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    Summary
    EudraCT Number:2005-004977-12
    Sponsor's Protocol Code Number:MO19872
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-03-12
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2005-004977-12
    A.3Full title of the trial
    Estudio en fase IIIb sobre el tratamiento de mantenimiento con MabThera® (rituximab) en pacientes con linfoma no hodgkiniano folicular que han respondido al tratamiento de inducción.

    A Phase IIIb study of MabThera® (rituximab) maintenance therapy in patients with follicular Non-Hodgkin’s Lymphoma who have responded to induction therapy.
    A.3.2Name or abbreviated title of the trial where available
    MAXIMA
    A.4.1Sponsor's protocol code numberMO19872
    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 SponsorF. Hoffmann-La Roche Limited
    B.1.3.4CountrySwitzerland
    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
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Concentrate for solution for injection
    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.3.10 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) 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 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
    Linfoma no Hodkiniano folicular

    Follicular non Hodgkin's Lymphoma (NHL)
    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
    to evaluate the safety of rituximab maintenance therapy following a rituximab-containing induction regimen in first line or relapsed patients with follicular Non-Hodgkin’s Lymphoma
    E.2.2Secondary objectives of the trial
    to further confirm the effectiveness of rituximab maintenance therapy with respect to Progression Free Survival (PFS), Event Free Survival (EFS), Time to Next Lymphoma Treatment (TNLT), Overall survival (OS), and the Partial Response (PR) to complete response/complete response unconfirmed (CR/Cru) conversion rate while on rituximab maintenance therapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed written informed consent form.
    (For Germany see also Section 17.11.1)
    2. Histologically confirmed, CD20+, Grade 1, 2 or 3a follicular non-Hodgkin’s lymphoma.
    3. Patients must have received adequate induction therapy either as first line treatment or patients must have received adequate induction therapy as treatment for relapsed disease.
    • Adequate induction therapy is defined as treatment with a minimum of 8 cycles of rituximab either as monotherapy, or combined with chemotherapy. The time elapsed from the first to the last of the last 8 induction infusions should not exceed 30 weeks.
    • The type of chemotherapy and the number of cycles added to 8 cycles of rituximab is according to the investigator’s judgment (e.g., 6 x CVP + 8 x rituximab would be considered adequate for this study).
    4. Patients must have a computerised tomography CT (or Positron Emission Tomography [PET] or Magnetic Resonance Imaging [MRI]) documented response to induction therapy: PR, CR or CRu. Response assessment must be made within eight weeks of study entry. For lymphomas that cannot be measured by radiographic techniques (e.g. follicular lymphoma of the stomach) appropriate measurements replacing radiographic images need to be used (e.g. gastroscopy).
    5. Induction therapy should have been completed to allow the first rituximab maintenance administration to occur eight to twelve weeks after day 1 of the last induction cycle (1 week before, or 2 weeks after, the period of eight to twelve weeks may be tolerated if these changes are due to documented administrative problems at the study site beyond the control of the site staff).
    • If patients are recovering from chemotherapy related toxicity from the most recent rituximab-containing induction therapy, they may receive their first rituximab maintenance therapy infusion up to six months after day 1 of the last cycle of induction therapy.
    6. Patients must be ≥ 18 years old.
    7. Patients must have a performance status ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale.
    8. Adequate haematological function within 28 days prior to their first rituximab maintenance infusion. This includes:
    • Haemoglobin ≥ 8.0g/dL (5.0 mmol/L),
    • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L,
    • Platelet count ≥ 100 x 109/L. (Lower platelet counts [≥ 50 x 109/L] are acceptable if low level is due to toxicity of previous chemotherapy and not accompanied by bleeding.)
    9. Patients must have immunoglobulin of type G (IgG) levels ≥ 2g/L within 28 days prior to their first rituximab maintenance infusion.
    10. Agree to use effective contraception, and agree not to become pregnant during participation in the study or within 12 months after the last rituximab maintenance infusion. Men agree not to father a child during participation in the study or within 12 months after the last rituximab maintenance infusion. (For Germany see also Section 17.11.1)
    E.4Principal exclusion criteria
    11. Patients with poor compliance during induction therapy; judgment is up to investigators
    2. Patients who had significant delays / interruptions in their induction therapy such that completion of the planned rituximab therapy was more than four months longer than the planned schedule.
    3. Stable disease (SD) or progressive disease (PD) after most recent induction therapy.
    4. Transformation to high-grade lymphoma (secondary to “low-grade” follicular lymphoma).
    5. Presence or history of central nervous system (CNS) lymphomatous disease (e.g., CNS lymphoma or lymphomatous meningitis).
    6. Patients regularly taking corticosteroids during the last 4 weeks, unless administered at a dose equivalent to < 20 mg/day prednisone.
    7. Patients with prior or concomitant malignancies other than a follicular non-Hodgkin’s lymphoma, except for non melanoma skin cancer, adequately treated in situ cervical cancer, or patients who have had previous cancers if they are considered cured and there has been no evidence of recurrence in the last 3 years.
    8. Major surgery (excluding lymph node biopsy) within 28 days prior to their first rituximab maintenance infusion.
    9. Poor hepatic function: total bilirubin > 2.0 mg/dL (34 μmol/L), alanine-amino-transferase (ALT) > 3 x the upper limit of normal (ULN) unless these abnormalities are related to lymphoma.
    10. Patients who have known human immuno-deficiency virus (HIV) infection or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
    11. Serious underlying medical conditions, which could impair the ability of the patient to participate in the study (e.g., uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease, uncontrolled hypertension or pre-existing cardiac condition). Judgment is up to the investigator.
    12. Pregnant patients cannot enter the study.
    • A negative serum pregnancy test is required for women of childbearing potential within seven days prior to first rituximab maintenance therapy infusion.
    13. Breast-feeding patients are not permitted to enter the study.
    14. Life expectancy of less than 6 months.
    15. Known sensitivity or allergy to murine products.
    (For Germany see also Section 17.11.1)
    16. Treatment within a clinical study within 30 days prior to study entry.
    (For Germany see also Section 17.11.1)
    17. Patients unable to provide informed consent or patients under protection from a guardian.
    (For Germany see also Section 17.11.1)
    18. Active infection requiring treatment, or chronic recurrent infection, e.g., osteomyelitis.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is safety. The following safety variables will be monitored during this study: AEs, laboratory tests and vital signs
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) 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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA211
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 the whole Study is defined as the date of the last 12-month follow up visit following rituximab maintenance therapy, or sooner if all patients have died or withdrawn their consent.


    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
    E.8.9.2In all countries concerned by the trial years5
    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 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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 500
    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 Decision2006-10-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-10-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-03-24
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