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    Summary
    EudraCT Number:2011-001240-29
    Sponsor's Protocol Code Number:C25002
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-01-12
    Trial results View 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2011-001240-29
    A.3Full title of the trial
    A Phase 1/2 Study of Brentuximab Vedotin (SGN-35) in Pediatric Patients With Relapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Brentuximab Vedotin in Children and Adolescents With Relapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma
    A.4.1Sponsor's protocol code numberC25002
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/59/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMillennium Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMillennium Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMillennium Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointJeanenne Chung (Project Manager)
    B.5.3 Address:
    B.5.3.1Street Address40 Landsdowne Street
    B.5.3.2Town/ cityCambridge, Massachusetts
    B.5.3.3Post code02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number+16174443331
    B.5.5Fax number+16174442399
    B.5.6E-mailjeanenne.chung@mpi.com
    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 Pharma A/S, Langebjerg 1, DK-4000 Roskilde, Denmark
    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/3/08/596
    D.3 Description of the IMP
    D.3.1Product nameAdcetris
    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.3.9.2Current sponsor codeSGN-35
    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
    Relapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma
    E.1.1.1Medical condition in easily understood language
    Rare blood cancer requiring treatment
    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 LLT
    E.1.2Classification code 10020328
    E.1.2Term Hodgkin's lymphoma
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10065864
    E.1.2Term Anaplastic large-cell lymphoma, primary systemic type
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 1:
    •To assess the safety profile and determine the pediatric maximum tolerated dose and/or recommended phase 2 dose of brentuximab vedotin
    •To assess the pharmacokinetics of brentuximab vedotin

    Phase 2:
    •To determine the overall response rate (complete remission, partial remission) with brentuximab vedotin at the recommended phase 2 dose
    E.2.2Secondary objectives of the trial
    Phase 1:
    •To determine the immunogenicity of brentuximab vedotin
    •To determine the overall response rate (complete remission, partial remission) with brentuximab vedotin
    •To determine the time to progression, time to response, duration of response, and event-free, progression-free, and overall survival with brentuximab vedotin

    Phase 2:
    •To determine the time to progression, time to response, duration of response, and event-free, progression-free, and overall survival with brentuximab vedotin
    •To assess the pharmacokinetics and safety profile of brentuximab vedotin
    •To determine the immunogenicity of brentuximab vedotin

    Phase 2 Exploratory Objectives
    The exploratory objective in phase 2 is:
    . To assess immmune reconstitution
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients aged 2 to < 18 years (5 to < 18 years for patients with HL).
    2. Have a diagnosis of systemic anaplastic large-cell lymphoma, or Hodgkin lymphoma
    for which standard, curative, life-prolonging, or palliative treatment does not exist or
    is no longer effective. (Patients diagnosed with any relapsed or refractory CD30+
    hematological malignancy [eg, primary mediastinal B-cell lymphoma] may be
    included in phase 1 of the study.)
    3. Patients with sALCL must have documented anaplastic lymphoma kinase (ALK)
    status.
    4. Patients with HL must be in their second or later relapse, have failed systemic
    chemotherapy either as induction therapy for advanced stage disease or salvage therapy, and were ineligible for, refused, or previously received a stem cell
    transplant.
    5. Patients with relapsed or refractory sALCL must be beyond first remission or
    refractory to front-line chemotherapy.
    6. Performance score ≥ 60 from Lansky Play Performance Scale if ≤ 16 years
    7. Female patients who:
    . Are surgically sterile, OR
    . If they are 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, or
    . • Agree to practice true abstinence, when this is in line with the
    preferred and usual lifestyle of the subject. (Periodic abstinence [eg,
    calendar, ovulation, symptothermal, postovulation methods] and
    withdrawal are not acceptable methods of contraception.)
    8. Male patients, even if surgically sterilized (ie, status postvasectomy),
    who:
    • Agree to practice effective barrier contraception during the entire
    study treatment period and through 6 months after the last dose of
    study drug, or
    • Agree to practice true abstinence, when this is in line with the
    preferred and usual lifestyle of the subject. (Periodic abstinence [eg,
    calendar, ovulation, symptothermal, postovulation methods for the
    female partner] and withdrawal are not acceptable methods of
    contraception.)
    9. Voluntary written consent (and institution-specific assent as appropriate based upon
    patient comprehension) must be given before performance of any study-related
    procedure not part of standard medical care, with the understanding that
    consent/assent may be withdrawn by the patient or patient guardian at any time
    without prejudice to future medical care.
    10. Suitable venous access for the study-required procedures.
    11. Clinical laboratory values as specified below within 4 days before
    the first dose of study drug:
    • Absolute neutrophil count greater than or equal to 1,500/μL.
    • Platelet count greater than or equal to 75,000/μL.
    • Serum bilirubin level less than or equal to 1.5  upper limits of
    normal (ULN) or less than or equal to 3  ULN for patients with an
    indirect hyperbilirubinemia due to Gilbert's disease.
    • Serum creatinine less than or equal to 1.5  ULN.
    • Alanine aminotransferase (ALT or SGPT) and aspartate aminotransferase (AST or SGOT) less than or equal to 2.5  ULN. AST and ALT levels may be elevated up to 5  ULN if their elevation can be reasonably ascribed to the presence of metastatic disease in the liver.
    12. Patients must have a radiographically or clinically evaluable tumor per the IWG(1)
    criteria.
    E.4Principal exclusion criteria
    1. Current diagnosis of primary cutaneous ALCL (those with sALCL are eligible).
    2. Received an allogeneic stem cell transplant <3 months prior to first dose of study medication, or presence of polymerase chain reaction (PCR)-detectable CMV in any post allogeneic transplant patient. (Prior PCR positivity that was successfully treated is acceptable provided the baseline PCR result is negative prior to first dose of study drug.)
    3. Receiving immunosuppressive therapy.
    4. Receiving systemic therapy for chronic graft-versus-host disease (topical therapy is
    allowed).
    5. Previous treatment with any anti-CD30 antibody.
    6. Therapeutic monoclonal antibody use within the longer of 6 weeks or 5 plasma halflives.
    7. Symptomatic cardiac disease including ventricular dysfunction, coronary artery
    disease, or arrhythmias, if this would, in the opinion of the investigator or medical
    monitor, interfere with assessment of efficacy or safety of the drug.
    8. History of another primary malignancy not in remission for at least 3 years. (The
    following are exempt from the 3-year limit: nonmelanoma skin cancer and cervical
    carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear)
    9. Known active cerebral/meningeal disease, including signs or symptoms of progressive multifocal leukoencephalopathy (PML) or any history of PML.
    10. History of cirrhosis.
    11. Active systemic viral, bacterial, or fungal infection requiring antimicrobial, antiviral
    therapy or antifungal therapy within 2 weeks prior to first dose of study drug (routine
    antimicrobial prophylaxis is acceptable).
    12. Concurrent therapy with other anti-neoplastic or experimental agents.
    13. Systemic corticosteroid therapy <7 days prior to first dose of study medication.
    14. Any serious underlying medical condition that, in the opinion of the investigator or
    medical monitor, would impair the patient’s ability to receive or tolerate the planned
    treatment.
    15. Known hypersensitivity to recombinant proteins, murine proteins, or any excipient
    contained in the drug formulation.
    16. Received nitrogen mustard agents, melphalan, or BCNU therapy within 6 weeks
    prior to first study dose.
    17. Prior autologous hematopoietic stem cell infusion 4 weeks prior to first study dose.
    18. Grade 2 or greater unresolved toxicity from prior antineoplastic therapy.
    19. Received a strong inhibitor of CYP3A4 < 2 weeks prior to first study dose. (Strong
    inhibitors of CYP3A4 are listed in Appendix 14.4.) (Please refer to the Study Manual for an
    example list of prohibited CYP3A4 inhibitors.)
    20. Grade 2 or greater peripheral neuropathy.
    21. Female patients who are both lactating and breastfeeding, or have a
    positive serum or urine pregnancy test during the screening period or a positive serum or urine pregnancy test on Day 1 before the first dose of study drug.
    22. Received local palliative radiation therapy < 14 days prior to the first dose of study
    medication.
    23. Received radiation therapy to more than 25% of the bone marrow-containing spaces
    < 84 days prior to first dose of study medication.
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1 Primary Endpoints:
    • Adverse events (AEs), serious adverse events (SAEs), assessments of clinical laboratory values, and vital sign measurements
    • Plasma concentrations of brentuximab vedotin, total therapeutic antibody, and MMAE

    Phase 2 Primary Endpoints:
    The primary endpoints in phase 2 include:
    • Best overall response rate (CR, PR) as determined by an IRF using PET, CT, MRI and clinical assessment according to IWG revised response criteria
    E.5.1.1Timepoint(s) of evaluation of this end point
    Does not have a specific timepoint.
    E.5.2Secondary end point(s)
    Phase 1 Secondary Endpoints:
    • Anti-therapeutic antibody (ATA) titer and neutralizing ATA titer
    • Overall response rate (CR, PR) as determined by an independent review facility (IRF) using positron emission tomography (PET), computed tomography (CT), and clinical assessment, according to International Working Group (IWG) revised response criteria
    • Time to progression
    • Time to response
    • Duration of response
    • Event-free survival
    • Progression-free survival
    • Overall survival

    Phase 2 Secondary Endpoints:
    • Time to progression
    • Time to response
    • Duration of response
    • Event-free survival
    • Progression-free survival
    • Overall survival
    • Adverse events, serious adverse events, assessments of clinical laboratory values, and vital sign measurements
    • Plasma concentrations of brentuximab vedotin, total therapeutic antibody, and MMAE
    • Anti-therapeutic antibody (ATA) titer and neutralizing ATA titer

    Phase 1 Secondary Endpoints:
    • Antitherapeutic antibody (ATA) titer and neutralizing ATA titer
    • Best Overall response rate (CR, PR) as determined by an independent
    review facility (IRF) using positron emission tomography (PET),
    computed tomography (CT), magnetic resonance imaging (MRI), and
    clinical assessment, according to International Working Group (IWG)
    revised response criteria
    • Time to progression
    • Time to response
    • Duration of response
    • Event-free survival
    • Progression-free survival
    • Overall survival
    Phase 2 Secondary Endpoints:
    • Time to progression
    • Time to response
    • Duration of response
    • Event-free survival
    • Progression-free survival
    • Overall survival
    • Adverse events, serious adverse events, assessments of clinical
    laboratory values, and vital sign measurements
    • Plasma concentrations of brentuximab vedotin, total therapeutic
    antibody, and MMAE
    • Anti-therapeutic antibody (ATA) titer and neutralizing ATA titer
    E.5.2.1Timepoint(s) of evaluation of this end point
    Does not have a specific timepoint.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity and biomarker analysis
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Pediatric dose-finding
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA84
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belgium
    Brazil
    Canada
    China
    Czech Republic
    Denmark
    France
    Germany
    Hong Kong
    Hungary
    Italy
    Korea, Republic of
    Netherlands
    Norway
    Poland
    South Africa
    Spain
    Taiwan
    Turkey
    United Kingdom
    United States
    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
    Patients will be followed for PFS and OS every 12 weeks for 12 months after the EOT visit. Thereafter, assessment for OS will continue every 6 months until the sooner of death or study closure or a maximum of 2 years after enrollment of the last patient. Patients who remain on treatment after Cycle 16 will be followed according to the Protocol schedule or until study closure.
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months3
    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: 42
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 14
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 28
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Ensure each patient’s parents/legal guardian provides signed and dated informed consent before conducting any study specific procedure
    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 27
    F.4.2.2In the whole clinical trial 42
    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)
    Not different from the expected normal treatment of the condition.
    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 Decision2012-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-17
    P. End of Trial
    P.End of Trial StatusCompleted
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