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    Summary
    EudraCT Number:2005-000359-13
    Sponsor's Protocol Code Number:ML18167
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-03-04
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2005-000359-13
    A.3Full title of the trial
    Hungarian Study of Maintenance after Rituximab Pretreatment. A multicentre, phase III, open-label study evaluating the benefit of a long-term MabThera® (rituximab) maintenance therapy in patients with advanced follicular lymphoma after induction of response (CR(u) or PR) with a MabThera® (rituximab)-containing first line regimen
    A.3.2Name or abbreviated title of the trial where available
    HUSOM
    A.4.1Sponsor's protocol code numberML18167
    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 SponsorRoche (Magyarország) Kft
    B.1.3.4CountryHungary
    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 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
    D.2.1.2Country which granted the Marketing AuthorisationHungary
    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 nameMabThera
    D.3.2Product code RO0452294
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNrituximab
    D.3.9.1CAS number 174722-31
    D.3.9.2Current sponsor codeRO0452294
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500 to 50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNrituximab
    D.3.9.1CAS number 174722-31
    D.3.9.2Current sponsor codeRO0452294
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100 to 10
    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 Yes
    D.3.11.13.1Other medicinal product typerecombinant humanised 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
    Patients with advanced follicular lymphoma after induction of response (CR(u) or PR) with a MabThera® (rituximab)-containing first line regimen
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.1
    E.1.2Level PT
    E.1.2Classification code 10061170
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the benefit by determining event driven survival endpoints (EFS, PFS) of a long-term MabThera® (rituximab) maintenance therapy in patients with advanced follicular lymphoma after induction of response (CR(u) or PR) with a MabThera® (rituximab)-containing first line regimen.
    E.2.2Secondary objectives of the trial
    Secondary objective:
    To describe the safety and tolerability profile of a long-term MabThera® (rituximab) maintenance therapy in patients with advanced follicular lymphoma after induction of response (CR(u) or PR) with a MabThera® (rituximab)-containing first line regimen.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    a. Signed an IRB- approved written informed consent.
    b. Histologically confirmed follicular lymphoma grade 1, 2, or 3a (see Appendix C) with a lymph node biopsy performed within 4 months before the induction treatment and with material available for eventual further review
    c. Documented parameters for FLIPI determination (Appendix I) before induction therapy
    d. No previous antilymphoma treatment received before the induction chemotherapy. (Just first line treated patients are eligible.)
    e. Verified complete or partial remission (CR(u) or PR) (see Appendix A) after induction (Allowed induction treatments are listed in Appendix B). Staging (see Appendix C) must be started 4 weeks after the last MabThera® infusion in the induction scheme and must be completed 2 weeks before baseline. The maximum allowed period between the last infusion of the induction and first infusion of MabThera® maintenance therapy is 8 weeks. Eligible first line induction regimens before staging (Appendix B):
    i. MabThera® plus CVP chemotherapy (R-CVP), containing 8 cycles of CVP given together with 8 cycles of MabThera®
    ii. MabThera® plus CHOP chemotherapy (R-CHOP), containing 6-8 cycles of CHOP given together with 8 cycles of MabThera®.
    iii. 2 cycle of R-CVP followed by 6 cycle of R-CHOP. If the treatment of patient started by R-CVP, and the response after 2 cycle of R-CVP was unsatisfactory by the judgement of physician, the treatment can be continued by 6 cycles of R-CHOP
    f. Males or females, older than 18 years
    g. Expected survival > 4 months.
    h. Prestudy performance status ECOG 0, 1 or 2 (see Appendix D)
    i. Acceptable hematological status within two weeks prior to treatment start, including:
    I. Hb > 8.0 g/dL.
    II. WBC > 3.0 x 103/ mm3 (x 109/ L).
    III. Absolute granulocyte count (segmented neutrophils + bands x total WBC) >1.5 x 103/ mm3 (x 109/ L).
    IV. Platelet count >75 x 103/ mm3 (x 109/ L).
    j. Women must agree to follow accepted birth control methods during the trial. In case of men also an agreement for contraception is needed until the end of the first year after receiving the last infusion of maintenance treatment.
    E.4Principal exclusion criteria
    a. Grade 3b follicular lymphoma
    b. Any previous antilymphoma treatment before induction chemotherapy. (Relapsed patients)
    c. Patients received other induction pretreatment as specified in Appendix B
    d. Transformation to high grade lymphoma (except to grade 3a) of the previously existed follicular lymphoma
    e. Presence of CNS lymphoma.
    f. AIDS-related lymphoma.
    g. Active opportunistic or known HIV, HBV or HCV infection.
    h. Major surgery, other than diagnostic surgery, within 4 weeks prior to registration.
    i. Another primary malignancy (other than squamous cell carcinoma of the skin or in situ carcinoma of the cervix) for which the patient has not been disease-free for at least five years.
    j. Patients with abnormal liver function unless directly related to hepatic involvement by lymphoma.
    I. Total bilirubin >2.0 mg/d L (35 µmol/L).
    II. Alkaline phosphatase >3 x upper limit of normal range.
    III. AST (SGOT) >3 x upper limit of normal range.
    k. Patients with abnormal renal function (serum creatinine >2.0 mg/d L [177 µmol/L]).
    l. New York Heart Association Class III or IV heart disease (see Appendix E) or myocardial infarction within the past 6 months.
    m. Patients regularly taking corticosteroids during the last 4 weeks, unless administered at a dose equivalent to <20 mg/day prednisone for indications other than lymphoma or lymphoma-related symptoms.
    n. Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. active uncontrolled bacterial, viral, or fungal ongoing infection(s), hydronephrosis, uncontrolled diabetes mellitus, uncontrolled gastric ulcers, active autoimmune disease). Judgment is up to the investigator.
    o. Sensitivity or allergy to murine products
    p. Treatment within a clinical trial within 30 days prior to trial entry.
    q. Female patients who are pregnant or lactating.
    E.5 End points
    E.5.1Primary end point(s)
    Event-free survival (EFS). EFS being defined as time from baseline to progression, relapse, death from any cause, or institution of a new antilymphoma treatment (including chemo-, radio- or immunotherapies).
    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 No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    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 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 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 years8
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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 No
    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 state150
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 150
    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 Decision2005-06-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-06-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-08-12
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