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    Summary
    EudraCT Number:2009-016725-34
    Sponsor's Protocol Code Number:C18083/2048
    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:2010-04-07
    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 number2009-016725-34
    A.3Full title of the trial
    An Open-Label Study to Evaluate the Efficacy and Safety of Treatment With Bendamustine in Combination With Ofatumumab in Previously Untreated Patients With Indolent B-Cell Non-Hodgkin’s Lymphoma (NHL)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical research on the efficacy and safety of the experimantal drug Bendamustine and Ofatumumab in patients with a special kind of blood cancer called Indolent B-Cell Non-Hodgkin’s Lymphoma (NHL)
    A.3.2Name or abbreviated title of the trial where available
    BOREALIS
    A.4.1Sponsor's protocol code numberC18083/2048
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01108341
    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 SponsorCephalon, Inc.
    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 supportCephalon, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCephalon France
    B.5.2Functional name of contact pointNathalie Thomas-Pujol
    B.5.3 Address:
    B.5.3.1Street Address20 rue Charles Martigny
    B.5.3.2Town/ cityMaison-Alfort Cedex
    B.5.3.3Post code94704
    B.5.3.4CountryFrance
    B.5.4Telephone number+33149 81 11 54
    B.5.5Fax number+33149 81 11 11
    B.5.6E-mailnthomas-pujol@cephalon.fr
    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 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 nameBendamustine hydrochloride
    D.3.2Product code CEP-18083
    D.3.4Pharmaceutical form Powder 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 INNBendamustine hydrochloride
    D.3.9.1CAS number 3543-75-7
    D.3.9.2Current sponsor codeCEP-18083
    D.3.9.3Other descriptive nameCytostasan
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5.0
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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.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 nameOfatumumab
    D.3.2Product code GSK1841157
    D.3.4Pharmaceutical form 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 INNOfatumumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20.0
    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) Yes
    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
    Non-Hodgkin’s Lymphoma
    E.1.1.1Medical condition in easily understood language
    Blood Cancer
    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 13.1
    E.1.2Level PT
    E.1.2Classification code 10029547
    E.1.2Term Non-Hodgkin's 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
    The primary objective of the study is to determine the efficacy, as measured by overall response (complete response [CR] + partial response [PR]), of bendamustine in combination with ofatumumab in previously untreated patients with indolent B-Cell Non-Hodgkin’s Lymphoma (NHL).
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are as follows:
    • to determine the CR rate of bendamustine in combination with ofatumumab in previously untreated patients with indolent B-Cell NHL
    • to assess the safety and tolerability of bendamustine in combination with ofatumumab in previously untreated patients with indolent B-Cell NHL by assessing the following:
    occurrence of adverse events throughout the study
    ― serum chemistry test results at the beginning of each cycle
    ― hematology test results on days 1 and 15 of each cycle (and on days 8 and 22 of cycle 1)
    ― vital signs measurements at each visit
    ― physical examination findings at the beginning of each cycle
    ― body weight measurements at day 1 of each cycle
    ― Eastern Cooperative Oncology Group (ECOG) performance status at the beginning of each cycle
    ― concomitant medication usage throughout the study
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients are included in the study if all of the following criteria are met:
    (a) The patient has histopathologic confirmation of 1 of the following CD20+ B-cell non-Hodgkin’s lymphomas (WHO/Revised European American Classification of Lymphoid Neoplasms [REAL] classifications described below [see Appendix F]). Tissue diagnostic procedures must be performed within 6 months of study entry and with biopsy material available for review:
    ― follicular lymphoma (grade 1 to 3a) (see Appendix G)
    ― immunoplasmacytoma/immunocytoma/lymphoplasmacytic lymphoma
    (Waldenstrom’s macroglobulinemia)
    ― splenic marginal zone B-cell lymphoma
    ― extra-nodal marginal zone lymphoma of mucosa associated lymphoid tumor (MALT) type
    ― nodal marginal zone B-cell lymphoma
    (b) The patient meets 1 of the following need-for–treatment criteria:
    ― presence of at least 1 of the following B-symptoms:
    • fever (>38ºC) of unclear etiology
    • night sweats
    • weight loss of greater than 10% within the prior 6 months
    ― large tumor mass (bulky disease) characterized by lymphomas with a diameter of more than 3 cm in 3 or more regions or by a lymphoma with a diameter of more than 7 cm in 1 region
    ― presence of lymphoma-related complications, including narrowing of ureters or bile ducts, tumor-related compression of a vital organ, lymphoma induced pain, cytopenias related to lymphoma/leukemia, splenomegaly, pleural effusions, or ascites
    ― hyperviscosity syndrome due to monoclonal gammopathy
    (c) The patient’s tumor is verified to be CD20+ positive from current or previous excisional or incisional tissue diagnostic procedures performed within 6 months of study entry. The excisional or incisional tissue diagnostic procedure has to be redone if there is clinical suspicion that the indolent lymphoma has transformed to
    aggressive lymphoma or a higher malignancy grade.
    (d) The screening phase CT scan (based on local evaluation) shows:
    ― 2 or more clearly demarcated lesions with a largest diameter ≥1.5 cm, or
    ― 1 clearly demarcated lesion with a largest diameter ≥2.0 cm
    (e) Inclusion criterion (e) is replaced by (e1).
    (e1) The patient was not previously treated for indolent lymphoma (with the exception of a single course of local radiation therapy not exceeding 2 adjacent lymph node regions).
    (f) The patient has adequate hematologic function (unless abnormalities are related to lymphoma infiltration of the bone marrow or hypersplenism due to lymphoma) as evidenced by the following:
    ― hemoglobin of 9.0 g/dl or greater without a growth factor
    ― absolute neutrophil count (ANC) of 1.5 x 109/L or greater without a growth factor
    ― platelet count of 75 x 109/L or greater independent of a platelet transfusion
    (g) The patient has the ability to provide written and dated informed consent.
    (h) The patient is 18 years of age or older at the time of informed consent.
    (i) The patient has ECOG performance status 0, 1, or 2.
    (j) The patient has serum creatinine of 2.0 mg/dL or less or creatinine clearance of 30 mL/min or more based on the Cockcroft-Gault method (see Appendix H) or from a 24-hour urine collection.
    (k) The patient has adequate hepatic function as evidenced by total bilirubin 1.5 times the ULN or less, unless secondary to Gilbert’s disease, and ALT and AST 2.5 times the ULN or less.
    (l) Women of childbearing potential (not surgically sterile or at least 12 months naturally postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 6 months after the end of treatment. Acceptable methods of contraception include abstinence, barrier method with spermicide (excluding cervical cap and sponge),
    intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method.
    (m) Men not surgically sterile or who are capable of producing offspring must practice abstinence or use a barrier method of birth control, and must agree to continue use of this method for the duration of treatment and for 6 months after the end of treatment.
    E.4Principal exclusion criteria
    Patients are excluded from participating in this study if 1 or more of the following criteria are met:
    (a) Exclusion criterion (a) is replaced by (a1).
    (a1) The patient has small lymphocytic lymphoma or mantle cell lymphoma.
    (b) Exclusion criterion (b) is deleted.
    (c) The patient has documented history of central nervous system (CNS) lymphomatous involvement.
    (d) The patient has or has had an active malignancy, other than NHL, within the past 3 years except for localized prostate cancer without evidence of bone metastases,bladder, cervical, or breast carcinoma in-situ, or non-melanoma skin cancer
    (e) The patient has New York Heart Association (NYHC) Class III or IV heart failure, uncontrolled arrhythmias or unstable angina, electrocardiographic evidence of active ischemia or active conduction system abnormalities, or myocardial infarction within the last 6 months.
    (f) The patient has known human immunodeficiency virus (HIV) infection
    (g) Exclusion criterion (g) is replaced by (g1).
    (g1) The patient has acute or chronic hepatitis B or hepatitis C infection.
    (h) The patient is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)
    (i) The patient has any serious uncontrolled, medical or psychological disorder that would impair the ability of the subject to receive study drugs.
    (j) The patient has any condition which places the patient at unacceptable risk or confounds the ability of the investigators to interpret study data.
    (k) The patient has received other investigational agent within 30 days of study entry.
    (l) The patient has known hypersensitivity to mannitol.
    (m) The patient has Ann Arbor stage I disease.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy measure is the proportion of patients with the outcome of complete response or partial response (overall response) determined by the IWG criteria during treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Each 3th cycle
    E.5.2Secondary end point(s)
    not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 No
    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
    United States
    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
    LPLV at 3 months post treatment follow up visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months12
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 6
    F.4.2.2In the whole clinical trial 51
    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)
    3 Months after last treatment dosing patients has the post-treatment visit as end of the study for the patient. At this visit the investigator is expected to discuss further therapy with the patient.
    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 Decision2010-04-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-05-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-10-03
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