecocardiogramma (ECO) o scansione con acquisizione a gate multipli. [Se LVEF risulta < 45% all’ECO, si può ripetere la misurazione entro il periodo di screening].
    9. I soggetti devono avere completato qualsiasi trattamento antitumorale sistemico precedente >= 4 settimane (o >= 5 volte l’emivita [t½] degli agenti terapeutici utilizzati [inclusa la terapia sperimentale], a seconda di quale sia il periodo più lungo) o radioterapia >= 2 settimane prima del G1 dello studio e >= 3 mesi prima del G1 dello studio per la terapia ad alto dosaggio con trapianto di cellule staminali, radioimmunoterapia e terapia con cellule T che esprimono un recettore chimerico per l’antigene (CAR).
    10. Stato di performance secondo l’Eastern Cooperative Oncology Group (ECOG) pari a 0-1.
    11. Aspettativa di vita di almeno 3 mesi.
    12. Tutti gli EA e le tossicità di laboratorio correlati alla terapia precedente devono risolversi al Gr <= 1 prima dell’inizio della terapia dello studio (salvo diverse specifiche presenti nei criteri di idoneità)

    Per tutti gli altri criteri, si prega di fare riferimento al Protocollo
    E.4Principal exclusion criteria
    1. Histologically confirmed diagnosis of FL Gr 3b or transformed disease
    - For subjects with clinical signs of rapid disease progression (e.g., marked B-symptoms), and laboratory or radiographic indication (e.g., high lactate dehydrogenase level or standardized uptake value by PET), a fresh biopsy is recommended to rule out transformed disease
    2. Subjects who received both R/O-B and R/O-CHOP (or other anthracycline-containing regimen) as previous lines of therapy, and those who received only single agent anti-CD20 mAb therapy as prior line of treatment
    3. Prior therapy with PI3K inhibitors
    4. Ongoing or history of drug-induced pneumonitis
    5. Known lymphomatous involvement of the central nervous system
    6. Seropositive for or active viral infection with hepatitis B virus:
    - HBsAg positive
    - HBsAg negative, anti-HBs positive and/or anti-HBc positive and detectable viral DNA by PCR [Note: Subjects who are HBsAg negative and viral DNA PCR negative are eligible. These subjects should receive prophylactic therapy for hepatitis as per institutional standards.]
    7. Known seropositive for, or active infection with hepatitis C virus.
    - Subjects with positive hepatitis C virus (HCV) antibodies are eligible
    with negative PCR test for HCV
    8. Known seropositive for, or active infection with human immunodeficiency virus
    9. Known seropositive for, or active infection with human T-cell leukemia virus type 1
    10. Any uncontrolled clinically significant illness including, but not limited to, active infections requiring systemic antimicrobial therapy, hypertension, angina, arrhythmias, pulmonary disease, or autoimmune dysfunction
    11. Hypersensitivity or other clinically significant reaction to the study drug or its inactive ingredients
    12. Major surgical procedure within 4 weeks prior to study D1 (minor surgical procedures, e.g., lymph node biopsy, performed within 1 day or with an overnight stay are allowed)
    13. Previous or concurrent cancer that is distinct in primary site or histology from indolent B cell NHL within 3 years before start of study treatment except for curatively treated cervical cancer in situ, nonmelanoma skin cancer, and superficial bladder tumors (Ta [non-invasive tumor], Tis [carcinoma in situ], and T1 [tumor invades lamina propria]), and asymptomatic localized prostate cancer with no requirement for systemic therapy or requiring only hormonal therapy and with normal prostate-specific antigen values within >=12 months prior to randomization
    14. History of clinically significant cardiovascular abnormalities such as congestive heart failure (New York Heart Association (NYHA) classification >= II [NYHA 1994]), myocardial infarction within 6 months of study entry.
    15. History of clinically significant gastrointestinal (GI) conditions, particularly:
    - Known GI condition that would interfere with swallowing or the oral absorption or tolerance of study drug
    - Pre-existing malabsorption syndrome or other clinical situation that would affect oral absorption
    16. Females who are pregnant; females who plan to breastfeed during study treatment through 90 days after ending treatment
    17. Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results.
    18. Any illness or medical conditions that are unstable or could jeopardize the safety of the subjects and their compliance in the study. Inability to understand and sign informed consent form.
    1. Diagnosi confermata istologicamente di LF di Gr 3b o malattia trasformata
    - Per i soggetti con segni clinici di rapida progressione della malattia (per es. con sintomi B marcati) e indicazione di laboratorio o radiografica (per es. livelli elevati di lattato deidrogenasi o di valore di captazione standardizzato mediante tomografia a emissione di positroni [PET]), si raccomanda una biopsia su tessuto fresco per escludere che la malattia si sia trasformata
    2. Soggetti trattati sia con R/O-B che con R/O-CHOP (o altro regime a base di antraciclina) come precedenti linee di terapia e quelli trattati esclusivamente con terapia a base di mAb anti-CD20 come singolo agente come precedente linea di trattamento
    3. Precedente terapia con inibitori di PI3K
    4. Infiammazione polmonare indotta da farmaco in corso o in anamnesi
    5. Coinvolgimento noto del sistema nervoso centrale da parte del linfoma.
    6. Sieropositività o infezione virale attiva da virus dell’epatite B:
    - Positività all’antigene di superficie dell’epatite B (HBsAg)
    - Negatività a HBsAg, positività ad anticorpi anti-antigene di superficie dell’epatite B (HBs) e/o anti-antigene core dell’epatite B (HBc) e DNA virale rilevabile mediante reazione a catena della polimerasi (PCR)
    [Nota: i soggetti che sono negativi a HBsAg e presentano un risultato negativo alla PCR per il rilevamento del DNA virale sono idonei. Questi soggetti devono essere sottoposti a terapia profilattica per l’epatite, come da standard istituzionali].
    7. Sieropositività nota oppure infezione attiva da virus dell’epatite C.
    - I soggetti con positività agli anticorpi contro il virus dell’epatite C (HCV) sono idonei con negatività al test PCR per l’HCV
    8. Sieropositività nota oppure infezione attiva da virus dell’immunodeficienza umana
    9. Sieropositività nota oppure infezione attiva da virus della leucemia a cellule T umana di tipo 1
    10. Qualsiasi malattia clinicamente significativa, non controllata, comprese, senza pretesa di esaustività, infezioni attive che necessitano di una terapia antimicrobica sistemica, ipertensione, angina, aritmie, malattia polmonare o disfunzione autoimmune
    11. Ipersensibilità o altra reazione clinicamente significativa al farmaco dello studio o ai suoi eccipienti
    12. Procedura chirurgica maggiore nelle 4 settimane precedenti al G1 dello studio (sono ammissibili le procedure chirurgiche minori, per es. biopsia dei linfonodi, eseguita in giornata o con pernottamento)
    13. Tumore precedente o concomitante, diverso in termini di sito primario o istologia da LNH a cellule B indolente, nei 3 anni precedenti all’inizio del trattamento dello studio, fatta eccezione per i seguenti tumori sottoposti a trattamento curativo: carcinoma cervicale in situ, tumore della pelle diverso da melanoma e tumori superficiali della vescica (Ta [tumore non invasivo], Tis [carcinoma in situ] e T1 [il tumore invade la lamina propria]) e tumore della prostata localizzato asintomatico che non necessita di terapia sistemica o che necessita di sola terapia ormonale e con valori normali di antigene prostatico specifico entro >= 12 mesi precedenti alla randomizzazione
    14. Anamnesi di anomalie cardiovascolari clinicamente significative, quali ad esempio insufficienza cardiaca congestizia (punteggio >= II secondo la classificazione della New York Heart Association (NYHA) [NYHA 1994]), infarto del miocardio nei 6 mesi precedenti all’ingresso nello studio.
    15. Anamnesi di disturbi gastrointestinali (GI) clinicamente significativi, in particolare:
    - Disturbo GI noto che interferirebbe con la deglutizione o l’assorbimento orale o la tolleranza al farmaco dello studio
    - Preesistente sindrome da malassorbimento o altro disturbo clinico che potrebbe compromettere l’assorbimento orale
    16. Donne incinte; donne che intendono allattare al seno durante il trattamento dello studio fino a 90 giorni dopo la conclusione del trattamento

    Per tutti gli altri criteri, si prega di fare riferimento al Protocollo
    E.5 End points
    E.5.1Primary end point(s)
    PFS as determined by the IRRC
    PFS, secondo quanto stabilito dall’IRRC
    E.5.1.1Timepoint(s) of evaluation of this end point
    The study duration for primary completion of PFS is approximately 64 months with 36 months enrollment period and 28 months follow-up (after last subject enrolled).
    La durata dello studio per il completamento primario della PFS è di circa 64 mesi, con un periodo di arruolamento di 36 mesi e un follow-up di 28 mesi (dopo l’ultimo soggetto arruolato).
    E.5.2Secondary end point(s)
    - Efficacy: ORR and CRR as determined by the IRRC
    - OS
    - PRO – time to deterioration in the 9-item DRS-P subset of FlymSI-18
    - PRO-change from baseline in EQ-5D total score at specified study visits
    - Treatment-emergent AEs, serious AEs, and laboratory abnormalities
    - Efficacia: ORR e CRR, secondo quanto stabilito dall’IRRC
    - OS
    - PRO – tempo al deterioramento nel sottogruppo del questionario FlymSI-18 relativo ai sintomi fisici correlati alla malattia a 9 voci (DRS-P)
    - Variazione in termini di PRO rispetto al basale del punteggio totale di EQ-5D in occasione delle visite dello studio specificate
    - EA emergenti dal trattamento, EA seri e anomalie di laboratorio
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to study protocol
    Fare riferimento al protocollo dello studio
    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) 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 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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA83
    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
    Argentina
    Australia
    Belgium
    Bulgaria
    Canada
    Czechia
    Finland
    France
    Georgia
    Germany
    Greece
    Hungary
    Ireland
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Poland
    Puerto Rico
    Russian Federation
    Serbia
    Spain
    Sweden
    Switzerland
    Taiwan
    Turkey
    Ukraine
    United Kingdom
    United States
    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
    The study will end when all subjects have been followed for survival, or lost to follow up, or 5 years from the last subject's randomization, whichever comes first
    Lo studio terminerà quando tutti i soggetti avranno completato il follow up di sopravvivenza, o non abbiano partecipato al follow-up o 5 anni dalla randomizzazione dell’ultimo soggetto, a seconda di quale condizione si verifica per prima.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years10
    E.8.9.2In all countries concerned by the trial months8
    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: 267
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 267
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 215
    F.4.2.2In the whole clinical trial 534
    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)
    There are no plans for treatment or care after the subject has ended the participation in the trial
    Non ci sono piani per il trattamento o la cura dopo che il soggetto ha terminato la partecipazione allo studio
    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 Decision2021-06-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-18
    P. End of Trial
    P.End of Trial StatusOngoing
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