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    Summary
    EudraCT Number:2012-000214-11
    Sponsor's Protocol Code Number:RG_11-225
    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:2013-06-07
    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 number2012-000214-11
    A.3Full title of the trial
    BREVITY: A phase II study of brentuximab vedotin using a response adapted design in patients with Hodgkin lymphoma unsuitable for chemotherapy due to age, frailty or co-morbidity
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of brentuximab vedotin in patients with Hodgkin lymphoma who are unsuitable for chemotherapy
    A.3.2Name or abbreviated title of the trial where available
    BREVITY: Brentuximab vedotin in patients with Hodgkin lymphoma
    A.4.1Sponsor's protocol code numberRG_11-225
    A.5.4Other Identifiers
    Name:Sponsors SAF numberNumber:ERN_11-0718
    Name:Sponsors RG NumberNumber:RG_11-225
    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 Birmingham
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Birmingham
    B.5.2Functional name of contact pointKathryn Paterson
    B.5.3 Address:
    B.5.3.1Street AddressCRCTU, School of Cancer Sciences
    B.5.3.2Town/ cityEdgbaston, Birmingham
    B.5.3.3Post codeB15 2TT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01214147673
    B.5.5Fax number01214143700
    B.5.6E-mailbrevity@trials.bham.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 Adcetris
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Global Research and Development Centre (Europe) 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 Yes
    D.2.5.1Orphan drug designation numberEU/3/11/939
    D.3 Description of the IMP
    D.3.1Product nameBrentuximab vedotin
    D.3.2Product code SGN-35
    D.3.4Pharmaceutical form Powder for solution for injection
    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 INNBrentuximab Vedotin
    D.3.9.1CAS number 914088-09-8
    D.3.9.3Other descriptive nameSGN-35
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) 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
    Hodgkin lymphoma
    E.1.1.1Medical condition in easily understood language
    Hodgkin lymphoma is a cancer of lymph tissue found in the lymph nodes, spleen, liver, bone marrow, and other sites.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10020261
    E.1.2Term Hodgkin's disease NOS stage II
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10020270
    E.1.2Term Hodgkin's disease stage III
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10020269
    E.1.2Term Hodgkin's disease stage II
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10061597
    E.1.2Term Hodgkin's disease stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10020265
    E.1.2Term Hodgkin's disease NOS stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10020264
    E.1.2Term Hodgkin's disease NOS stage III
    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
    To determine how many patients treated with 4 cycles of brentuximab vedotin, who are unsuitable for conventional chemotherapy, have a complete response to the treatment (as measured by PET scan Deauville score 1,2 or 3).
    E.2.2Secondary objectives of the trial
    • Determine tolerability in terms of toxicity, number of doses of brentuximab vedotin administered, dose reductions and treatment delays.
    • How many patients have a positive response after 4 cycles using a different response criteria called the revised response criteria
    • Determine how long patients survive without disease progression
    • Determine the overall survival and cause of death in these patients
    • How many patients have a positive response after 2 cycles, using a blinded PET CT scan
    • To determine if you can predict positive responses earlier in treatment by correlating responses after 2 cycles (blinded PET) to the responses after 4 cycles, and of end treatment, progression free and over all survival
    • Assess the profile of co-morbidities in the patient group
    • Collate reported performance status using the CIRS-R score
    • Collate information on alternative and additional treatments administered following treatment with brentuximab vedotinin
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Collection of diagnostic tissue from Paraffin Blocks. To create a tissue micro array to be stored for future use in the Manchester Cancer Research Center biobank.
    Blood sample collection. To be stored for use in future correlative studies in the Manchester Cancer Research Center biobank.
    E.3Principal inclusion criteria
    1. Histologically confirmed CD30 positive classical Hodgkin lymphoma
    2. No previous treatment for classical Hodgkin lymphoma
    3. Aged more than or equal to 16 years
    4. Stages II (with B symptoms, extranodal disease, bulky disease, ≥3 sites of nodal involvement, fewer than 3 sites of nodal involvement but unsuitable for radiotherapy because of anatomical distribution or ESR ≥50 mm/h), III and IV classical Hodgkin lymphoma
    5. Any of the following:
    At any age, standard chemotherapy considered inappropriate because:
    a. Impaired cardiac function defined either by an ejection fraction of less than 50% assessed by echocardiogram or nuclear medicine scan (MUGA)
    b. Left ventricular ejection fraction ≥50% measured by MUGA or echocardiography but in the presence of significant co-morbidities or cardiac risk factors such as diabetes mellitus, hypertension, peripheral vascular disease, ischaemic heart disease, previous myocardial infarction, obesity, stroke or transient ischaemic attacks (TIA) that make anthracycline-containing chemotherapy inadvisable as determined by the treating physician.
    c.Heart failure clinically determined by the presence of New York Heart Association (NYHA) heart failure grade II and III due to a cause other than HL
    d.Impaired respiratory function with DLCO and/or FVC/FEV1 ratio less than 75% of predicted due to a cause other than HL

    For patients aged 60 years or older,
    e. an ECOG score of 1, 2 or 3 for any reason, before the start of permitted steroids and considered unsuitable for treatment with standard chemotherapy by the supervising physician.

    6. FDG avid disease
    7. Measurable disease with at least one lesion measuring 1.5 cm in short axis diameter
    8. Written informed consent
    9. Able to comply with requirements of the protocol (including PET scans)
    10. Agree and be able to use adequate contraception if required
    E.4Principal exclusion criteria
    1. Nodular lymphocyte predominant Hodgkin lymphoma
    2. Grade 2 or worse peripheral neuropathy
    3. Haemoglobin <9 g/dl (transfusion allowed)
    4. Unsupported neutrophil count <1.0 x 10-9/l and platelet count <100 x 10-9/l unless due to bone marrow infiltration by Hodgkin lymphoma demonstrated by trephine biopsy
    5. Serum bilirubin more than 1.5 times upper limit normal unless due to Hodgkin lymphoma or Gilbert’s syndrome
    6. Creatinine clearance < 30 ml/min (calculated by the modified Cockroft-Gault formula, see appendix) unless due to Hodgkin lymphoma. Patients with an eGFR < 30 ml/min but a measured GFR by other method (e.g. EDTA) of 30ml/min or greater would be eligible.
    7. Pregnant or lactating women
    8. Concurrent metastatic or new diagnosis of malignancy within the last 24 months – except appropriately treated superficial melanoma, basal cell carcinoma and squamous cell carcinoma of the skin, cervical intra-epithelial neoplasia or in situ or organ confined prostate cancer not currently requiring therapy
    9. The use of other investigational or anti-neoplastic agents within the previous 6 weeks or during the trial. Corticosteroids are allowable for immediate relief of symptoms
    10. Known to be HIV, Hep B positive (Hep B Core antibody positive allows inclusion providing surface / core antigen both negative) or Hep C positive (Hep C antibody positive allows inclusion providing PCR for viral RNA is negative).
    11. Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin.
    12. Known cerebral or meningeal involvement by Hodgkin Lymphoma
    13. Symptoms or signs of PML
    14. Any active systemic viral, bacterial, or fungal infection requiring intravenous antibiotics within 2 weeks prior to cycle 1 day 1 of brentuximab vedotin
    15. Evidence of current uncontrolled cardiovascular conditions, including unstable angina and NYHA grade IV
    E.5 End points
    E.5.1Primary end point(s)
    Complete response rate after 4 cycles (12 weeks) of brentuximab vedotin defined as Deauville score of 1, 2 or 3 by PET 4
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 4 cycles of treatment (12 weeks)
    E.5.2Secondary end point(s)
    • Tolerability and dose intensity
    • Overall objective response rate (ORR), including complete or partial response (CR/PR), after 4 cycles of treatment with brentuximab vedotin according to the Revised Response Criteria for malignant lymphoma
    • Progression Free Survival (PFS) where progression is defined according to the Revised Response Criteria for malignant lymphoma
    • Overall survival (OS) and cause of death
    • Deauville score after cycle 2 based on blinded PET2 scan
    • Correlation of Deauville score after 2 cycles (blinded PET2) with Deauville score after 4 cycles (PET 4), end of treatment response, progression-free and overall survival
    • Co-morbidity profile in the study population documented throughout the study
    • CIRS-G profile in the study population assessed at baseline
    • Any additional treatments administered following treatment with brentuximab vedotin
    E.5.2.1Timepoint(s) of evaluation of this end point
    16 cycles of brnetuximab (48 weeks) for the Tolerability/dose intensity.
    4 cycles (12 weeks)for the ORR endpoints.
    5 years for the PFS and OS endpoints and for correlation with the blinded PET.
    2 cycles (6 weeks) for the Deuville score following PET 2.
    Study entry for the co-morbidity and CIRS-G assessments.
    5 years for the additional treatments.
    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 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) 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 concerned14
    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 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
    For the MHRA, the end of trial will be 6 months after the last patient has completed protocol treatment. This will allow sufficient time for the completion of data collection and data input.
    For the REC, the end of trial date will be 6 months after last data capture following either death of all of the trial patients or 5 years of follow up of all patients from cycle 1 day 1, whichever occurs latest.
    A summary report will be provided within 12 months of the end of trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    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 Yes
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 1
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 4
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state30
    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 the participants achieve complete remission at PET 4 they will receive a maximum of 16 cycles of brentuximab vedotin This is the current accepted treatment regimen for brentuximab vedotin. No further brentuximab vedotin will be provided as part of the study and all other treatments offered to participants will be at the discretion of the treating clinician.
    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 Decision2013-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-18
    P. End of Trial
    P.End of Trial StatusOngoing
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