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    Summary
    EudraCT Number:2018-001777-25
    Sponsor's Protocol Code Number:FILOCLL09-IDA53
    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:2018-08-21
    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 number2018-001777-25
    A.3Full title of the trial
    A Phase II Pilot Study to Evaluate the Safety and Efficacy of the association of Ibrutinib and Daratumumab in Relapsed/Refractory Chronic Lymphocytic Leukemia with p53 dysfunction. IDA53 trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II Pilot Study to Evaluate the Safety and Efficacy of the association of Ibrutinib and Daratumumab in Relapsed/Refractory Chronic Lymphocytic Leukemia with p53 dysfunction. IDA53 trial
    A.3.2Name or abbreviated title of the trial where available
    FILOCLL09-IDA53
    A.4.1Sponsor's protocol code numberFILOCLL09-IDA53
    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 SponsorFILO
    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 supportJANSSEN
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFILO
    B.5.2Functional name of contact pointAUVRAY Laetitia
    B.5.3 Address:
    B.5.3.1Street AddressCHRU Tours – Hôpital Bretonneau
    B.5.3.2Town/ cityTOURS
    B.5.3.3Post code37044
    B.5.3.4CountryFrance
    B.5.4Telephone number330247 39 18 96
    B.5.5Fax number330247 37 35 12
    B.5.6E-mails.roy.filo@gmail.com
    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 DARZALEX
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN
    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.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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 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 IMBRUVICA
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN
    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.3.4Pharmaceutical form Capsule
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsed/Refractory Chronic Lymphocytic Leukemia with p53 dysfunction.
    E.1.1.1Medical condition in easily understood language
    Relapsed/Refractory Chronic Lymphocytic Leukemia with p53 dysfunction.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the efficacy of a treatment combining daratumumab and ibrutinib in a poor risk population of relapsed CLL patients with TP53 dysfunction.
    E.2.2Secondary objectives of the trial
    To determine the safety profile of daratumumab in combination with ibrutinib in CLL patients
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Immunophenotypically confirmed diagnosis of CLL (2008 iwCLL criteria)
    • Progressive CLL according to iwCLL criteria
    • Relapsed or refractory disease (≥ 1 previous line of treatment) with P53 genetic alteration (17p deletion and/or TP53 mutation)
    • ECOG status 0-2
    • Age > 18 years
    • Negative serum pregnancy test one week prior to treatment for premenopausal women
    • CIRS (Cumulative Illness Rating Scale) ≤6
    • Life expectancy > 3 months
    • Possibility of follow-up
    • Ability to understand the protocol
    • Written informed consent of patient and treating physician
    E.4Principal exclusion criteria
    • Previous treatment with ibrutinib.
    • Patient refusal to perform bone marrow biopsy for evaluation point
    • Prior other malignancy (except for adequately treated basal cell or squamous cell skin cancer, in situ cancer, or other cancer from which the subject has been disease free for ≥ 2 years).
    • Known chronic obstructive pulmonary disease (COPD) with a Forced Expiratory Volume in 1 second (FEV1) < 50 % of predicted normal. FEV testing is required for patients suspected of having COPD.
    • Moderate or severe persistent asthma within the two last years or currently uncontrolled asthma of any classification (American Lung Association criteria). Current controlled intermittent asthma or controlled mild persistent asthma is not an exclusion criterion.
    • Patients with active bacterial, viral, or fungal infection requiring systemic treatment.
    • Patients with known infection with human immunodeficiency virus (HIV) or HTLV-1
    • Active B or C hepatitis (positive HBsAg or HBV DNA for HBV; Positive HCV RNA for HCV)
    • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
    • Any other uncontrolled medical condition or comorbidity that might interfere with subject’s participation.
    • Concomitant dual antiplatelet therapy
    • Concomitant treatment with both antiplatelet and anticoagulation therapy
    • Treatment with other investigational agent or participating to another trial within 30 days prior to entering the study
    • Hemoglobin < 8 g/dL
    • Absolute neutrophil count (ANC) < 1000/mm^3
    • Platelets < 30,000/mm^3
    • Inadequate renal function: creatinine clearance < 50 ml/min (Cockroft and Gault)
    • Inadequate liver function: AST, ALT > 2.5 x ULN
    • Total bilirubin >1.5 x ULN unless rise is due to Gilbert’s syndrome or of non- hepatic origin.
    • Active auto-immune haemolytic anemia
    • Richter’s transformation
    • Evidence of central nervous system (CNS) involvement
    • Pregnant or breastfeeding women.
    • Adult under law-control
    • Fertile male and female patients who cannot or do not wish to use an effective method of contraception, during and for 12 months after the final treatment used for the purposes of the study
    • No afiliate to social security
    E.5 End points
    E.5.1Primary end point(s)
    CR rate at 12 months
    E.5.1.1Timepoint(s) of evaluation of this end point
    M12
    E.5.2Secondary end point(s)
    • Frequency and severity of tumor lysis syndrome during and after the 2 first infusions of daratumumab
    • Type, frequency, severity and relationship to study treatment of adverse events. Incidence of Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE) and laboratory abnormalities using National Cancer Institute (NCI) common toxicity criteria (CCTAE V4)
    • OR rate, PR rate, PR with lymphocytosis rate
    • MRD assessement
    • PFS and OS
    • Duration of response
    • Time to next treatment
    • Cumulative rate of Richter’s syndrome
    • CD38 expression in CLL cells before treatment and on ibrutinib before daratumumab initiation
    • Ancillary studies
    E.5.2.1Timepoint(s) of evaluation of this end point
    until the last patient has definitively stopped study treatment
    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.8.2.4Number 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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 state44
    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)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-02
    P. End of Trial
    P.End of Trial StatusCompleted
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