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    Summary
    EudraCT Number:2014-000880-42
    Sponsor's Protocol Code Number:HM14/10152
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-09-30
    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 number2014-000880-42
    A.3Full title of the trial
    GALACTIC: GA-101 (obinutuzumab) monocLonal Antibody as Consolidation Therapy In CLL
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II/III trial to assess the use of obinutuzmab against no treatment in patients who have recently had a good response to previous treatment for Chronic Lymphocytic Leukaemia (CLL)
    A.3.2Name or abbreviated title of the trial where available
    GALACTIC version 1.0
    A.4.1Sponsor's protocol code numberHM14/10152
    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 Leeds
    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 supportCancer Research UK/Clinical Trials Advisory and Awards Committee (CRUK/CTAAC)
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportRoche Products Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNITED KINGDOM
    B.5.2Functional name of contact pointJamie Oughton
    B.5.3 Address:
    B.5.3.1Street AddressUniversity of Leeds
    B.5.3.2Town/ cityLeeds
    B.5.3.3Post codeLS2 9JT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01133431494
    B.5.5Fax number01133434345
    B.5.6E-mailj.oughton@leeds.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 Gazyvaro
    D.2.1.1.2Name of the Marketing Authorisation holderRoche
    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 nameObinutuzumab
    D.3.2Product code GA-101
    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 INNObinutuzumab
    D.3.9.1CAS number 949142-50-1
    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 number25
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Lymphocytic Leukaemia (CLL).
    E.1.1.1Medical condition in easily understood language
    Chronic Lymphocytic Leukaemia (CLL).
    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 17.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 principal research question this trial aims to answer is does obinutuzumab given within 3-12 months following a good response to prior treatment for chronic lymphocytic leukaemia (CLL) improve the length of time that patients are progression free when compared to having no consolidation treatment.

    The phase II primary objective is to determine the rate of achieving MRD negativity and to assess the safety of obinutuzumab in a consolidation setting.

    The phase III primary objective is to compare consolidation therapy with obinutuzumab against no consolidation therapy with respect to progression-free survival in participants who responded to previous therapy with a complete or good partial remission with low levels of MRD.
    E.2.2Secondary objectives of the trial
    To assess and compare between trial arms:
    • Proportion of participants with undetectable minimal residual disease (MRD) (as defined by the International Workshop on Chronic Lymphocytic Leukaemia (IWCLL) criteria)
    • Overall survival
    • Treatment-free survival
    • Response and rate of response to therapy (as defined by IWCLL criteria)
    • Progression-free survival and overall survival for participants who are or become MRD negative
    • Duration of MRD negativity for participants who become MRD negative
    • Safety and toxicity
    • Health related quality of life
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • At least 18 years old
    • Previous confirmation of B-CLL with a characteristic immunophenotype (for example, CD5+, CD19+, CD23+ lymphoproliferative disorder) on peripheral blood flow cytometry
    • Maximum of three prior therapies received for CLL treatment and between 3 and 24 months post therapy at registration.
    • Response to most recent chemotherapy treatment for CLL with PR, CRi or CR
    • World Health Organisation (WHO) performance status (PS) of 0 or 1
    • Able to provide written informed consent
    • Peripheral B-Cell count <5x10^9 L
    • For randomisation, the first MRD positive peripheral blood sample (disease level found in peripheral blood is greater than 0.01%) must be between 3 and 12 months since completing most recent therapy for CLL
    • Absence of clinically or radiologically evident lymphadenopathy (largest lymph node 1.5 cm or less in minimum diameter)
    • Creatinine and bilirubin <2 times upper limit of normal unless secondary to direct infiltration of the liver by CLL or haemolysis
    E.4Principal exclusion criteria
    • Disease progression after response to latest therapy
    • Active infection
    • Past history of anaphylaxis following exposure to rat or mouse derived CDR-grafted humanised monoclonal antibodies
    • Previous treatment with obinutuzumab
    • CNS involvement with CLL
    • Mantle cell lymphoma
    • Moderate or severe cardiac disease that would preclude treatment with obinutuzumab
    • Other severe, concurrent diseases or mental disorders that could interfere with ability to participate
    • Known HIV positivity
    • Active secondary malignancy excluding basal cell carcinoma
    • Active haemolysis
    • Patients previously treated with allogeneic Stem Cell Transplant
    • Pregnancy, lactation or women of child-bearing potential unwilling to use medically approved contraception whilst receiving treatment and for 12 months after treatment has finished
    • Men whose partners are capable of having children but who are not willing to use appropriate medically approved contraception whilst receiving treatment and for 12 months after treatment has finished, unless they are surgically sterile
    • Persisting severe pancytopenia (neutrophils <0.5 x 10^9/L or platelets <50 x 10^9/L) or trans fusion dependent anaemia
    • Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded.
    • Positive serology for Hepatitis C (HC) defined as a positive test for HCAb, in which case reflexively perform a HC RIBA immunoblot assay on the same sample to confirm the result.
    E.5 End points
    E.5.1Primary end point(s)
    Phase II - Proportion of participants with undetectable minimal residual disease at 6 months post randomisation.
    Phase III - Progression free survival: time from randomisation to first documented evidence of disease progression (as defined by IWCLL criteria) or death from any cause. Participants who do not progress will be censored at the last date they were known to be alive and progression free.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Analysis on the phase II primary endpoint, proportion of participants with undetectable minimal residual disease, will be carried out after 9 and 23 participants have received at least 4 weeks of obinutuzumab treatment and followed up for the MRD response at 6 months post randomisation.

    A formal interim analysis on progression-free survival will be carried out when half the required number of events have been observed (60 events). Final analysis will be carried out when at least 120 participants have progressed and there is sufficient follow up of participants, anticipated to be 3 years after the close of recruitment.
    E.5.2Secondary end point(s)
    Proportion of participants with undetectable MRD assessed at 6 months post randomisation in the obinutuzumab arm will be summarised with 95% confidence intervals reported.

    Overall survival (OS): Cox proportional hazards model will be fitted to analyse time from randomisation until death, adjusting for the minimisation factors. Overall survival curves will be reported by trial arm using Kaplan-Meier methods, and hazard ratios and corresponding 95% confidence intervals will be calculated.

    Treatment-free survival (TFS): Cox proportional hazards model will be fitted to analyse time from randomisation until next treatment or death, adjusting for the minimisation factors. Treatment-free survival curves will be reported by trial arm using Kaplan-Meier methods, and hazard ratios and corresponding 95% confidence intervals will be calculated.

    Response will be assessed at 6 months post randomisation in the obinutuzumab arm, as defined by IWCLL criteria. Response categories and changes in response from previous therapy will be summarised. The proportion of participants achieving a Complete Response (CR+CRi) and an Overall Response (at least a PR) will be summarised with corresponding 95% confidence intervals.

    Progression-free survival and overall survival from date of first documentation of MRD eradication: the analyses to compare PFS and OS for participants who are MRD negative at registration with those who become MRD negative after obinutuzumab consolidation will be the same as those for the randomised treatment groups, with the exception that survival will be calculated from the end date of prior treatment for CLL.

    Duration of MRD negativity for participants who are or become MRD negative: Cox regression analysis will be used to analyse time to MRD relapse for participants who are MRD negative from most recent prior therapy and those who become MRD negative following obinutuzumab consolidation, adjusting for the minimisation factors. MRD relapse survival curves will be reported by trial arm using the Kaplan-Meier methods, and hazard ratios and corresponding 95% confidence intervals will be calculated.

    Safety and toxicity will be assessed by summaries of the AE, AR, SAE, SAR, and SUSAR rates by treatment received and overall, based on the safety population. The suspected relationship to the protocol treatment will be presented along with other causality, outcome and event duration. ARs will be presented by NCI-CTCAE toxicity grade (V4.03). Individual SUSAR/SAR/SAE line listings will be reported by treatment received and MedDRA System Organ class (where applicable). Treatment related mortality rates will be presented by treatment received.

    Quality of life will be summarised using adjusted for baseline mean scores and 95% CIs for all domains of the EORTC QLQ-C30 and CLL specific module, EORTC QLQ-CLL16 for each trial arm, at each assessment time-point and overall. Missing data patterns will be examined carefully, and if missing data patterns suggest data are not missing at random, analyses will also be carried out using multi-level repeated measures and pattern-mixture models, and data summarised using the Standardised Area Under the Curve.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints will be analysed when at least 120 participants have progressed and there is sufficient follow up of participants, anticipated to be 3 years after the close of recruitment, but survival analyses will also be updated at a later as more data becomes available.
    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) 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 Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    No treatment (as standard)
    E.8.2.4Number of treatment arms in the trial1
    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 concerned40
    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 date of collection of the last participant's last data item.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years9
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years9
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days1
    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: 128
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state188
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 188
    F.4.2.2In the whole clinical trial 188
    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)
    Patients who have shown a good response to prior treatment for CLL would not receive any immediate further treatment in standard clinical practice. Participants requiring further therapy after the end of treatment with obinutuzumab within the trial or no consolidation treatment, will be treated in accordance with
    local policy.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-11-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-12
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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