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    Summary
    EudraCT Number:2013-000734-35
    Sponsor's Protocol Code Number:BRAPP2
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-03-14
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2013-000734-35
    A.3Full title of the trial
    Brentuximab vedotin as consolidation treatment in patients with stage I/II Hodgkin’s lymphoma and FDG-PET positivity after 2 cycles of ABVD
    Brentuximab vedotin en traitement de consolidation chez des patients avec un lymphome de Hodgkin grade I/II et FDG-TEP positif après 2 cycles d'ABVD
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the efficiency of brentuximab vedotin in the Hodgkin lymphoma treatment for the patients not cured by standard chemotherapy.
    Etude de l'efficacité du brentuximab vedotin dans le traitement du lymphome de Hodgkin chez les patients non guéris par la chimiothérapie standard.
    A.3.2Name or abbreviated title of the trial where available
    BRAPP2
    A.4.1Sponsor's protocol code numberBRAPP2
    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 SponsorLYSARC
    B.1.3.4CountryFrance
    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 supportMillennium : The Takeda Oncology Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLYSARC
    B.5.2Functional name of contact pointStéphanie Doyen
    B.5.3 Address:
    B.5.3.1Street AddressCentre Hospitalier Lyon-Sud, Secteur Sainte Eugénie, Pavillon 6D
    B.5.3.2Town/ cityPierre-Bénite cedex
    B.5.3.3Post code69495
    B.5.3.4CountryFrance
    B.5.4Telephone number33472 66 93 33
    B.5.5Fax number33426 07 40 55
    B.5.6E-mailstephanie.doyen@lysarc.org
    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
    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 nameBrentuximab vedotin
    D.3.2Product code SGN-35
    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 INNBRENTUXIMAB VEDOTIN
    D.3.9.1CAS number 914088-09-8
    D.3.9.3Other descriptive nameBRENTUXIMAB VEDOTIN
    D.3.9.4EV Substance CodeSUB32397
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.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
    Patients aged from 18 to 70 years with supradiaphragmatic Ann Arbor clinical stage I or II classical Hodgkin lymphoma CD30+, FDG-PET positive score 4 & 5 according to Deauville criteria after 2 courses of ABVD will be included in the trial.
    E.1.1.1Medical condition in easily understood language
    Patients from 18 to 70 years old, with Hodgkin's lymphoma of poor prognosis
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10020328
    E.1.2Term Hodgkin's lymphoma
    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 19.1
    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
    Evaluation of PFS at 2 years of the Brentuximab vedotin as consolidation treatment in patients with stage I/II Hodgkin’s lymphoma and FDG-PET positivity after 2 cycles of ABVD.
    E.2.2Secondary objectives of the trial
    - Safety and evaluation of toxicities (hematological, neurological, cardiac and pulmonary) of brentuximab vedotin given after radiotherapy
    - CR rate (Cheson 2007) at the end of treatment
    - Overall Survival
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Analysis on tumor tissue biopsy to determine factors that influence treatment reponse based on PET scan assessment and prognosis
    E.3Principal inclusion criteria
    1. Patients must have histologically confirmed CD30+ classical Hodgkin lymphoma
    2. Patients must have provided voluntary written informed consent before performance of any study-related procedures not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
    3. Supradiaphragmatic Ann Arbor clinical stage I or II (favourable and unfavourable according to the EORTC/GELA clinical prognostic factors)
    4. Mandatory FDG-PET/ CT without IV contrast performed at diagnosis
    5. Patients treated with first-line ABVD and FDG-PET positive after 2 cycles (Deauville score 4&5) and without progressive disease
    6. Patients must have an ECOG performance status of 0-2
    7. Life expectancy > 6 months
    8. Patients must be 18-70 years of age
    9. Patients must be available for periodic blood sampling, study-related assessments, and management of toxicity at the treating institution
    10. Clinical laboratory values as specified below before the first dose of study drug:
    • Absolute neutrophil count ≥ 1,500/µL
    • Platelet count ≥ 75,000/ µL Total bilirubin must be < 1.5 x the upper limit of the normal (ULN) unless the elevation is known to be due to Gilbert syndrome
    • ALT or AST must be < 3 x the upper limit of the normal range
    • Serum creatinine must be < 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance > 40 mL/minute
    • Hemoglobin must be ≥ 8g/dL
    11. Patient affiliated to social security system
    E.4Principal exclusion criteria
    1. Patients with dementia or altered mental status that would preclude compliance with drug delivery
    2. Women who are pregnant or breastfeeding
    3. Patients with symptomatic pulmonary disease
    4. Patients with known history of any of the following cardiovascular conditions:
    • Myocardial infarction within 2 years of inclusion
    • New York Heart Association (NYHA) Class III or IV heart failure
    • Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
    • Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction <50%
    5. Any history of cancer or cancer treatment during the last 3 years with the exception of non-melanoma skin cancer or stage 0 (in situ) carcinoma of any type if they have undergone complete resection
    6. Uncontrolled infectious disease, including active HBV infection defined by either detection of HBs Antigen or presence of anti HBc antibody without detectable anti HBs antibody
    7. Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics at the time of inclusion and planned to be still on going within 2 weeks prior to first study drug dose
    8. Known HIV, known or suspected HCV serology positivity
    9. Patients who have been treated previously with any anti-CD30 antibody
    10. Known hypersensitivity to any excipients contained in the brentuximab vedotin formulation
    11. Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of Progressive Multifocal Leukoencephalopathy (PML)
    12. Any sensory or motor peripheral neuropathy greater than or equal to Grade 2
    13. Patients that have not completed any prior treatment chemotherapy, except ABVD, and/or other investigational agents within at least 5 half-lives of last dose of that prior treatment
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is progression-free survival (PFS) according to investigator assessment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation of the PFS at two years.
    PFS is defined as the time from the date of the first cycle of ABVD to the first observation of documented disease progression or death due to any cause. If a subject has not progressed or died, PFS will be censored at the time of last visit with adequate assessment.

    E.5.2Secondary end point(s)
    • To evaluate the safety and tolerability of brentuximab vedotin
    • To analyze overall survival (OS) and CR rate (Cheson 2007) at the end of treatment

    E.5.2.1Timepoint(s) of evaluation of this end point
    • RESPONSE RATE ACCORDING TO THE RESPONSE CRITERIA FOR MALIGNANT LYMPHOMA 2007
    Response rate (Complete Response) will be evaluated after 8 cycles of brentuximab vedotin. Assessment of response will be based on the International Workshop to Standardize Response criteria for NHL (Criteria for evaluation of response in Non-Hodgkin’s lymphoma (Cheson, 2007). Patient without response assessment (due to whatever reason) will be considered as non-responder.
    • OVERALL SURVIVAL (OS)
    Overall survival will be measured from the date of the first cycle of ABVD to the date of death from any cause. Alive patients will be censored at their last follow-up date.
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    The final analysis will be performed when the number of events (9 events) has been reached or at the latest when the last patient will finish follow-up.
    The end of the study is defined as the last patient's last visit and will occur approximately 5 years after the first patient enrolled.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months8
    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: 30
    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 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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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 withdraw from the study treatment or patients who progress / receive new treatment after study treatment period should be followed according the local requirements until death, up to the end of follow-up period. This will only be applicable for patients that have received at least one injection of brentuximab vedotin.
    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 Decision2017-04-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-30
    P. End of Trial
    P.End of Trial StatusOngoing
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