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    The EU Clinical Trials Register currently displays   36784   clinical trials with a EudraCT protocol, of which   6075   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2009-011433-27
    Sponsor's Protocol Code Number:ML22489
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-12-06
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2009-011433-27
    A.3Full title of the trial
    A phase II multicenter open-label study of MabThera (Rituximab) addition to regularly prescribed chemotherapy in patients with untreated Mantle Cell Lymphoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II multicenter open-label study of MabThera (Rituximab) addition to regularly prescribed chemotherapy in patients with untreated Mantle Cell Lymphoma
    A.4.1Sponsor's protocol code numberML22489
    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 SponsorRoche Romania SRL
    B.1.3.4CountryRomania
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0041 (0)61 688 1111
    B.5.5Fax number0041 (0)61 691 9391
    B.5.6E-mailwelwyn.eudract@roche.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 Yes
    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 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.3.4Pharmaceutical 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 INNRituximab
    D.3.9.1CAS number 174722-31
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Mantle Cell Lymphoma
    Mantle Cell Lymphoma
    E.1.1.1Medical condition in easily understood language
    Mantle Cell Lymphoma
    Mantle Cell Lymphoma
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10061275
    E.1.2Term Mantle cell lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine Overall Response Rate(ORR) (expressed as CR and PR) in MCL patients treated with MabThera plus chemotherapy
    E.2.2Secondary objectives of the trial
    To determine Overall Survival(OS), Progression Free Survival (PFS) and toxicity of the treatment and to identify predictive factors for a positive prognosis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically confirmed mantle cell lymphoma (MCL) according to WHO classification prior to study inclusion. The diagnosis has to be confirmed by immunophenotyping CD 20+ (CD5+, CD23-, sIgM, cyclin D1, Ki 67 )
    2. At least 1 measurable or assessable site of disease; in case of bone marrow infiltration only, bone marrow aspiration/ biospy is mandatory for all staging evaluations
    3. Patients with untreated MCL (excepting radiotherapy used for palliative, not for curative purposes) at any stage requiring therapy in the opinion of the treating physician that are not eligible for Autologous Stem Cell Transplant.
    4. Age >18 years old
    5. ECOG PS 0-2
    6. Life expectancy >6 months
    7. Known MIPI at the time of diagnosis
    8. Women of child bearing potential must have negative pregnancy test and agree to use effective contraception during entire study therapy and 12 months thereafter; men must agree not to father a child during entire study therapy and 12 months thereafter
    9. Adequate hematological function within 28 days prior to the first rituximab infusion:
    • Haemoglobin≥ 8 g/dL
    • Absolute neutrophile count ≥1.5x109/L
    • Platelet count≥100x109/L
    10. Adequate hepatic and renal function:
    • Transaminases (ASAT and ALAT) ≤3 x upper limit of normal (ULN)
    • Total bilirubin ≤2 x ULN
    • Alkaline phosphatase ≤2 x ULN
    • Creatinine ≤2 mg/dL or calculated creatinine clearance ≥50 mL/min
    11. LVEF≥50 %
    12. Patients willing and able to comply to study protocol for the entire study duration
    13. Patient’s written informed consent

    E.4Principal exclusion criteria
    1. Known hypersensitivity to murine proteins or chemotherapy regimen
    2. Previous first line therapy
    3. History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or in situ cervical carcinoma within the last 5 years
    4. Active opportunistic infections requiring treatment
    5. Active HIV infection, hepatitis B or C
    6. Serious underlying conditions which could impair the patient ability to take part in the study (uncontrolled diabetes mellitus, severe cardiac dysfunction or angina, gastric ulcer, pulmonary, endocrinological or neurological disorder, psychiatric illness, active autoimmune disease)
    7. Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary disease or cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months
    8. Pregnancy and lactation
    9. Creatinine clearance ≤30 mL/min
    10. Major surgery other than diagnostic surgery within 28 days prior to study entry
    11. Patients regularly taking corticosteroids during the last 4 weeks
    12. Treatment within a clinical trial within 30 days before study entry
    13. Patients unable to comply to study protocol
    E.5 End points
    E.5.1Primary end point(s)
    To determine Overall Response Rate(ORR) (expressed as CR and PR) in MCL patients treated with MabThera
    plus chemotherapy
    no
    E.5.1.1Timepoint(s) of evaluation of this end point
    no
    no
    E.5.2Secondary end point(s)
    To determine Overall Survival(OS), Progression Free Survival (PFS) and toxicity of the treatment and to identify
    predictive factors for a positive prognosis.
    no
    E.5.2.1Timepoint(s) of evaluation of this end point
    no
    no
    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 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 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.8.4.1Number 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
    Last Visit of the Last Subject
    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 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.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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
    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 Decision2009-11-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-31
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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