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    The EU Clinical Trials Register currently displays   38179   clinical trials with a EudraCT protocol, of which   6271   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).
     
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    Summary
    EudraCT Number:2005-003018-14
    Sponsor's Protocol Code Number:CLL7
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-01-26
    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 ConcernedAustria - BASG
    A.2EudraCT number2005-003018-14
    A.3Full title of the trial
    Randomized phase III trial comparing early treatment with
    fludarabine, cyclophosphamide + rituximab versus deferred
    treatment in untreated Binet stage A patients
    with high risk of progression
    CLL 7 protocol of the GCLLSG and FCGCLL
    A.4.1Sponsor's protocol code numberCLL7
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAKH Vienna
    B.1.3.4CountryAustria
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Mabthera
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited, UK
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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.3.2Product code RO 45-2294
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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
    chronic lymphocytic leukaemia (CLL)
    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
    1) A comparison of the effect of immediate versus deferred
    treatment with FCR in Binet stage A patients at high risk for
    disease progression on event free survival (EFS).
    2) Investigation and definition of a new prognostic staging system
    for patients with Binet stage A.
    E.2.2Secondary objectives of the trial
    Progression free survival (PFS)
    Time to progression to Binet stages B and C
    Time to treatment
    Quality of life
    Overall survival
    Pharmacoeconomic analyses
    For patients included in the early treatment arm, the following criteria will be
    assessed:
    • Overall response rate: complete remission (CR) and partial response
    (PR).
    • For patients in complete remission the percentage achieving
    complete molecular remission using the clone specific CDR-III
    region as follow-up parameter
    • Duration of response defined as the time elapsed between the first
    time a response is observed and re-treatment initiation
    • Adverse events related to treatment (treatment safety)
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1) Established diagnosis of B-CLL by NCI criteria (Cheson et al., 1996). Diagnosis will
    be retrospectively confirmed by an expert review committee. Immunophenotyping
    should be stored in list mode and one stained blood smear available.
    2) Binet stage A.
    3) First diagnosis within 12 months before inclusion in study.
    4) Start of therapy possible within 28 days after completed risk stratification/
    randomization.
    5) No prior chemotherapy, radiation or antibody treatment.
    6) Age > 18 years.
    7) Life expectancy > 6 months.
    8) ECOG performance status 0 - 2.
    9) Written informed consent of patient and treating physician.
    10) All parameters for risk stratification present.
    11) Willingness to accept contraception if randomized to cohort I for the
    duration of therapy and 12 months thereafter.
    12) Negative serum pregnancy test one week prior to treatment for premenopausal
    women.
    13) Ability to understand the protocol.
    14) Possibility of follow up.
    E.4Principal exclusion criteria
    1) Age < 18 years.
    2) ECOG performance status > 2.
    3) Clinically apparent autoimmune cytopenia, in particular antiglobulin test positive
    hemolytic anemia (positive antiglobulin test without anemia is not an exclusion
    criterion)
    4) Active secondary malignancy or chemotherapy/radiotherapy for any neoplastic disease
    other than B-CLL prior to the study
    5) Medical condition requiring the prolonged (estimated to be more than one month) use
    of oral corticosteroids
    6) History of anaphylactic reaction following exposure to humanized monoclonal
    antibodies
    7) Patients with active bacterial, viral or fungal infection
    8) Known infection with HIV, Hepatitis B or C
    9) Treatment with any other investigational agent or participating in another trial within
    30 days prior to entering this study
    10) Pregnancy and/or nursing
    11) Concurrent severe diseases which exclude the administration of therapy
    o heart insufficiency NYHA grade III/IV, LVEF < 50% and or RF <30%,
    myocardial infarction within the past 6 months prior to study
    o severe chronic obstructive lung disease with hypoxemia
    o severe diabetes mellitus
    o hypertension difficult to control
    o impaired renal function with creatinine clearance < 70 ml/min according to the
    formula of Cockroft and Gault
    o Serum bilirubin > 2 x ULN
    o Cerebral dysfunction or any other coexisting medical or psychological condition
    that woud preclude participation in the required study procedures
    12) Transformation to aggressive B cell malignancy (i.e. diffuse large cell
    lymphoma,
    Richter’s syndrome or prolymphocytic leukemia
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint "event free survival" (EFS) is defined as the time between inclusion in the study until progression, treatment or death.
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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 Information not present in EudraCT
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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 days
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-01-26. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 600
    F.4.2.2In the whole clinical trial 600
    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 Decision2006-03-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-03-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-04-21
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