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    Summary
    EudraCT Number:2014-004036-19
    Sponsor's Protocol Code Number:Uni-Koeln-1754
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-01-02
    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 ConcernedGermany - PEI
    A.2EudraCT number2014-004036-19
    A.3Full title of the trial
    GHSG-AFM13
    An open-label, randomized, multicenter phase II trial with AFM13 in patients with relapsed or refractory Hodgkin Lymphoma
    GHSG-AFM13
    Eine offene, randomisierte, multizentrische Phase II Studie mit AFM13 bei Patienten mit rezidiviertem oder therapieresistentem Hodgkin Lymphom
    A.4.1Sponsor's protocol code numberUni-Koeln-1754
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02321592
    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 Cologne
    B.1.3.4CountryGermany
    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 supportAffimed GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGerman Hodgkin Study Group
    B.5.2Functional name of contact pointGerman Hodgkin Study Group
    B.5.3 Address:
    B.5.3.1Street AddressGleueler Straße 269-273
    B.5.3.2Town/ cityCologne
    B.5.3.3Post code50935
    B.5.3.4CountryGermany
    B.5.4Telephone number004922147888200
    B.5.5Fax number004922147888188
    B.5.6E-mailghsg@uk-koeln.de
    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 No
    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/3/09/673, OD/046/09
    D.3 Description of the IMP
    D.3.1Product nameRecombinant antibody construct against human CD30 and CD16A
    D.3.2Product code AFM13
    D.3.4Pharmaceutical form Powder for solution for infusion
    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
    Activity of AFM13 in patients with relapsed/refractory Hodgkin lymphoma after failure of standard therapy including the anti-CD30 immunoconjugate brentuximab vedotin (BV). In this heavily pretreated patient group BV results in a response rate of about 70%; but in most patients the duration of the response is rather short. The reported median PFS was 5.6 months. Therefore, there still is a need for a new treatment option in this heavily pretreated, chemotherapy refractory patient group
    E.1.1.1Medical condition in easily understood language
    AFM13 will be investigated in patients still suffering from Hodgkin lymphoma after standard therapy including the antibody brentuximab vedotin.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of tumor response to one 8-week cycle of AFM13
    Selection of one out of three therapeutic regimens of AFM13 for a potential phase III trial
    E.2.2Secondary objectives of the trial
    Further efficacy assessment (regarding secondary endpoints)
    Evaluation of safety and feasibility
    Assessment of patient reported outcomes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with diagnosis of classical HL reconfirmed by histopathology and relapsed or refractory disease after standard therapy including brentuximab vedotin and anti PD1 or PD-L1 antibodies
    - Age: ≥18 years
    - ECOG performance status ≤ 2
    - No major organ dysfunction (except for HL-related organ dysfunction)
    - Measurable site of disease with ≥ 1.5cm diameter which is evaluable by CT/MRI and FDG-avid by PET
    - Completion of prior therapies not less than 4 weeks prior to study entry and, if applicable, an autologous stem cell transplantation (ASCT) at least 3 months prior to study entry
    - Life expectancy > 3 months
    - Signed informed consent
    E.4Principal exclusion criteria
    - Any significant diseases (other than HL) or clinically significant findings including psychiatric and behavioral problems, medical history and/or physical examination findings that would preclude the subject from participation in the study
    - Major organ dysfunction (except for HL-related disorders)
    - History of a previous malignancy ≤ 3 years prior to first dose of study drug except basal or squamous cell carcinoma of the skin, cervical carcinoma in situ or completely resected melanoma in stage TNMpT1
    - Prior allogeneic stem cell transplantation (SCT)
    - Patients receiving systemic corticosteroid treatment in a dose > 10mg daily prednisone equivalents or other chronic systemic immunosuppressive agents within 2 weeks prior to study entry or during study treatment
    - Patients with a history of HIV seropositivity, chronic active hepatitis, or another uncontrolled active infection within 4 weeks prior to study entry
    E.5 End points
    E.5.1Primary end point(s)
    Objective response rate (ORR) including partial responses (PR) and complete responses (CR) to one 8-week cycle of AFM13
    E.5.1.1Timepoint(s) of evaluation of this end point
    Re-Staging after the first 8-week cycle of AFM13
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints:
    - Remission status based on CT/MRI and PET-CT
    - Time to next salvage treatment
    - Progression-free survival (PFS) and overall survival (OS)

    Secondary feasibility and safety endpoints:
    - Adverse events (AEs) including acute treatment-associated toxicities
    - Premature termination of per-protocol treatment
    - Quality of Life (QoL)-score
    - Anti-drug antibody titers as parameter for immunogenicity (ADAs)

    Secondary exploratory endpoints:
    - Biomarkers
    - AFM13 serum levels
    E.5.2.1Timepoint(s) of evaluation of this end point
    Remission status based on CT/MRI and PET-CT - After first 8-week cycle of AFM13
    Time to next salvage treatment - continuously during follow-up (at least for 1 year)
    Progression-free survival (PFS) and overall survival (OS) - continuously during follow-up (at least for 1 year)

    Adverse events (AEs) including acute treatment-associated toxicities - continuously during treatment
    Premature termination of per-protocol treatment - continuously during treatment
    Quality of Life (QoL)-score - before and after treatment, after 1 year of follow-up
    Anti-drug antibody titers as parameter for immunogenicity (ADAs) - Pre-dose, always on the day of the first AFM13 dose per week in Cycle 1: Weeks 1, 2, 3, 5, 8 (if Cycle 2: Week 8)

    Biomarkers - s. ADAs
    AFM13 serum levels - pre-dose
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Information not present in EudraCT
    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 Yes
    E.8.1.7.1Other trial design description
    Simon’s two-stage design with two cohorts
    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 concerned15
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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.1.3Elderly (>=65 years) Yes
    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 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 state49
    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)
    Recommendations for follow-up visits and a respective schedule is provided in the trial protocol. During follow-up visits are scheduled in three-monthly intervals. Thereafter further visits will be discussed and agreed on between the treating physician and the patient based on current national guidelines. In case of progressive or relapsed disease further care depends on patients choice after being informed by his treating physician and the GHSG trial center on available options at that time.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation German Hodgkin Study Group
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-04-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-01-31
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