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    Summary
    EudraCT Number:2014-000132-41
    Sponsor's Protocol Code Number:B3281006
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-06-04
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2014-000132-41
    A.3Full title of the trial
    A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY OF PF-05280586 VERSUS RITUXIMAB FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH CD20-POSITIVE, LOW TUMOR BURDEN, FOLLICULAR LYMPHOMA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study comparing the efficacy, safety, pharmacokinetics and immunogenicity of PF-05280586 versus commercially available rituximab in treating patients with low tumor burden follicular lymphoma in the first-line treatment setting.


    A.4.1Sponsor's protocol code numberB3281006
    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 SponsorPfizer Inc., 235 East 42nd Street, New York, NY 10017
    B.1.3.4CountryUnited States
    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 supportPfizer Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinicalTrials.gov Call Centre
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018007181021
    B.5.5Fax number0013037391119
    B.5.6E-mailclinicaltrials.gov_inquiries@pfizer.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 AuthorisationEuropean Union
    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 174722-31-7
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    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.IMP: 2
    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 No
    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 nameRituximab-Pfizer
    D.3.2Product code PF-05280586
    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 INNnot applicable
    D.3.9.2Current sponsor codePF-05280586
    D.3.9.3Other descriptive nameRituximab-Pfizer
    D.3.9.4EV Substance CodeSUB64137
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    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 typeBiosimilar medicinal product
    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
    low tumor burden follicular lymphoma
    E.1.1.1Medical condition in easily understood language
    low tumor burden follicular lymphoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10025320
    E.1.2Term Lymphomas non-Hodgkin's B-cell
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of rituximab-Pfizer to rituximab-EU when administered as a first-line treatment to patients with CD20-positive, low tumor burden follicular lymphoma (LTB-FL).
    E.2.2Secondary objectives of the trial
    •To evaluate the safety of rituximab-Pfizer and rituximab-EU.
    •To evaluate the population pharmacokinetics of rituximab-Pfizer and rituximab-EU.
    •To evaluate the immunogenicity of rituximab-Pfizer and rituximab-EU.
    •To characterize CD19-positive B-cell depletion and recovery in patients receiving rituximab-Pfizer and rituximab-EU.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
    1. Male or female patients aged 18 years (or local age of maturity for providing informed consent if greater than 18 years) or older.
    2. Histologically confirmed, Grade 1-3a, CD20-positive follicular lymphoma (containing no elements of diffuse large B-cell lymphoma).
    NOTE: Patients can be entered based on a diagnosis of CD20+ follicular lymphoma confirmed at the investigational site. Archival tissue or slides must be sent to the central pathology reviewer for confirmation of diagnosis. Patients must have tissue specimens available for the central pathology review to be enrolled.
    3. Ann Arbor Stage II, III, or IV.
    4. Eastern Cooperative Oncology Group (ECOG) status of 0 to 1.
    5. At least 1 measureable disease lesion identifiable by imaging:
    • A nodal lesion must be at least 11 mm x 11 mm OR ≥16 mm in the greatest transverse diameter [regardless of short axis measurement].
    • An extranodal lesion must be at least 10 mm x 10 mm.
    6. Patient has low tumor burden FL defined as:
    a. Serum LDH ≤1.5 upper limit of normal.
    b. β2-microglobulin ≤1.5 upper limit of normal.
    c. Largest nodal or extra-nodal mass <7 cm in diameter.
    d. No more than 3 nodal sites with a diameter >3 cm.
    e. No clinically significant serious effusions detectible on chest radiography.
    f. Spleen enlargement ≤16 cm by CT (computed tomography) scan.
    g. No complications such as organ compression or impairment.
    h. No B symptoms:
    • fever >38◦C for 3 consecutive days;
    • recurrent, drenching night sweats;
    • Unintentional weight loss exceeding 10% body weight in 6 months.
    NOTE: Patients with mild FL symptoms may be enrolled in the study as long as they do not meet the criteria for B symptoms.
    7. Men and women of childbearing potential must agree to use a highly effective method of contraception throughout the study and for 12 months after the last dose of assigned treatment. A man or woman is of childbearing potential if, in the opinion of the investigator, he or she is biologically capable of having children and is sexually active.
    8. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
    9. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    E.4Principal exclusion criteria
    Patients presenting with any of the following will not be included in the study:
    1. Patients who are not candidates for rituximab monotherapy in the opinion of the investigator.
    2. Evidence of histologic transformation to high-grade or diffuse large B-cell lymphoma.
    3. Central nervous system or meningeal involvement or cord compression by the lymphoma (Brain imaging is not required, but may be conducted if clinically indicated).
    4. Any previous history of T-cell lymphoma.
    5. Subjects with ≥ 5000/mm3 circulating lymphoma cells
    6. Any prior systemic therapy for B-cell NHL, including chemotherapy, immunotherapy, or steroids. Patients may have received prior localized radiotherapy for FL (Low dose [10 mg oral prednisone or equivalent] or inhaled steroids for other conditions are acceptable).
    7. Any prior treatment with rituximab.
    8. Hypersensitivity to the active substances or to any of the excipients in rituximab-Pfizer or rituximab-EU.
    9. History of allergy or prior hypersensitivity to murine, chimeric,
    humanized, or human monoclonal antibody treatments.
    10.Impaired bone marrow function as evidenced by hemoglobin < 9.0 g/dL, absolute neutrophil count (ANC) < 1.5 x 10x9 cells/L (1500/mm3) or a platelet count <75 x 10x9cells/L (75,000/mm3).
    11. Symptomatic ischemic heart disease or NYHA Class II, III, or IV congestive heart failure.
    12. Active infection with tuberculosis (TB). Patients with evidence of latent TB or a history of TB must have completed treatment or have initiated treatment for at least 1 month before the first dose of study treatment (Day 1). TB testing is required only if it is required by local regulations or practice.
    13. Positive test for hepatitis B surface antigen (HBsAg), hepatitis B core
    antibody (HBcAb), or anti-hepatitis C antibody (HCVAb), or seropositivity
    for human immunodeficiency virus (HIV).
    14. Any other active uncontrolled infection. Patients with an infection
    must have initiated a course of treatment with an effective antimicrobial
    a minimum of 7 days before the first dose of study treatment (Day 1)
    and be free of symptoms from the infection.
    15. Any history of another cancer during the last 5 years with the
    exception of non-melanoma skin tumors, in situ cervical carcinoma, or in
    situ breast cancer treated with curative intent with no history of
    metastatic disease.
    16. Administration of a live vaccine ≤ 6 weeks before first dose of study treatment (Day 1).
    17. Major surgery ≤28 days before first dose of study treatment.
    18. Anticipated need for concomitant administration of any other experimental drug, or a concomitant chemotherapy, anticancer hormonal therapy, radiotherapy, or immunotherapy during study participation.
    19. Participation in other studies involving investigational drug(s) (Phases 1-4) within 4 weeks or 5 half-lives, whichever is longer, before the current study begins and/or during study participation.
    20. Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
    21. Patients who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the investigator, or patients who are Pfizer employees directly involved in the conduct of the trial.
    22. Pregnant females; breastfeeding females; males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for 12 months after last dose of investigational product.
    23. Patients with a body surface area > 3.0 m2
    E.5 End points
    E.5.1Primary end point(s)
    Overall Response Rate (ORR) at Week 26 of rituximab-Pfizer and rituximab-EU based on central radiology review in accordance with the revised response criteria for malignant lymphoma
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 26
    E.5.2Secondary end point(s)
    •Safety characterized by type, incidence, severity, timing, seriousness, and relationship to study therapy of adverse events and laboratory abnormalities.
    •Time to Treatment Failure (TTF).
    •Progression-Free Survival (PFS).
    •Complete Remission (CR) rate at Week 26.
    •Duration of response.
    •Overall survival.
    •Peak and trough drug concentrations.
    •CD19-positive B-cell counts.
    •Incidence of anti-drug antibodies (ADA), including neutralizing antibodies (NAb), and safety associated with immune response.
    E.5.2.1Timepoint(s) of evaluation of this end point
    please refer to the 'Schedule of Activities' table provided within the protocol pages 7-9.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    immunogenicity
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA90
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Belarus
    Belgium
    Brazil
    Croatia
    Egypt
    France
    Germany
    Greece
    India
    Italy
    Japan
    Korea, Republic of
    Lebanon
    Mexico
    Peru
    Philippines
    Poland
    Portugal
    Puerto Rico
    Romania
    Russian Federation
    Serbia
    Slovakia
    South Africa
    Spain
    Switzerland
    Taiwan
    Thailand
    Turkey
    Ukraine
    United Kingdom
    United States
    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
    as per Protocol Section 13.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 157
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 237
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 106
    F.4.2.2In the whole clinical trial 394
    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)
    As per protocol
    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 Decision2014-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-04-19
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