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    Summary
    EudraCT Number:2015-001487-19
    Sponsor's Protocol Code Number:35/14
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-04-06
    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 ConcernedNorway - NOMA
    A.2EudraCT number2015-001487-19
    A.3Full title of the trial
    Rituximab with or without Ibrutinib for untreated patients with advanced follicular lymphoma in need of therapy.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Rituximab with or without Ibrutinib for untreated patients with advanced follicular lymphoma in need of therapy.
    A.3.2Name or abbreviated title of the trial where available
    Protocol SAKK 35/14
    A.4.1Sponsor's protocol code number35/14
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02451111
    A.5.4Other Identifiers
    Name:SNCTP NoNumber:SNCTP000001327
    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 SponsorSwiss Group For Clinical Cancer Research (SAKK)
    B.1.3.4CountrySwitzerland
    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 supportSwiss Group For Clinical Cancer Research (SAKK)
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportJanssen Cilag AG
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSwiss Group For Clinical Cancer Research (SAKK)
    B.5.2Functional name of contact pointSabina Rion
    B.5.3 Address:
    B.5.3.1Street AddressEffingerstrasse 40
    B.5.3.2Town/ cityBern
    B.5.3.3Post codeCH - 3008
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number41313899204
    B.5.5Fax number41313899200
    B.5.6E-mailsabine.rion@sakk.ch
    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 Imbruvica
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameImbruvica
    D.3.2Product code L01X E27
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Follicular Lymphoma (FL), advanced disease in need of therapy
    E.1.1.1Medical condition in easily understood language
    This trial is targeting patients with advanced follicular lymphoma in need of therapy. These patients could avoid an eventually unnecessary and toxic chemotherapy treatment.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this trial is to study the activity and the safety of the 1st line treatment with Ibrutinib in combination with Rituximab for patients with advanced follicular lymphoma in need of therapy.
    E.2.2Secondary objectives of the trial
    Secondary endpoints of the trial are:
     CR at 30 months determined by PET/CT scan by the IRR panel
     MRD evaluation
     Overall response (OR) at 24 weeks
     Duration of complete response (DUR)
     Progression-free survival (PFS)
     Event-free survival (EFS)
     Time to next anti-lymphoma therapy (TTNT)
     Overall survival (OS)
     Adverse Events (AEs)
     Exploratory endpoints
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    6.1.1 Written informed consent according to ICH/GCP guidelines
    6.1.2 Histologically confirmed FL CD20+; grade 1, 2, 3a; stage III+IV; stage II not suitable for radiotherapy; all FLIPI
    6.1.3 Tumor specimens (slides or block) available for pathological review
    6.1.4 In need of systemic therapy (at least one of the following indications must be fulfilled):
     Symptomatic disease
     Bulky disease (≥ 6 cm)
     Steady, clinically significant progression over at least 6 months of any tumor lesion
     B-symptoms (weight loss > 10% in 6 months, drenching night sweats, fever > 38°C not due to infection)
     Anemia (hemoglobin < 100 g/L) or thrombocytopenia (platelets 50-100 x 109/L) due to lymphoma
    6.1.5 At least one two-dimensionally measurable lesion with a longest diameter (LDi) ≥ 15 mm in contrast-enhanced 18F-FDG PET/CT* scan
    6.1.6 FDG-avid tumor lesion in contrast-enhanced 18F-FDG PET/CT* scan
    6.1.7 Age 18-85 years
    6.1.8 WHO performance status 0-2 (see Appendix 6)
    6.1.9 Adequate bone marrow function:
     Absolute neutrophil count (ANC) > 1.0 x 109/L independent of growth factor support
     Platelets ≥ 100 x 109/L or ≥ 50 x 109/L if bone marrow involvement independent of transfusion support in either situation
    6.1.10 Adequate hepatic function:
     Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN)
     Total bilirubin ≤ 1.5 x ULN unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin
    6.1.11 Adequate renal function:
     Serum creatinine ≤ 2 x ULN and corrected calculated creatinine clearance ≥ 40 mL/min/1.73m2.
    6.1.12 Women of childbearing potential have a negative serum (beta-human chorionic gonadotropin [-hCG]) or urine pregnancy test at Screening.
    6.1.13 Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. Men must agree to not donate sperm during and after the study. For females and males, these restrictions apply for 12 months after the last dose of study drug.
    6.1.14 Patient compliance and geographic proximity allow proper staging and follow-up.
    E.4Principal exclusion criteria
    6.2.1 Tumor bulk requiring fast response
    6.2.2 Known central nervous system lymphoma
    6.2.3 Previous systemic FL therapies
    6.2.4 Major surgery 4 weeks prior to randomization
    6.2.5 Previous or concomitant malignancy diagnosed within 3 years with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer
    6.2.6 History of stroke or intracranial hemorrhage within 6 months prior to randomization
    6.2.7 Clinically significant cardiovascular diseases such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
    6.2.8 Known history of human immunodeficiency virus (HIV) or active Hepatitis C Virus or active Hepatitis B Virus infection or any uncontrolled active systemic infection requiring intravenous (i.v.) antibiotics
    6.2.9 Concomitant diseases that require anticoagulation with warfarin or equivalent vitamin K antagonists (eg. phenprocoumon), factor Xa inhibitors (e.g. rivaroxaban, apixaban), direct thrombin inhibitors (e.g. dabigatran) or platelet inhibitors
    6.2.10 Concomitant diseases that require treatment with strong or moderate CYP3A inhibitors (see http://medicine.iupui.edu and also chapter 9)
    6.2.11 Any concomitant drugs contraindicated for use with the trial drugs according to the approved product information or known hypersensitivity to trial drugs
    6.2.12 Concurrent treatment with other experimental drugs or other anticancer therapy, treatment in a clinical trial within 30 days prior to trial entry
    6.2.13 Vaccinated with live, attenuated vaccines 4 weeks prior to randomization
    6.2.14 Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of Ibrutinib capsules, or put the study outcomes at undue risk
    6.2.15 Psychiatric disorder precluding understanding information of trial related topics, giving informed consent or interfering with compliance for oral drug intake
    6.2.16 Women who are pregnant or breastfeeding
    6.2.17 Patients regularly taking corticosteroids during the last 4 weeks, unless administered at a dose equivalent to Prednisone ≤ 15 mg/day for indications other than lymphoma or lymphoma-related symptoms
    E.5 End points
    E.5.1Primary end point(s)
    Complete Response (CR) at 24 months determined by PET/CT scan by the IRR panel
    The evaluation of CR is outlined in Appendix 1. Any assessment within a window of week 102 to week 118 (inclusive) will be considered as the 24 months response assessment for determining the CR status.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months
    E.5.2Secondary end point(s)
    Secondary endpoints:
     CR at 30 months determined by PET/CT scan by the IRR panel
     MRD evaluation
     Overall response (OR) at 24 weeks
     Duration of complete response
     Progression-free survival (PFS)
     Event-free survival (EFS)
     Time to next anti-lymphoma therapy (TTNT)
     Overall survival (OS)
     Adverse Events (AEs)
     Exploratory endpoints
    E.5.2.1Timepoint(s) of evaluation of this end point
    CR at 30 months (week 126 to 142 will be considered as 30 months)
     MRD evaluation: baseline and week 106
     Overall response (OR) at 24 weeks
     Duration of complete response
     Progression-free survival (PFS)
     Event-free survival (EFS)
     Time to next anti-lymphoma therapy (TTNT)
     Overall survival (OS)
    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 No
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    End of trial is defined as "last visit of the last subject undergoing the trial"
    End of trial treatment is expected for Q4 2019.
    Afterwards, in the following 10 years, information on survival, disease status and further treatment may be collected upon request of SAKK without scheduled trial visits. Overall collection of patient data may last 20 years.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years20
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years20
    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: 95
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 95
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 190
    F.4.2.2In the whole clinical trial 190
    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)
    Standard of care treatment
    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 Decision2016-04-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-17
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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