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    Summary
    EudraCT Number:2011-000919-22
    Sponsor's Protocol Code Number:OMB114578
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-09-16
    Trial 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 ConcernedUK - MHRA
    A.2EudraCT number2011-000919-22
    A.3Full title of the trial
    RIAltO: A Randomised Investigation of Alternative Ofatumumab-containing regimens in less fit patients with CLL
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to compare the safety and effectiveness of ofatumumab when given in combination with two different chemotherapy drugs called chlorambucil and bendamustine.
    A.3.2Name or abbreviated title of the trial where available
    RIAltO
    A.4.1Sponsor's protocol code numberOMB114578
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN09988575
    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 SponsorUniversity of Liverpool
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovartis Pharmaceutical UK Limited
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportNapp Pharmaceuticals Limited
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportChugai Pharma UK Limited
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportGilead Sciences Europe Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCR:UK Liverpool Cancer Trials Unit
    B.5.2Functional name of contact pointCharlotte Rawcliffe
    B.5.3 Address:
    B.5.3.1Street AddressWaterhouse Building, 1-3 Brownlow Street
    B.5.3.2Town/ cityLiverpool
    B.5.3.3Post codeL69 3GL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01517948167
    B.5.5Fax number01517955284
    B.5.6E-mailc.rawcliffe@liv.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorRoyal Liverpool Hospital, Liverpool University Hospitals NHS Foundation Trus
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSee B.4. above
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCR:UK Liverpool Cancer Trials Unit
    B.5.2Functional name of contact pointCharlotte Rawcliffe
    B.5.3 Address:
    B.5.3.1Street AddressWaterhouse Building, 1-3 Brownlow Street
    B.5.3.2Town/ cityLiverpool
    B.5.3.3Post codeL69 3GL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01517948285
    B.5.5Fax number01517948931
    B.5.6E-mailc.rawcliffe@liv.ac.uk
    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 Arzerra
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Group Ltd
    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 nameArzerra
    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 INNOfatumumab
    D.3.9.1CAS number 679818-59-8
    D.3.9.2Current sponsor codeGSK1841157
    D.3.9.3Other descriptive nameHuMax-CD20
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.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 Yes
    D.2.1.1.1Trade name Levact
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma GmbH
    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 nameLevact
    D.3.4Pharmaceutical form Powder for 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 INNBendamustine hydrochloride
    D.3.9.1CAS number 3543-75-7
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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: 3
    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 Leukeran
    D.2.1.1.2Name of the Marketing Authorisation holderAspen Pharma Trading 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 nameLeukeran
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNChlorambucil
    D.3.9.1CAS number 305-03-3
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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: 4
    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 Arzerra
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm 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 nameArzerra
    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 INNOfatumumab
    D.3.9.1CAS number 679818-59-8
    D.3.9.2Current sponsor codeGSK1841157
    D.3.9.3Other descriptive nameHuMax-CD20
    D.3.9.4EV Substance CodeAS5
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Lymphocytic Leukaemia
    E.1.1.1Medical condition in easily understood language
    An overproduction of abnormal white blood cells (lymphocytes) in the lymphatic system and bone marrow causing swollen lymph nodes and a decrease in the number of white and red cells and platlets made.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10008993
    E.1.2Term Chronic lymphoid leukaemia
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess whether progression free survival (PFS) time (i.e. the length of time during and after medication or treatment during which the disease being treated does not get worse) using ofatumumab plus bendamustine is longer than that using ofatumumab plus chlorambucil.
    E.2.2Secondary objectives of the trial
    To compare between the two treatment groups:
    a. Response including MRD negativity
    b. Duration of response
    c. Overall survival
    d. Time to treatment failure
    e. Toxicity
    f. Treatment dose administered
    g. Quality of life
    h. Health economic analysis
    i. Co-morbidity assessment
    j. Frailty assessment
    k. Predictive value of biomarkers


    In addition, treatment outcome will be analysed across biological subgroups defined by co-morbidity/frailty scores and laboratory biomarkers.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. CLL/Small Lymphocytic Leukamia (SLL) requiring treatment by NCI/IWCLL 2008 criteria. At least one of the following criteria:
    a. Evidence of progressive marrow failure as manifested by the development of, or worsening of, anaemia and/or thrombocytopenia.
    b. Massive (i.e. 6 cm below the left costal margin) or progressive or symptomatic splenomegaly.
    c. Massive (i.e. 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy.
    d. Progressive lymphocytosis with an increase of more than 50% over a 2-month period or lymphocyte doubling time (LDT) of less than 6 months from a baseline value of at least 30x10^9/l and not due to causes other than CLL
    e. Constitutional symptoms defines as at 10% unintentional weight loss within the previous 6 months; significant fatigue preventing usual activities, or fever of at least 38oc for at least 2 weeks or night sweats for at least one month in the absence of infection
    2. No prior cytotoxic or targeted therapy for CLL (prior localised radiotherapy is allowed).
    3. Full-dose R-FC considered inappropriate for at least one of the following reasons
    a. Age 75 or greater
    b. WHO performance status 2 or 3
    c. Cardiac impairment (NYHA class II)
    d. Respiratory impairment (bronchiectasis or moderate COPD)
    e. Renal impairment (estimated Glomerular Filtration Rate (eGFR) 10-30 ml/min)
    f. Any other significant co-morbidity or factor that makes R-FC inappropriate
    4. Considered able to tolerate Chl at the dose used in the LRF CLL4 trial (10mg/m2 d1-7)
    5. Written informed consent
    E.4Principal exclusion criteria
    1. Neutrophil count less than 1.0 x 109/l or platelet count less than 50 x 109/l unless due to CLL
    2. Uncontrolled auto-immune haemolytic anaemia or thrombocytopenia
    3. Active infection
    4. Seropositivity for HIV, HCV or HBV (surface antigen and core antibody)
    5. Severe renal impairment (eGFR less than 10ml/min)
    6. Serum bilirubin more than 1.5 the upper limit of normal unless due to CLL or Gilbert’s syndrome.
    7. Serum ALT or AST more than 2.5 the upper limit of normal unless due to CLL
    8. Ongoing alcohol or drug addiction.
    9. History of prior allogeneic bone marrow or solid organ transplantation.
    10. Concurrent treatment with glucocorticoids equivalent to more than prednisolone 20mg od
    11. Prior treatment with monoclonal antibody therapy within the last 3 months
    12. Yellow fever vaccination within 4 weeks prior to treatment start
    13. Known hypersensitivity to ofatumumab, bendamustine, chlorambucil or any of their excipients
    14. CNS involvement with CLL
    15. History of Richter transformation
    16. Concomitant malignancies within the last 3 years except successfully treated non-melanoma skin cancer or carcinoma in situ
    17. Major surgery within 28 days prior to randomisation
    18. WHO performance status 4
    19. Severe cardiac disease including unstable angina, acute myocardial infarction within six months prior to study entry, congestive heart failure (NYHA III-IV) and arrhythmias (excluding extrasystoles or minor conduction abnormalities) unless controlled by therapy.
    20. Any serious underlying medical or psychological conditions, which could impair the ability of the patient to participate in the trial or compromise ability to give informed consent
    21. Treatment within a clinical trial within 30 days prior to trial entry.
    22. Adult patient under tutelage (not competent to sign informed consent).
    23. Pregnant or lactating women.
    24. Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy. Adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence.
    25. Male subjects unable or unwilling to use adequate contraception methods from study start to one year after the last dose of protocol therapy.


    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (progression or death from any cause).
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of trial.
    E.5.2Secondary end point(s)
    a. Response including Minimum Residual Disease (MRD) negativity
    b. Duration of response
    c. Overall survival
    d. Time to treatment failure
    e. Toxicity
    f. Treatment dose administered
    g. Quality of life
    h. Health economic analysis
    i. Co-morbidity assessment
    j. Frailty assessment
    k. Predictive value of biomarkers
    E.5.2.1Timepoint(s) of evaluation of this end point
    a. Response including Minimum Residual Disease (MRD) negativity - cycles 4,7 & 10; 2 & 6 months post treatment; end of trial
    b. Duration of response - cycles 4,7 & 10; 2 & 6 months post treatment; end of trial
    c. Overall survival - end of trial
    d. Time to treatment failure - cycles 4,7 & 10; 2 & 6 months post treatment; end of trial
    e. Toxicity - every visit until 6 months post treatment
    f. Treatment dose administered - end of treatment
    g. Quality of life - every 3 months until end of trial
    h. Health economic analysis - every 3 months until end of trial
    i. Co-morbidity assessment - baseline; cycles 4, 7 & 10; 2 months post treatment; disease progression
    j. Frailty assessment - baseline
    k. Predictive value of biomarkers - baseline; months 6, 12, 18, 24, 30, 36, 42; progression
    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 No
    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 Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned120
    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 No
    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 last visit of the last patient will define the end of the trial. This will be followed by the completion of a study report.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days30
    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.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 state504
    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)
    If O-B is shown to be superior to O-Chl, NICE approval will be sought for the use of O-B in this indication.

    NICE approval is likely to be sought for use of O-Chl as front line therapy for less fit patients following the completion of the NCRI CLL7 (OMB110911 / COMPLEMENT-1) Phase III trial.

    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Cheshire & Merseyside Comprehensive Local Research Network
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-09-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-14
    P. End of Trial
    P.End of Trial StatusOngoing
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    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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