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    Summary
    EudraCT Number:2016-000327-10
    Sponsor's Protocol Code Number:SAMBA
    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:2016-07-05
    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 number2016-000327-10
    A.3Full title of the trial
    SINGLE AGENT JNJ-56022473 IN MDS AND AML PATIENTS FAILING HYPOMETHYLATING AGENT BASED THERAPY
    Untersuchung der Wirksamkeit des Antikörpers JNJ-56022473 bei MDS- und AML-Patienten, welche refraktär und/oder rezidiviert auf hypomethylierende Substanzen reagieren.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation of efficacy of the antibody JNJ-56022473 in MDS and AML patients, in which the treamtment with hypomethylating agents fails or the treatment with hypomethylating agents results in a relapse.
    Untersuchung der Wirksamkeit des Antikörpers JNJ-56022473 bei MDS- und AML-Patienten, welche nicht auf eine Behandlung mit hypomethylierende Substanzen anschlagen bzw. welche durch die Behandlung mit hypomethylierenden Substanzen ein erneutes Auftreten der Krankheit aufzeigen.
    A.3.2Name or abbreviated title of the trial where available
    SAMBA-trial
    A.4.1Sponsor's protocol code numberSAMBA
    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 SponsorGWT-TUD GmbH
    B.1.3.4CountryGermany
    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 supportJanssen Pharmaceutica NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGWT-TUD GmbH
    B.5.2Functional name of contact pointMedical Consulting
    B.5.3 Address:
    B.5.3.1Street AddressBlasewitzer Straße 43
    B.5.3.2Town/ cityDresden
    B.5.3.3Post code01309
    B.5.3.4CountryGermany
    B.5.4Telephone number49035125933193
    B.5.5Fax number49035125933198
    B.5.6E-mailmartin.puttrich@gwtonline.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameJNJ-56022473 (CSL362) 100 mg
    D.3.2Product code JNJ-56022473 (CSL362) 100 mg
    D.3.4Pharmaceutical form Concentrate 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) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    AML and MDS patients failing or being refractory to hypomethylating agent (HMA) treatment.
    Patienten mit MDS oder AML, welche nicht auf die Behandlung mit hypomethylierenden Substanzen ansprechen bzw. ein Rezidiv der Krankheit zeigen.
    E.1.1.1Medical condition in easily understood language
    Patients with MDS or AML, who are failing hypomethylating agents.
    Patienten mit MDS oder AML, welche nicht auf die Behandlung mit hypomethylierenden Substanzen ansprechen bzw. ein Wiederauftreten der Krankheit erfahren.
    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 LLT
    E.1.2Classification code 10000886
    E.1.2Term Acute myeloid leukemia
    E.1.2System Organ Class 100000012984
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10067096
    E.1.2Term 5q minus myelodysplastic syndrome
    E.1.2System Organ Class 100000074219
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of JNJ-56022473 for the treatment of MDS and AML patients who have relapsed after or are refractory to treatment with HMAs
    E.2.2Secondary objectives of the trial
    Safety, quality of life, PD, AML evolution, progression
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Signed informed consent
    - ≥ 18 years of age
    - Must be able to adhere to the study visit schedule and other protocol requirements
    - Diagnosis of AML or MDS
    - At least ≥ 5% BM blasts at the time of screening (done by central morphology)
    - At least one cytopenia (ANC < 1800/µL or platelet count < 100,000/µL or hemoglobin < 10 g/dL)
    - Failure to achieve complete or partial response or hematological improvement after at least six (azacitidine) or four (decitabine) 4-week treatment cycles administered during the past two years OR
    - Relapse after initial complete or partial response or hematological improvement observed after at least six (azacitidine) or four (decitabine) 4-week treatment cycles administered during the past two years OR
    - Intolerance to treatment with HMAs defined by drug-related ≥ Grade 3 liver or renal toxicity leading to treatment discontinuation during the past two years
    -Failed to respond to, relapsed following, not eligible, or opted not to participate in bone marrow transplantation
    -Off all other treatments for AML/MDS for at least four weeks; Filgrastim (G-CSF) and erythropoietin are allowed before and during the study as clinically indicated
    - No medical need for or patient opted not to receive induction chemotherapy
    - ECOG performance status of 0-2
    - Willing to adhere to the prohibitions and restrictions specified in the protocol
    E.4Principal exclusion criteria
    - Previous treatment with a CD123 agent or T- or NK cell redirecting therapy
    - Patients having received intensive chemotherapy to treat HMA failure
    - Diagnosis of acute APL
    - WBC > 15 GPT/L
    - Any active malignancy within the past year, except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast
    - Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
    - Active infection not adequately responding to appropriate therapy
    - Subjects with autoimmune disease with either a chronic (viral, bacterial, or fungal) infection, a prior history of recurrent serious infection, or a clinically important active infection
    - Subjects who have a history of human immunodeficiency virus (HIV) or any uncontrolled active systemic infection requiring IV antibiotics or have active systemic hepatitis infection requiring treatment or other clinically active liver disease
    - Total bilirubin > 1.5 mg/dL not related to hemolysis or Gilbert’s disease
    - ALT/AST > 2.5 x upper limit of normal
    - Serum creatinine > 2.0 mg/dL
    - Female patients who are pregnant or lactating
    - Patients who are unwilling to follow highly effective contraception requirements (including condom use for males with sexual partners, and for females: prescription of oral contraceptives, contraceptive injections, intrauterine device, contraceptive patch, surgical sterilization or true sexual abstinence) at least at screening, throughout the study and within 3 months after last study drug administration.
    - Female patients with child-bearing potential who do not have a negative urine β-HCG pregnancy test at screening and prior to the first study drug administration at visit 1 (day 0) of the JNJ-56022473 treatment period
    - Known hypersensitivity to the study drugs or active substances or excipients of the preparations
    - Suspicion of drug or alcohol abuse
    - Subject is in custody by order of an authority or a court of law
    - Participation in another clinical study during the preceding 3 months (last treatment from previous study to first treatment of this study)
    - Exclusion periods from other studies or simultaneous participation in other clinical studies
    - Treatment with any investigational drug within 4 weeks before first administration of present trial drug or within less than 5 half-lives of the investigational drug before treatment with the present trial drug, whichever is longer.
    - Criteria which in the opinion of the investigator precluded participation for scientific reasons, for reasons of compliance, or for reasons of the subject’s safety
    - Previous assignment to treatment during this study
    - Close affiliation with the investigational site; e.g. a close relative of the investigator, dependent person (e.g. employee or student of the investigational site)
    - Subject is an employee of GWT-TUD GmbH
    E.5 End points
    E.5.1Primary end point(s)
    - Overall hematological response rate at 3 months (either CR, PR, marrow-CR, HI, SD)
    E.5.1.1Timepoint(s) of evaluation of this end point
    - LPLV
    E.5.2Secondary end point(s)
    - Toxicity as measured by NCI CTCAE 4.03
    - Overall survival at 1 year
    - Progression-free-survival at 1 year
    - Overall hematological response rate at 12 months (either CR, PR, marrow-CR, HI, SD). Remission assessment according to Döhner et al. (AML patients) [20] and Cheson et al. (MDS patients) [21]
    - Quality of life as measured by EORTC-QLQ30
    - Time to treatment failure
    - Duration of response (best overall response)
    - Association of response to molecular signature and immune cell function (additional translational project)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - 1 year after enrollment
    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.8.3 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    - Last Patient Last Visit or Maximum 12 months Follow-Up after enrollment and after database cleaning.
    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 months37
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months37
    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: 43
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 43
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 43
    F.4.2.2In the whole clinical trial 43
    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)
    After conclusion of the clinical trial, patients will receive further standard medical care at the discretion of the treating physician.
    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 Decision2016-11-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-07-15
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