Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-002444-32
    Sponsor's Protocol Code Number:17-122
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-12-11
    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 ConcernedFrance - ANSM
    A.2EudraCT number2017-002444-32
    A.3Full title of the trial
    Maintenance Brentuximab Vedotin (Bv) Following Allogeneic Stem Cell Transplantation for Hodgkin Lymphoma Patient: A Prospective, Multicenter, Phase II Study
    Maintenance Brentuximab Vedotin (Bv) Following Allogeneic Stem Cell Transplantation for Hodgkin Lymphoma Patient: A Prospective, Multicenter, Phase II Study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Maintenance Brentuximab Vedotin (Bv) Following Allogeneic Stem Cell Transplantation for Hodgkin Lymphoma Patient: A Prospective, Multicenter, Phase II Study
    Maintenance Brentuximab Vedotin (Bv) Following Allogeneic Stem Cell Transplantation for Hodgkin Lymphoma Patient: A Prospective, Multicenter, Phase II Study
    A.3.2Name or abbreviated title of the trial where available
    BVALLO
    BVALLO
    A.4.1Sponsor's protocol code number17-122
    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 SponsorCHU CAEN
    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 supportTAKEDA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU CAEN
    B.5.2Functional name of contact pointInvestigateur coordinateur
    B.5.3 Address:
    B.5.3.1Street AddressIHBN - Hématologie
    B.5.3.2Town/ cityCAEN
    B.5.3.3Post code14033
    B.5.3.4CountryFrance
    B.5.4Telephone number231272539
    B.5.6E-mailgac-ac@chu-caen.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 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.3.4Pharmaceutical form Powder and solution for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    Hodgkin Lymphoma Patients
    Hodgkin Lymphoma Patients
    E.1.1.1Medical condition in easily understood language
    Hodgkin Lymphoma Patients
    Hodgkin Lymphoma Patients
    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 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10025319
    E.1.2Term Lymphomas Hodgkin's disease
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To decrease the cumulative incidence of relapse (CIR) rate by15% at 12 months after allogeneic stem cell transplantation (allo-SCT)
    To decrease the cumulative incidence of relapse (CIR) rate by15% at 12 months after allogeneic stem cell transplantation (allo-SCT)
    E.2.2Secondary objectives of the trial
    • To evaluate the Progression free survival (PFS) at 12 months after allo-SCT
    • To evaluate Non-relapse mortality (NRM) at 12 months after allo-SCT
    To evaluate Relapse Graft versus host disease free survival (RGFS) at 12 months after SCT
    • To evaluate the Progression free survival (PFS) at 12 months after allo-SCT
    • To evaluate Non-relapse mortality (NRM) at 12 months after allo-SCT
    To evaluate Relapse Graft versus host disease free survival (RGFS) at 12 months after SCT
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients aged ≥18 or ≤ 65 years
    2. Patients who received allo-SCT for relapse after autologous transplantation for Hodgkin’s lymphoma
    3. Patients who received tandem autologous and allogeneic stem cell transplantation for HL are eligible
    4. Histologically confirmed CD30+ classical Hodgkin lymphoma according to local pathologist (excluding nodular lymphocyte predominant subtype)
    5. Patients with Ann Arbor stage II-III or IV or extranodal localization at relapse post ASCT
    6. Patients who previously received Bv may be included if the duration of response to initial Bv treatment is more than 3 months
    7. Patients who previously received anti-PD1 drugs can be included
    8. Voluntary written informed consent must be given before performance of any study-related procedure 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.
    9. Patients must be covered by a social security system
    10. Female patients is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug
    11. Male patients, even if surgically sterilized, (i.e., status post vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug.
    12. Performance status ≤ 2
    13. Clinical laboratory values as specified below within 7 days before the first dose of study drug:
    -Absolute neutrophil count ≥ 1,000/µL unless there is known hematologic/solid tumor marrow involvement
    -Platelet count ≥ 75,000/ µL unless there is known marrow involvement of the disease
    -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. AST and ALT may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to the presence of hematologic/solid tumor in liver.
    -Serum creatinine must be < 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance > 40 mL/minute.
    -Hemoglobin must be ≥ 8g/dL.
    1. Male or female patients aged ≥18 or ≤ 65 years
    2. Patients who received allo-SCT for relapse after autologous transplantation for Hodgkin’s lymphoma
    3. Patients who received tandem autologous and allogeneic stem cell transplantation for HL are eligible
    4. Histologically confirmed CD30+ classical Hodgkin lymphoma according to local pathologist (excluding nodular lymphocyte predominant subtype)
    5. Patients with Ann Arbor stage II-III or IV or extranodal localization at relapse post ASCT
    6. Patients who previously received Bv may be included if the duration of response to initial Bv treatment is more than 3 months
    7. Patients who previously received anti-PD1 drugs can be included
    8. Voluntary written informed consent must be given before performance of any study-related procedure 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.
    9. Patients must be covered by a social security system
    10. Female patients is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug
    11. Male patients, even if surgically sterilized, (i.e., status post vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug.
    12. Performance status ≤ 2
    13. Clinical laboratory values as specified below within 7 days before the first dose of study drug:
    -Absolute neutrophil count ≥ 1,000/µL unless there is known hematologic/solid tumor marrow involvement
    -Platelet count ≥ 75,000/ µL unless there is known marrow involvement of the disease
    -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. AST and ALT may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to the presence of hematologic/solid tumor in liver.
    -Serum creatinine must be < 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance > 40 mL/minute.
    -Hemoglobin must be ≥ 8g/dL.
    E.4Principal exclusion criteria
    1. Patients with histologically confirmed nodular lymphocyte predominant subtype
    2. Female patient who are both lactating and breast-feeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1 before first dose of study drug
    3. Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to the protocol.
    4. Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of PML
    5. Unstable diabetes mellitus (to avoid uninterpretable FDG-PET scan).
    6. Symptomatic neurologic disease compromising normal activities of daily living or requiring medications
    7. Any sensory or motor peripheral neuropathy greater than or equal to Grade 2
    8. Known history of any of the following cardiovascular conditions
     Myocardial infarction within 2 years of enrollment
     New York Heart Association (NYHA) Class III or IV heart failure(10) (see Appendix 12.2)
     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%
    9. Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose
    10. Patients that have not completed any prior treatment chemotherapy and/or other investigational agents within at least 5 half-lives of last dose of that prior treatment
    11. Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of Bv.
    12. Known human immunodeficiency virus (HIV) positive
    13. Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection
    14. Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
    1. Patients with histologically confirmed nodular lymphocyte predominant subtype
    2. Female patient who are both lactating and breast-feeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1 before first dose of study drug
    3. Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to the protocol.
    4. Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of PML
    5. Unstable diabetes mellitus (to avoid uninterpretable FDG-PET scan).
    6. Symptomatic neurologic disease compromising normal activities of daily living or requiring medications
    7. Any sensory or motor peripheral neuropathy greater than or equal to Grade 2
    8. Known history of any of the following cardiovascular conditions
     Myocardial infarction within 2 years of enrollment
     New York Heart Association (NYHA) Class III or IV heart failure(10) (see Appendix 12.2)
     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%
    9. Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose
    10. Patients that have not completed any prior treatment chemotherapy and/or other investigational agents within at least 5 half-lives of last dose of that prior treatment
    11. Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of Bv.
    12. Known human immunodeficiency virus (HIV) positive
    13. Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection
    14. Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
    E.5 End points
    E.5.1Primary end point(s)
    Cumulative incidence of relapse (CIR) or progression at 12 months after allo-SCT
    Cumulative incidence of relapse (CIR) or progression at 12 months after allo-SCT
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 months
    E.5.2Secondary end point(s)
    • Overall survival at 12 months after SCT
    • Progression free survival at 12 months after allo-SCT
    • Relapse GVH free survival at 12 months after allo-SCT
    • Treatment related mortality at 12 months after allo-SCT
    • Overall survival at 12 months after SCT
    • Progression free survival at 12 months after allo-SCT
    • Relapse GVH free survival at 12 months after allo-SCT
    • Treatment related mortality at 12 months after allo-SCT
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    12 months
    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 No
    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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    3 years
    3 years
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 58
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 58
    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 state58
    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 Decision2017-12-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-07-23
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun Apr 28 04:12:03 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA