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    Summary
    EudraCT Number:2011-005150-62
    Sponsor's Protocol Code Number:GALEN
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-05-21
    Trial results View 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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2011-005150-62
    A.3Full title of the trial
    A Phase Ib/II study of OBINUTUZUMAB combined with LENALIDOMIDE for the treatment of relapsed/refractory follicular and Aggressive (DLBCL and MCL) B-cell Lymphoma.
    Etude de phase Ib/II de l’Obinutuzumab (GA101) combiné au lenalidomide pour le traitement du lymphome folliculaire et du lymphome agressif à cellules B (DLBCL et MCL) réfractaire ou en rechute.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to determine the recommended dose, the safety and the efficacy of lenalidomide administered in association with obinutuzumab (GA101) for the treatment of relapsed/refractory B-cell Lymphoma.
    Etude pour déterminer la dose recommandée, la tolérance et l'efficacité du lenalidomide administré en association avec l'obinutuzumab (GA101) pour le traitement du lymphome à cellules B réfractaire ou en rechute.
    A.3.2Name or abbreviated title of the trial where available
    GALEN
    A.4.1Sponsor's protocol code numberGALEN
    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 supportCELGENE International Sàrl
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportF.Hoffmann-la Roche Ltd.
    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 pointAnne VIOLA
    B.5.3 Address:
    B.5.3.1Street AddressLYSARC - Centre Hopistalier Lyon Sud - Bât 2D
    B.5.3.2Town/ cityPIERRE BENITE Cedex
    B.5.3.3Post code69495
    B.5.3.4CountryFrance
    B.5.4Telephone number33472669333
    B.5.5Fax number33426074055
    B.5.6E-mailaffaires-reglementaires@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 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 nameObinutuzumab
    D.3.2Product code RO 5072759 / GA101
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNObinutuzumab
    D.3.9.1CAS number 949142-50-1
    D.3.9.2Current sponsor codeGA101
    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 Revlimid 5mg hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe 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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLenalidomide
    D.3.2Product code CC-5013
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.3Other descriptive nameSUB25389
    D.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Revlimid 10mg hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe 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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namelenalidomide
    D.3.2Product code CC-5013
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.3Other descriptive nameSUB25389
    D.3.9.4EV Substance CodeSUB25389
    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 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 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 name89Zr-Obinutuzumab
    D.3.2Product code 89Zr-GA101
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INN89Zr-obinutuzumab
    D.3.9.1CAS number 949142-50-1
    D.3.9.2Current sponsor code89Zr-GA101
    D.3.9.3Other descriptive nameOBINUTUZUMAB
    D.3.9.4EV Substance CodeSUB32751
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.7
    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 Yes
    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.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
    Phase IB: CD20 positive Follicular Lymphoma, WHO grade 1, 2 or 3a relapsed/refractory after ≥1 prior R-containing regimen
    Phase II:
    - CD20 positive follicular not previously treated
    - CD20 positive follicular relapsed/refractory after ≥1 prior R-containing regimen
    - agressive B-cell lymphoma (Diffuse Large B-Cell Lymphoma and Mantle Cell Lymphoma) relapsed/refractory after ≥1 prior R-containing regimen
    Phase IB: lymphome folliculaire CD20 positif grade 1 à 3a réfractaire ou en rechute après ≥1 ligne de chimiothérapie contenant du rituximab
    Phase II:
    - lymphome folliculaire CD20 positif non préalablement traité
    - lymphome folliculaire CD20 positif réfractaire ou en rechute
    - lymphome à cellules B agressif (Lymphome B diffus à grandes cellules et lymphome du manteau) réfractaire ou en rechute (réfractaire ou en rechute = après ≥1 ligne de chimiothérapie contenant du rituximab)
    E.1.1.1Medical condition in easily understood language
    Phase I: follicular lymphoma relapsed after ≥1 regimen
    Phase II:
    - follicular lymphoma not previously treated or relapsed after ≥1 regimen
    - agressive lymhoma relapsed after ≥1 regimen
    Phase IB: lymphome folliculaire en rechute après ≥1 chimiothérapie
    Phase II: - lymphome folliculaire non traité ou en rechute ≥1 traitement
    - lymphome à cellules B agressif en rechute ≥1 traitement
    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 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 21.0
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10026801
    E.1.2Term Mantle 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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase IB: to determine the recommended dose (RD) of lenalinomide (Revlimid) when administered in association with obinutuzumab by
    escalation approach (3+3 dosing).
    Phase II: to assess the efficacy of the association of the recommended dose of lenalidomide in combination with obinutuzumab, as measured by the response rate (ORR/CR/CRu) at the end of 6 cycles in 2 different populations of patients with relapsed/refractory disease: follicular lymphoma and aggressive lymphoma [aNHL] (Diffuse large B-cell and Mantle cell lymphoma).
    E.2.2Secondary objectives of the trial
    - To assess the safety of the combination of lenalidomide plus obinutuzumab during induction and maintenance therapy by monitoring
    all adverse and serious adverse events AEs/SAEs according to the NCICTCAE v. 4.
    - To assess the efficacy of the combination of lenalidomide plus obinutuzumab: Complete response (CR) rate after 3 and 6 cycles, for
    patients who received maintenance treatment OR and CR rate at the end of maintenance treatment, best overall response rate (BOR), event free survival (EFS), progression free survival (PFS), response duration (RD) and overall survival (OS) according to Cheson 1999 and 2007
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1- A optionnal biological study is planned for 60 patients included in the study. This biological program includes phenotypic, plasmatic and functional analysis.
    2- GALEN-IM
    Immuno-PET with 89Zr-obinutuzumab : a sub-study during the first two cycles of the GALEN Phase Ib/II study of obinutuzumab (GA101) combined with Lenalidomide for the treatment of relapsed/refractory Bcell lymphoma
    The GALEN-IM study is an open-label, multicentre exploratory immunoPET ancillary study conducted in a subset of 30 patients included in GALEN study with follicular lymphoma. These patients will receive 89Zr-obinutuzumab intravenously in 5 minutes, in addition to the dose of GALEN obinutuzumab, on Cycle 1 D8 or Cycle 2 D1.
    Primary Objectives
    - To determine the tissue concentration of obinutuzumab in the tumour after the first (C1D8) and the fourth infusion (C2D1) of 1000 mg obinutuzumab by measuring the concentration of 89Zr-obinutuzumab at different time points in the tumour using PET.
    - To determine the tissue concentration of obinutuzumab in the main organs of interest (liver, spleen, kidneys, lungs, bone marrow) after the first infusion and the fourth infusion of 1000 mg obinutuzumab by measuring the concentration of 89Zr-obinutuzumab at different time points in these different organs using PET.
    - To generate a PK model for obinutuzumab combining quantitative imaging in body tissues (89Zr-obinutuzumab uptake) and sequential blood PK sampling (both labelled and cold obinutuzumab).
    Secondary objectives
    - The secondary objectives of GALEN-IM substudy are:
    - To define the radiation exposure to individuals subject to immunoPET with 89Zr-obinutuzumab.
    - To compare the concentration-time profiles of obinutuzumab in the tumour and normal organs after the first infusion and the fourth infusion of obinutuzumab.
    - To correlate the tissue and plasma PK with total tumour burden
    - To evaluate the pattern of 89Zr-obinutuzumab uptake within and inbetween lesions with the pattern of FDG uptake in lymphoma tissue and the tumour volume based on CT scan.
    Exploratory objectives
    - The exploratory objectives of GALEN-IM substudy are:
    - To correlate patterns of concentration-time profiles of obinutuzumab in the tumour after the first and fourth infusion of obinutuzumab to overall
    and complete response rates and survival parameters.
    -To correlate the tumour assessments by immunoPET, FDG and volume CT after the first and fourth infusion of Obinutuzumab to overall and complete response rates and survival parameters.
    E.3Principal inclusion criteria
    Phase IB only: Histologically documented CD20-positive follicular lymphoma (WHO grade 1, 2, or 3a) patients

    Phase II only: patients with either histologically documented CD20- positive Diffuse large-cell lymphoma or Mantle cell lymphoma (cohort 1) or follicular lymphoma, WHO grade 1, 2 or 3a (cohort 2)

    Phase IB and II:
    - Not previoulsy treated follicular lymphoma or relapsed/refractory NHL after ≥1 prior R-containing regimen with no curative option
    - Aged 18 years or more
    - ECOG performance status 0, 1 or 2
    - At least one bi-dimensionally measurable nodal or tumor lesion defined by CT scan as: greatest transverse diameter > 1.5 cm and a short axis ≥ 10mm
    - Signed inform consent
    - Life expectancy of ≥ 3 months
    - All subjects must be able to understand and fulfill the lenalidomide
    Pregnancy Prevention Plan requirements
    - Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; 3) dose interruptions; and 4) for at least 18 months after discontinuation of all study treatments.
    E.4Principal exclusion criteria
    - Previous treatment with obinutuzumab or lenalidomide
    - Known CD20 negative status at relapse/progression. Biopsy at relapse/progression is recommended but not mandatory
    - Central nervous system or meningeal involvement by lymphoma
    - Contraindication to any drug contained in the study treatment regimen
    - Known HIV or HTLV-1 infection, positive serology to HB surface antigen [HBsAg] or total HB core antibody [anti-HB-c]) and Hepatitis C (Hepatitis C virus [HCV] antibody)
    - Any serious active disease or co-morbid medical condition (such as New York Heart Association Class III or IV cardiac disease, severe arrhythmia, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm or other according to investigator's decision)
    - Any of the following laboratory abnormalities.
    o Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L)
    o Platelet count < 100,000/mm3 (100 x 109/L) unless due to lymphoma for phase II part.
    o Serum SGOT/AST or SGPT/ALT 3.0 x upper limit of normal (ULN) unless disease involvement.
    o 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. For phase II part of the study, patients with calculated creatinine clearance between 30 and 50ml/min can be included and lenalidomide dose will be adjusted as follows (10mg once daily).
    - Prior history of malignancies other than lymphoma unless the subject has been free of the disease for ≥ 5 years. During phase Ib, exceptions will be allowed for patients with of non-melanoma skin tumors (basal cell or squamous cell carcinoma of the skin) or any surgically removed stage 0 (in situ) carcinoma.
    - Any serious medical condition, laboratory abnormality (other than mentioned above), or psychiatric illness that would prevent the subject from signing the informed consent form.
    - Pregnant or lactating females.
    - Prior ≥ Grade 3 allergic reaction/hypersensitivity to thalidomide.
    - Prior ≥ Grade 3 rash or any desquamating (blistering) rash while taking thalidomide.
    - Subjects with ≥ Grade 2 neuropathy.
    - Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation (Day 1) of study drug therapy
    - Patients taking corticosteroids during 4 weeks before inclusion, unless administered at a dose equivalent to ≤ 10 mg/day prednisone (over these 4 weeks).
    - Prior history of Progressive Multifocal Leukoencephalopathy (PML)
    E.5 End points
    E.5.1Primary end point(s)
    Phase IB: the determination of the recommended dose (RD) of lenalidomide in combination with fixed doses of GA101 by a dose escalation approach (3+3design).
    Phase II: the efficacy of the recommended dose of lenalidomide in combination with GA101 will be measured by the overall response rate ORR by IWG criteria (Cheson 1999) at the end of 6 cycles in 2 different populations of patients with relapsed/refractory disease: follicular lymphoma and aggressive lymphoma [aNHL] (Diffuse large B-cell and Mantle cell lymphoma)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase I: at the end of cycle 1 (after 28 days)
    Phase II: at the end of cycle 6 (after 6 months)
    E.5.2Secondary end point(s)
    - Safety of study treatment will be evaluated during induction and maintenance by monitoring all adverse and serious adverse events AEs/SAEs according to the NCI-CTCAE v. 4.
    - Efficacy will be evaluated by CR rate after 3 and 6 cycles, OR and CR rate at the end of maintenance treatment, BOR, EFS, PFS, RD and OS.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - All adverse events will be reported during the study period up to 28 days after the last drug administration regardless the relationship with study drug and after this period if the event is related to the study drug
    - after 3 and 6 cycles (after 3 and 6 months)
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Determination of the recommended dose of lenalidomide in combination with GA101
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    last visit of the last subject
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 148
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 291
    F.4.2.2In the whole clinical trial 291
    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)
    Patients will be treated according to local practice
    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 Decision2013-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-05-20
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