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    Summary
    EudraCT Number:2014-005299-26
    Sponsor's Protocol Code Number:54767414LYM2001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-05-12
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-005299-26
    A.3Full title of the trial
    An Open Label, Phase 2 Study to Evaluate Efficacy and Safety of Daratumumab in Relapsed or
    Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Efficacy and Safety Proof of Concept Study of Daratumumab in Relapsed/Refractory Mantle
    Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma
    A.4.1Sponsor's protocol code number54767414LYM2001
    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 SponsorJanssen-Cilag International N.V.
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International N.V.
    B.5.2Functional name of contact pointClinical Registry group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31 715242166
    B.5.5Fax number+31 715242110
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 No
    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/3/13/1153
    D.3 Description of the IMP
    D.3.1Product nameDaratumumab
    D.3.2Product code HuMax-CD38
    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 INNDaratumumab
    D.3.9.1CAS number 945721-28-8
    D.3.9.2Current sponsor codeJNJ-54767414 (Daratumumab)
    D.3.9.3Other descriptive nameHUMAX-CD38
    D.3.9.4EV Substance CodeSUB29447
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Yes
    D.3.11.13.1Other medicinal product typehuman monoclonal antibody
    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 or Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma
    E.1.1.1Medical condition in easily understood language
    Relapsed or Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level HLT
    E.1.2Classification code 10012819
    E.1.2Term Diffuse large B-cell lymphomas
    E.1.2System Organ Class 100000004851
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level HLT
    E.1.2Classification code 10016903
    E.1.2Term Follicle centre lymphomas, follicular grade I, II, III
    E.1.2System Organ Class 100000004851
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level HLT
    E.1.2Classification code 10026798
    E.1.2Term Mantle cell lymphomas
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The study will evaluate daratumumab separately in three relapsed or refractory NHL subtypes
    that are CD38 positive: MCL, DLBCL, and FL. There are two main objectives:
    -To assess overall response rate (ORR, including complete response (CR) and partial
    response (PR)), of daratumumab in subjects with CD38+ disease in each NHL subtype.
    -To evaluate association between ORR and CD38 expression level in order to determine a
    threshold for CD38 expression level in each NHL subtype, above which daratumumab
    activity is enhanced.
    E.2.2Secondary objectives of the trial
    For each subtype of NHL, the secondary objectives are:
    -To assess the duration of response (DoR), PFS and OS
    -To assess time to response
    -To assess and correlate the CD38 expression level with DoR, PFS and OS
    -To assess pharmacokinetics of daratumumab
    -To assess immunogenicity of daratumumab
    -To assess the safety profile of daratumumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Has diagnosis and prior treatment for each non-hodgkin's lymphoma (NHL) subtype as
    defined below: Mantle cell lymphoma (MCL): pathologically verified diagnosis of MCL based on local
    pathology report, relapsed or refractory disease after at least 2 but not more than 5 prior lines of therapy,
    including at least one cycle of ibrutinib therapy and documented progressive disease (PD) during or after
    ibrutinib treatment or participants who could not tolerate ibrutinib (ie, discontinued ibrutinib due to adverse
    events [AEs]), b) Diffuse large B cell lymphoma (DLBCL): pathologically confirmed diagnosis of nontransformed
    DLBCL, and c) relapsed or refractory disease; participants are not eligible or considered a
    candidate for high-dose chemotherapy and autologous stem cell transplantation due to other organ
    dysfunction or comorbidities (especially pulmonary or cardiac), c) Follicular lymphoma (FL): pathologically
    confirmed diagnosis of FL of Grade 1, 2, or 3a according to World Health Organization (WHO) criteria
    without pathological evidence of transformation, and relapsed disease after at least two prior systemic
    therapies including one anti-CD20 containing combination regimen - At least 1 measurable site of disease -
    Expression of CD38 by immunohistochemistry on fresh or archived tumor sample by central assessment:
    a) Stage 1: participants whose tumors are more than or equal to (>=) 50 percent (%) positive for CD38, b)
    Stage 2: participants whose tumors are >=1% positive for CD38 - Participant must have an ECOG
    performance status score of 0 or 1 - Women of childbearing potential must commit to either abstain
    continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control
    simultaneously. A woman of childbearing potential must have a negative serum or urine pregnancy test
    within 14 days prior to Cycle 1 Day 1. A man who is sexually active with a woman of childbearing potential
    must agree to always use condom during sexual intercourse, and all men must also not donate sperm
    during the study and for 4 months after receiving the last dose of study drug
    E.4Principal exclusion criteria
    •Known central nervous system lymphoma
    •Prior anti-tumor therapy including (all times measured prior to start of study drug):
    -nitrosoureas within 6 weeks
    -chemotherapy within 3 weeks
    -therapeutic antibodies within 4 weeks
    -radio- or toxin-immunoconjugates within 10 weeks
    -radiation therapy within 2 weeks
    -investigational agents within 3 weeks, unless antibody this should be within 4 weeks
    -Daratumumab or other anti-CD38
    •Participant has a history of malignancy (other than NHL) within 5 years before the screening
    period (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix,
    non-muscle invasive bladder cancer (papillary neoplasms of low malignant potential and primary noninvasive
    tumors), or malignancy that in the opinion of the investigator, with concurrence with the sponsor's
    medical monitor, is considered cured with minimal risk of recurrence within 3 years) - Participant has known
    chronic obstructive pulmonary disease (COPD) with a Forced Expiratory Volume in 1 second (FEV1) less
    than (<) 50% predicted normal. Note that FEV1 testing is required for patients suspected of having COPD
    and participants must be excluded if FEV1 <50% b) Participant has known moderate or severe persistent
    asthma within 2 years (see Attachment 4: NHLBI table of asthma severity), or currently has uncontrolled
    asthma of any classification. (Note that participants who currently have controlled intermittent asthma or
    controlled mild persistent asthma are allowed in the study)
    therapies
    E.5 End points
    E.5.1Primary end point(s)
    Number of Participants With Overall response rate (ORR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Approximately 3.5 years
    E.5.2Secondary end point(s)
    1. Duration of response (DoR)
    2. Progression Free Survival (PFS)
    3. Overall survival (OS)
    4. Time to response
    E.5.2.1Timepoint(s) of evaluation of this end point
    Approximately 3.5 years
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belgium
    France
    Korea, Republic of
    Netherlands
    Turkey
    United States
    E.8.7Trial has a data monitoring committee No
    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
    The end of the study for each NHL subtype is defined as 18 months after the last subject in the particular NHL subtype receives the first dose of daratumumab. After each NHL subtype completes the study, the sponsor will ensure that subjects who are currently on treatment and receiving benefit, as determined by the investigator, will continue to receive daratumumab. The end of the study is defined as the completion of all three NHL subtypes
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months1
    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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 210
    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)
    This is described in protocol under sections for EOT and follow up.
    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 Decision2015-05-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-09
    P. End of Trial
    P.End of Trial StatusCompleted
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