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    Summary
    EudraCT Number:2016-005061-31
    Sponsor's Protocol Code Number:GATA
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-09-08
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2016-005061-31
    A.3Full title of the trial
    A PHASE II TRIAL EVALUATING COMBINATION OF ATEZOLIZUMAB, WITH VENETOCLAX AND OBINUTUZUMAB FOR RELAPSED/REFRACTORY LYMPHOMAS
    ETUDE DE PHASE II EVALUANT LA COMBINAISON ATEZOLIZUMAB, AVEC VENETOCLAX ET OBINUTUZUMAB CHEZ DES PATIENTS ATTEINTS DE LYMPHOME EN RECHUTE OU REFRACTAIRE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EVALUATION OF THE COMBINATION OF ATEZOLIZUMAB, WITH VENETOCLAX AND OBINUTUZUMAB FOR RELAPSED/REFRACTORY LYMPHOMAS
    EVALUATION DE LA COMBINAISON ATEZOLIZUMAB-VENETOCLAX- OBINUTUZUMAB CHEZ DES PATIENTS ATTEINTS DE LYMPHOME EN RECHUTE OU REFRACTAIRE
    A.4.1Sponsor's protocol code numberGATA
    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 SponsorLYSARC
    B.1.3.4CountryFrance
    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 supportLaroche-Hoffman
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLYSARC
    B.5.2Functional name of contact pointProject Management - J.Assémat
    B.5.3 Address:
    B.5.3.1Street AddressCHU LYON SUD - PAV 6D
    B.5.3.2Town/ cityPIERRE BENITE
    B.5.3.3Post code69495
    B.5.3.4CountryFrance
    B.5.4Telephone number+33472 66 93 33
    B.5.5Fax number+33426 07 40 55
    B.5.6E-mailgata@lysarc.org
    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 GAZYVARO
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/15/1504
    D.3 Description of the IMP
    D.3.1Product nameobinutuzumab
    D.3.2Product code GA101
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNGA101
    D.3.9.1CAS number 949142-50-1
    D.3.9.3Other descriptive nameOBINUTUZUMAB
    D.3.9.4EV Substance CodeSUB32751
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    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: 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
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/16/1766
    D.3 Description of the IMP
    D.3.1Product namevenetoclax
    D.3.2Product code ABT-199
    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.3.8INN - Proposed INNVENETOCLAX
    D.3.9.2Current sponsor codeABT-199 ( A-1195425.0)
    D.3.9.4EV Substance CodeSUB176260
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 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
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/16/1766
    D.3 Description of the IMP
    D.3.1Product namevenetoclax
    D.3.2Product code ABT-199
    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.3.8INN - Proposed INNVENETOCLAX
    D.3.9.2Current sponsor codeABT-199 ( A-1195425.0)
    D.3.9.4EV Substance CodeSUB176260
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    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 TECENTRIQ
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameatezolizumab
    D.3.2Product code RO5541267
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNATEZOLIZUMAB
    D.3.9.2Current sponsor codeRO-5541267
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product 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/refractory follicular lymphoma (FL) patients
    - relapsed/refractory aggressive (DLBCL) lymphoma patients
    - relapsed/refractory other indolent lymphoma patients
    E.1.1.1Medical condition in easily understood language
    Lymphoma
    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 PT
    E.1.2Classification code 10016906
    E.1.2Term Follicle centre lymphoma, follicular grade I, II, III 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 20.0
    E.1.2Level PT
    E.1.2Classification code 10012822
    E.1.2Term Diffuse large B-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 20.0
    E.1.2Level PT
    E.1.2Classification code 10015824
    E.1.2Term Extranodal marginal zone B-cell lymphoma (MALT type) 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 20.0
    E.1.2Level PT
    E.1.2Classification code 10003912
    E.1.2Term B-cell small lymphocytic 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 20.0
    E.1.2Level PT
    E.1.2Classification code 10003903
    E.1.2Term B-cell lymphoma refractory
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to assess the anti-lymphoma activity of an anti-PD-L1 (atezolizumab) associated with a BCL-2 inhibitor (GDC-199, venetoclax) and an anti-CD20 monoclonal antibody (obinutuzumab) in three separate cohorts:
    - relapsed/refractory follicular lymphoma (FL) patients
    - relapsed/refractory aggressive (DLBCL) lymphoma patients
    - relapsed/refractory other indolent lymphoma patients
    E.2.2Secondary objectives of the trial
    - to evaluate safety and tolerability of atezolizumab+ venetoclax+obinutuzumab for relapsed/refractory B-cell lymphomas
    - to assess the efficacy of the combination of obinutuzumab+ atezolizumab+venetoclax
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically documented CD20-positive follicular lymphoma (WHO grade 1, 2, or 3a) patients

    OR
    - patients with either histologically documented CD20-positive Diffuse large-cell lymphoma (including transformations of low-grade lymphoma into DLBCL) or follicular lymphoma CD20+ grade 3b, or primary cutaneous DLBCL leg type, or primary mediastinal (thymic) large B-cell lymphoma, or high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, or unclassifiable B-cell lymphoma with features intermediate between DLBCL and Hodgkin (WHO classification)

    OR
    - Relapsed/refractory indolent lymphoma (marginal zone (MZL) or lymphocytic lymphoma (LL) or measurable mucosa-associated lymphoid tissue (MALT) lymphoma)

    - Relapsed/refractory NHL after ≥1 prior R-containing regimen with no curative option
    - Aged 18 years or more with no upper age limit
    - ECOG performance status 0, 1 or 2
    - Bi-dimensionally measurable disease defined by at least one single node or tumor lesion > 1.5 cm assessed by CT scan, or PET scan without IV contrast at diagnosis with at least one
    hypermetabolic lesion
    - Life expectancy ≥ 3 months
    E.4Principal exclusion criteria
    - indolent lymphoma, waldenström macroglobulinemia, unmeasurable MALT lymphoma, and Mantle Cell Lymphoma (MCL) lymphoma
    - known CD20 negative status at last biopsy done (Biopsy at relapse/progression is mandatory)
    - central nervous system or meningeal involvement by lymphoma
    - prior history of Progressive Multifocal Leukoencephalopathy (PML)
    - documented infection with HIV
    - active hepatitis B OR positive serology to hepatitis B
    - active hepatitis C infection
    - known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds)
    - active immune-related disease criteria
    - LVEF < 45% as determined by echocardiography or multiple uptake gated acquisition (MUGA) scan
    - any serious active disease or co-morbid medical condition
    - clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
    - any of the following laboratory abnormalities unless secondary to underlying lymphoma:
    - Hemoglobin < 9 g/dL
    - Absolute neutrophil count (ANC) < 1,000 cells/mm3 (1.0 G/L) unless due to lymphoma
    - Platelet count < 75,000/mm3 (75 x 109/L) unless due to lymphoma
    - Serum SGOT/AST or SGPT/ALT 3.0 x upper limit of normal (ULN) unless disease involvement
    - Serum total bilirubin > 2.0 mg/dL (34 µmol/L), except if disease related or in case of Gilbert syndrome
    - Calculated creatinine clearance (Cockcroft-Gault formula or MDRD) of < 50 mL /min
    - International normalized ratio (INR) ≤ 1.5 x ULN for patients not receiving therapeutic anticoagulation
    - Partial thromboplastin time (PTT) or activated PTT (aPTT) > 1.5 x ULN
    - Prior history of malignancies other than lymphoma unless the subject has been free of the disease for ≥ 3 years. Excepted non-melanoma skin tumors or any surgically removed stage 0 (in situ) carcinoma
    - contraindication to any drug contained in the study treatment regimen
    - previous treatment with obinutuzumab, atezolizumab or venetoclax
    - use of any standard or experimental anti-cancer drug therapy within 28 days prior to first administration of study drug
    - use of warfarin prior to first administration of study drug and throughout all treatment period
    - corticosteroids within 4 weeks prior to first administration of study drug, unless administered at a cumulated dose equivalent to ≤ 3.5mg/kg (within these 4 weeks).
    - use of the following agents prior to first administration of study drug:
    - strong and moderate CYP3A inhibitors (including grapefruit juice)
    - strong and moderate CYP3A inducers
    E.5 End points
    E.5.1Primary end point(s)
    Overall Metabolic Response Rate (OMRR) according to Lugano 2014 response criteria
    E.5.1.1Timepoint(s) of evaluation of this end point
    end of induction = 8 cycles of obinutuzumab, atezolizumab and venetoclax or at premature treatment discontinuation (if patient did not complete 8 cycles)
    E.5.2Secondary end point(s)
    - number of SAE
    - Progression Free Survival (PFS)
    - Overall Survival (OS)
    - Duration of Response (DoR)
    - Overall Metabolic Response Rate (OMRR)
    - Best Response (BR)
    - Long-term safety (second cancer, immune-related disease)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - number of SAE = 28 days after end of treatment (EOT)
    - Progression Free Survival (PFS) = end of study
    - Overall Survival (OS) = end of study
    - Duration of Response (DoR) = end of study
    - Overall Metabolic Response Rate (OMRR)
    - after 4 and 8 cycles according to LYRIC (LYmphoma Response to Immunomodulatory therapy Criteria)
    - after 4 cycles (M3) and at EOT (M18) according to Lugano 2014 response criteria
    - Best Response (BR) = end of study
    - Long-term safety (second cancer, immune-related disease) = end of study

    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned25
    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 No
    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
    LVLP
    patients will be followed until the last patient included will have been followed up for one year after his last intake of study medication
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 38
    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 state138
    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)
    same than the expected normal treatment of that condition = defined by the patient's physician
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation LYSA
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-08-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-08-24
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