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    Summary
    EudraCT Number:2006-004093-27
    Sponsor's Protocol Code Number:ML20493
    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:2007-02-15
    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 number2006-004093-27
    A.3Full title of the trial
    A multicenter, phase II, open-label study evaluating the benefit of addition of MabThera (rituximab) to standard chemotherapies in patients with previously untreated mantle cell lymphoma.
    A.3.2Name or abbreviated title of the trial where available
    REMENY
    A.4.1Sponsor's protocol code numberML20493
    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 (Hungary) Ltd.
    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 Yes
    D.2.1.1.1Trade name MabThera 100mg and 500mg
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 RO 0452294
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNrituximab
    D.3.9.2Current sponsor codeRO0452294
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNrituximab
    D.3.9.2Current sponsor codeRO 0452294
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 No
    D.3.11.8Extractive medicinal product No
    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 typeimmunological medicinal product (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
    Mantle cell lymphoma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10061275
    E.1.2Term Mantle cell lymphoma
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective
    • To evaluate the benefit of adding MabThera® (rituximab) to chemotherapy of MCL patients by measuring induction of response (CR(u), PR)
    E.2.2Secondary objectives of the trial
    Secondary objectives

    • To assess event driven survival endpoints (EFS, PFS)
    • To evaluate time to treatment failure (TTF)
    • To describe the safety and tolerability profile of MabThera® (rituximab) containing first line regimen in patients with MCL
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written and signed informed consent according to ICH/EU GCP and national/local regulations
    2. Male or female patients
    3. Age >18 years.
    4. Histologically proven mantle cell lymphoma: MCL must be proven by a histological examination of representative material (e.g. lymph node or bone marrow) within 4 weeks before induction of treatment. Cyclin D1 posititivity or t(11;14)(q13;q32) is desirable but not essential for diagnosis.
    5. Material (lymph node or bone marrow biopsy) must be available for possible farther review
    6. Previously untreated disease at stage II, III and IV, requiring therapy
    7. Life expectancy of at least 6 months
    8. Pre-study performance status ECOG 0, 1 or 2 (see Appendix)
    9. Women of childbearing potential must agree to follow accepted birth control methods during the trial
    10. Men must agree to follow accepted birth control methods during the trial in order not to father a child
    E.4Principal exclusion criteria
    1. Known hypersensitivity reaction to rituximab, known anti-murine antibody (HAMA) reactivity or known hypersensitivity to murine antibodies, or standard chemotherapy compounds or incorporated substances
    2. Previous treatment with rituximab
    3. Platelet count < 100 x 103 /mm3, WBC < 3.0 x 103 /mm3, unless clearly related to MCL bone marrow infiltration
    4. Patients with stage I disease
    5. Patients with central nervous system involvement
    6. Patients with a history of autoimmune hemolytic anemia or autoimmune thrombocytopenia
    7. Active malignancy other than MCL within 5 years before Day 1 of Cycle 1, with the exception of complete resection of basal cell carcinoma, sqamous cell carcinoma of the skin, or in situ malignancy
    E.5 End points
    E.5.1Primary end point(s)
    1. CR requires the following:
    • Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL.
    • All lymph nodes and nodal masses must have regressed to normal size (<1.5 cm in their greatest transverse diameter for nodes >1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in their greatest transverse diameter before treatment must have decreased to 1 cm in their greatest transverse diameter after treatment, or by more than 75% in the sum of the products of the greatest diameters (SPD).
    • The spleen, if considered to be enlarged before therapy based on a CT scan, must have regressed in size and must not be palpable on physical examination. However, no normal size can be specified because of the difficulties in accurately evaluating splenic and hepatic size. Any macroscopic nodules in any organs detectable on imaging techniques- attributed to be lymphoma-should no longer be present. Similarly, other organs considered to be enlarged before therapy due to involvement by lymphoma, such as liver and kidneys, must have decreased in size.
    • If the bone marrow was involved by lymphoma before treatment, the infiltrate must be cleared on repeated bone marrow biopsy of the same site. The sample in which this determination is made must be adequate (>20 mm biopsy core). Flow cytomtetric, molecular, or cytogenetic studies are not considered part of routine assessment to document persistent disease at the present time.

    2. CR/unconfirmed (CRu) includes those patients who fulfill criteria 1 and 3 above, but with one or more of the following features:

    • A residual lymph node mass greater than 1.5 cm greatest transverse diameter that has regressed by more than 75% in the SPD. Individual nodes that were previously confluent must have regressed by more than 75% in their SPD compared with the size of the original mass.
    • Indeterminate bone marrow (increased number or size of aggregates without cytological or architectural atypia).
    • If possible, for the confirmation of CR, PET-CT should be performed

    3. PR requires the following:

    • 50% decrease in SPD of the six largest dominant nodes or nodal masses. These nodes or masses should be selected according to the following features:
    • They should be clearly measurable in at least two perpendicular dimensions
    • They should be from as completed disparate regions of the body as possible, and
    • They should include mediastinal and retroperitoneal areas of disease whenever these sites are involved.
    • No increase in the size of the other nodes, liver or spleen.
    • Splenic and hepatic nodules must regress by at least 50% in the SPD.
    • With the exception of splenic and hepatic nodules, involvement of other organ is considered assessable and not measurable disease.
    • Bone marrow assessment is irrelevant for determination of a PR because it is assessable and not measurable disease, however, if positive, the cell type should be specified in the report and preferably confirmed by immunohistochemistry.
    • No new sites of disease.
    • Stable disease/No change (NC) is defined as less thank a PR (see above) but is not progressive disease (see below
    • Relapsed disease (RE) (after CR, Cru) requires the following:
    • Appearance of any new lesion or increase by ≥ 50% in the size of previously involved sites.
    • ≥ 50% increase in greatest diameter of any previously identified node greater than 1 cm in its short axis or in the SPD of more than one node.
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    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.8.4.1Number of sites anticipated in Member State concerned9
    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 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
    Patients with documented disease progression any time during the treatment must be discontinued from study treatment.
    Patients interrupting treatment for tolerance or toxicity reasons will not be considered as patients with events unless their disease progresses or a new anti-lymphoma treatment is introduced.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months6
    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 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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    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 Decision2007-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-05-25
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