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    EudraCT Number:2016-001058-16
    Sponsor's Protocol Code Number:NLG-LBC-07
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-09-28
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2016-001058-16
    A.3Full title of the trial
    A Phase II Trial of Idelalisib in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II Trial of Idelalisib in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma.
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberNLG-LBC-07
    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 SponsorNordic Lymphoma Group
    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 supportSkåne University Hospital, Department of Oncology
    B.4.1Name of organisation providing supportGilead
    B.4.1Name of organisation providing supportNordic Lymphoma Group
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSkåne University Hospital, Department of Oncology
    B.5.2Functional name of contact pointKarin Fjordén
    B.5.3 Address:
    B.5.3.1Street AddressGetingevägen 4
    B.5.3.2Town/ cityLund
    B.5.3.3Post code221 85
    B.5.4Telephone number+464617 75 20
    B.5.5Fax number+464617 60 23
    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. name Zydelig
    D. of the Marketing Authorisation holderGilead Sciences International Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameZydelig
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIDELALISIB
    D.3.9.1CAS number 870281-82-6
    D.3.9.4EV Substance CodeSUB126168
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100 to 150
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 diffuse large B-cell lymphoma, including transformed low grade lymphoma.
    E.1.1.1Medical condition in easily understood language
    Relapsed/refractory diffuse large B-cell lymphoma, including transformed low grade lymphoma.
    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 20.0
    E.1.2Level HLT
    E.1.2Classification code 10012819
    E.1.2Term Diffuse large B-cell lymphomas
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of idelalisib in patients with relapsed/refractory diffuse large B-cell lymphoma.
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy od idelalisib in relapsed/refractory diffuse large B-cell lymphoma in term of overall response rate in relation to cell-of-origin
    and specific mutations.
    - To evaluate the efficacy of idelalisib in diffuse large B-cell lymphoma in terms of progression-free survival, complete remission rate, response
    duration and overall survival.
    - To evaluate safety of idelalisib in diffuse large B-cell lymphoma.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age >18 years.
    2. Histologically confirmed diffuse large B-cell lymphoma (DLBCL) , including transformed low grade lymphoma, with either:
    a. Refractory disease: defined as disease progression while receiving their most recent prior cytotoxic chemotherapy
    (single-agent immunotherapy as maintenance is not considered cytotoxic therapy).
    b. Persistent disease: defined as stable disease or partial response at the completion of their most recent prior cytotoxic chemotherapy.
    c. Relapsed/recurrent disease: defined as complete response at the end of their most recent prior cytotoxic chemotherapy with
    subsequent relapse or disease recurrence.
    3. Subjects must have received prior rituximab and may have received up to 5 prior regimens containing cytotoxic chemotherapies.
    4. Subjects must not be candidates for high-dose chemotherapy with autologous stem cell support (ASCT), due to one or more of
    the following factors: relapse after high dose chemotherapy, age, comorbid disease, performance status, or persisting toxicities from prior
    5. Absolute neutrophil count (ANC) >1.0 x 109/L, unless related to bone marrow infiltration.
    6. At least 1 measurable disease lesion that is >1.0 cm in 2 perpendicular dimensions, with the product diameter >2.25 cm2 by
    computed tomography (CT) or magnetic resonance imaging (MRI).
    7. Negative serum pregnancy test within 1 week before first treatment if the subject is a woman of childbearing potential. A woman
    of childbearing potential is defined as one who is biologically capable of becoming pregnant.
    8. WHO performance status 0 – 3.
    9. Written informed consent.
    E.4Principal exclusion criteria
    1. Prior allogeneic hematopoietic stem cell transplant (HSCT).
    2. Prior treatment with PI3K inhibitors.
    3. Serum total bilirubin ≥ 1.5 x ULN (unless elevated due to Gilbert’s syndrome).
    4. Serum ALT and AST ˃ 2.5 x ULN.
    5. Estimated Creatinine Clearance < 10 ml/min.
    6. Known seropositivity for human immunodeficiency virus (HIV).
    7. Known history of drug induced liver injury, chronic active hepatitis C (HCV), chronic active hepatitis B (HBV), alcoholic liver disease,
    non- alcoholic steatohepatitis, primary biliary cirrhosis, on-going extra-hepatic obstruction caused by cholelithiasis, cirrhosis of the liver
    or portal hypertension.
    8. Known history of drug induced pneumonitis.
    9. On-going inflammatory bowel disease.
    10. Evidence of serious active infection (eg, requiring an intravenous [IV] antibiotic, antiviral, or antifungal agent), or subjects with a
    recent history of deep tissue infections such as fascitis or osteomyelitis.
    11. Chemotherapy, cancer immunosuppressive therapy, growth factors (except erythropoietin), or investigational drugs/devices
    <10 days before first dose of investigational product in this study. Subjects receiving high doses of corticosteroids must have been
    tapered to a stable dose
    at least 7 days before the first dose of investigational product.
    12. Pregnant or breastfeeding women.
    13. Symptomatic central nervous system (CNS) NHL; a lumbar puncture is not required unless CNS involvement with NHL is clinically suspected.
    14. Unstable or severe uncontrolled medical condition (eg, unstable cardiac function, unstable pulmonary condition).
    15. Concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix. Subjects with previous
    malignancies are eligible provided that they have been disease free for >2 years.
    16. Previous myocardial infarction or pulmonary hypertension <6 months before first dose of investigational product.
    17. History of clinically significant ventricular arrhythmia, prolonged QTc interval or unexplained syncope.
    18. Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study.
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate for the Germinal Center B-cell (GCB) subtype of diffuse large B-cell lymphoma.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Respons is evaluated at week week 8, week 16, week 24, week 36, week 48, week 60, week 72, week 84, week 96 and at week 108.
    E.5.2Secondary end point(s)
    1. Overall response rate (ORR) for the non-GCB subtype of diffuse large B-cell lymphoma.
    2. Progression-free survival
    3. Complete remission rate
    4. Response duration
    5. Overall survival
    6. Evaluation of specific mutations affecting pathways downstream of B-cell receptor signalling (including CD79a, CD79b, MYD88, CARD11)
    as possible biomarkers for efficacy
    7. Toxicity
    8. Health‐related quality of Life
    E.5.2.1Timepoint(s) of evaluation of this end point
    Toxicity and overall survival is evaluated continously during study treatment.
    Quality of live is evaluated at baseline, week 16, week 36, and at week 72.
    Respons is evaluated at week 8, week 16, week 24, week 36, week 48, week 60, week 72, week 84, week 96 and at week 108.
    Biomarkers for efficacy will be analysed partly during the study, and also after study end.
    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. 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.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    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: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 48
    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 72
    F.4.2.2In the whole clinical trial 72
    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)
    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 Nordic Lymphoma Group
    G.4.3.4Network Country Denmark
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-09-30
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