Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2005-004630-41
    Sponsor's Protocol Code Number:H6Q-MC-JCBJ
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-02-10
    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 ConcernedSweden - MPA
    A.2EudraCT number2005-004630-41
    A.3Full title of the trial
    A Phase 3 Clinical Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PRELUDE: Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin
    A.3.2Name or abbreviated title of the trial where available
    PRELUDE
    A.4.1Sponsor's protocol code numberH6Q-MC-JCBJ
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00332202
    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 SponsorEli Lilly and Company
    B.1.3.4CountryUnited States
    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 supportNot applicable
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressChemin des Coquelicots, 16
    B.5.3.2Town/ cityVernier/Geneva
    B.5.3.3Post code1214
    B.5.3.4CountrySwitzerland
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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/3/07/442
    D.3 Description of the IMP
    D.3.1Product nameEnzastaurin
    D.3.2Product code LY317615
    D.3.4Pharmaceutical form 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 INNEnzastaurin Hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125 to then 500
    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 placeboTablet
    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
    high-risk diffuse large B-cell lymphoma (DLBCL )
    E.1.1.1Medical condition in easily understood language
    Lymph node cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare maintenance therapy with enzastaurin versus placebo, in terms of the overall disease-free survival (DFS) time in patients with DLBCL in first remission with high risk of relapse (initial IPI score ≥3) following R-CHOP using a 14- or 21-day cycle
    E.2.2Secondary objectives of the trial
    To compare time-to-event efficacy variables including rate of disease free survival at 2 years,event free survival between treatment arms,rate of event free survival at 2 years,overall survival time. To compare adverse events between treatment arms. To compare health-related quality of life using the FACT-Lym. To assess health status using the EQ-5D scale.
    To perform exploratory assessments of biomarkers relevant to enzastaurin and disease state and their correlation to clinical outcome. To characterize the pharmacokinetics (PK) of enzastaurin and its metabolites using a sparse sampling strategy.
    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) PK addendum, version 1.0 dated 17 Jan 2007: collection of additional PK samples in order to provide additional data for an exposure-response analysis
    2) ECG addendum, version 2.2 dated 27 Oct 2009: collection of extra ECGs to determine if long-term use of enzastaurin (>12 months) is associated with any general cardiac issues (as measured by changes in ECGs).
    E.3Principal inclusion criteria
    Patients may be included in the study only if they meet all of the following criteria:
    [1] have had a histologically confirmed diagnosis of DLBCL by the World Health Organization classification (Harris et al. 1999) at the time of original diagnosis. Pathology must be reviewed and confirmed prior to enrollment at the investigational site where the patient is entered. Patients may be entered and randomized based on local pathology; however, an independent centralized pathology review will be performed on all enrolled patients (see Section 6.4.1). Commonly accepted histological variants of DLBCL, such as immunoblastic lymphoma, primary mediastinal B-cell lymphoma, and T-cell rich B-cell lymphoma are allowed.
    [2] if any gallium scan was performed, the most recent gallium scan must be negative. However, gallium scans are not a required study procedure.
    [3] if any PET scan was performed, the most recent PET scan must be negative, as judged by local radiologist and/or physician (an
    independent centralized radiology review will also be performed on
    these patients). Exceptions may be made (after consultation with the Lilly clinical research physician) for patients with PET-positive lesions in which a subsequent confirmation procedure (for instance, biopsy) reveals the lesion is not due to DLBCL. However, PET scans are not a required study procedure. (See Protocol Section 6.1.1 for more information.)
    [4] have completed six or eight 21-day cycles of R-CHOP, or six to eight 14-day cycles of R-CHOP as first-line therapy for DLBCL. (Refer to Section 5.5 for recommended regimens.) Patient must have achieved a CR or CRu (and have not subsequently progressed) according to International Workshop criteria (Cheson et al. 1999), or must be PET scan negative (according to Juweid et al. 2007), as judged by local radiologist and/or physician (an independent centralized radiology review will also be performed on these patients). Exceptions may be made (after consultation with the Lilly clinical research physician) for patients with PET-positive lesions in which a subsequent confirmation procedure (for instance, biopsy) reveals the lesion is not due to DLBCL.
    [5] have an IPI score ≥3 at time of original diagnosis (refer to Protocol Attachment JCBJ.4).
    [6] have had Stage 3 or 4 disease, or have had Stage 2 with bulky disease (defined as >10 cm), at time of original diagnosis.
    [7] have given informed consent.
    [8] have an estimated life expectancy of at least 12 weeks.
    [9] have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) scale (see Protocol Attachment JCBJ.7; Oken et al. 1982).
    [10] exhibit patient compliance and geographic proximity that allow for adequate follow-up.
    [11] have adequate organ function as follows:
    - Hepatic: total bilirubin ≤1.5 times upper limit of normal (ULN);
    alanine transaminase (ALT) and aspartate transaminase (AST)
    ≤2.5 times ULN
    - Renal: serum creatinine <1.5 times ULN
    - Adequate bone marrow reserve: platelets ≥50 x 109/L, absolute
    neutrophil count (ANC) ≥1.0 x 109/L, hemoglobin ≥8 g/dL.
    [12] male and female patients with reproductive potential must use an approved contraceptive method, if appropriate (for example, intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after discontinuation of study treatment. Women with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
    [13] are at least 18 years of age.
    [14] Patient must receive on-study therapy no later than 90 days either from their last cycle (Day 1) of induction therapy or from the last day of consolidation radiotherapy.
    E.4Principal exclusion criteria
    Patients will be excluded from the study if they meet any of the following criteria:
    [15] have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
    [16] receive concurrent administration of any other systemic anticancer therapy. Also, any systemic anti-cancer agent (for example, methotrexate or etoposide, and including investigational agents) initiated for treatment of DLBCL in combination with R-CHOP is not allowed. Patients who had been receiving chronic therapy such as hormonal therapy (for example, tamoxifen), low-dose (7.5 mg/week) methotrexate, or corticosteroids prior to the diagnosis and treatment of DLBCL, may continue to receive these therapies while on study, after agreement with the Lilly clinical research physician; however, initiation of these medications while the patient is on study is not allowed. Intrathecal prophylaxis is allowed.
    [17] have received radiation therapy to more than one targeted lesion (local residual disease) for treatment of lymphoma or have not recovered from the acute effects of radiation therapy prior to study entry.
    [18] are pregnant or breastfeeding.
    [19] have central nervous system (CNS) metastases (unless the patient has completed successful local therapy for CNS metastases and has been off of corticosteroids for at least 4 weeks before starting study therapy). In the absence of a clinical suspicion of brain metastases, no screening computed tomography (CT) or magnetic resonance imaging (MRI) scan before enrollment is required.
    [20] have serious concomitant disorder, including active bacterial, fungal, or viral infection, incompatible with the study (at the discretion of the investigator).
    [21] are known to be HIV positive.
    [22] have a second primary malignancy (except adequately treated basal cell carcinoma of the skin or other cancer that is considered cured by surgical resection or radiation). Patients who had another malignancy in the past, but have been disease-free for more than 5 years, are eligible.
    [23] have a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV (see Attachment JCBJ.5). It is recommended that patients with a prolonged QT interval corrected for heart rate (QTc) > 450/470 msec (males/females) at baseline on electrocardiogram (ECG), and patients who have a congenital long QT syndrome in their own or family medical history should be excluded, at the investigator’s discretion. It is recommended that QTc be calculated using Fridericia correction formula (QTcF; see Attachment JCBJ.10). A patient may still be entered on study with prolonged QT-interval only after discussion and agreement between the principal investigator and the Lilly clinical research physician.
    [24] are unable to swallow tablets.
    [25] requires use of carbamazepine, phenobarbital, or phenytoin (refer to Section 5.7).
    [26] prior stem cell or bone marrow transplantation.
    [27] a prior clinical history of an indolent lymphoma.
    E.5 End points
    E.5.1Primary end point(s)
    Overall Disease Free survival is the primary efficacy endpoint. Overall DFS time is defined as the time from the date of study enrollment to the first date of objectively determined disease recurrence or death from any cause. For patients not known to have died as of the data cut-off date and who do not have objectively determined disease recurrence, overall DFS will be censored at the date of the last objectively determined disease-free assessment. For patients who receive subsequent anticancer therapy (after discontinuation from the study therapy) prior to objectively determined disease recurrence, overall DFS will be censored at the date of the latest objectively-determined disease-free assessment prior to the initiation of subsequent therapy.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Last Patient Entered Treatment + 3 years (LPET+3 years)
    E.5.2Secondary end point(s)
    Patients will continue to be followed for DFS for up to 5 years after LPET (LPET+5 years).
    E.5.2.1Timepoint(s) of evaluation of this end point
    LPET+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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Patient reported outcomes- Quality of Life
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA67
    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
    Argentina
    Australia
    Belgium
    Brazil
    Canada
    China
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Greece
    Hungary
    India
    Italy
    Japan
    Korea, Republic of
    Mexico
    Poland
    Portugal
    Spain
    Sweden
    Taiwan
    United Kingdom
    United States
    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
    The end of study will occur when a total of 366 deaths have been
    observed.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years9
    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 years9
    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: 350
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    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 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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 218
    F.4.2.2In the whole clinical trial 709
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2006-03-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-04-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-05-16
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 20 15:54:51 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA