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    Summary
    EudraCT Number:2014-004874-41
    Sponsor's Protocol Code Number:NMDSG14A
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-06-02
    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 ConcernedSweden - MPA
    A.2EudraCT number2014-004874-41
    A.3Full title of the trial
    Safety, Efficacy and Immune Response of Histamine Dihydrochloride and
    Low-dose Interleukin-2 in Chronic Myelomonocytic Leukemia (CMML)
    En studie för att utvärdera effekt och biverkningar av Interleukin-2 och
    Histamin Dihydroklorid vid Kronisk Myelomonocytleukemi (KMML)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate safety and efficiency of treatment with histamine and
    interleukin-2 in chronic myelomonocytic leukemia (CMML)
    En studie för att utvärdera säkerhet och effekt av behandling med histamin
    och IL-2 vid kronisk myelomonocytär leukemi (KMML)
    A.4.1Sponsor's protocol code numberNMDSG14A
    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 SponsorNordic MDS study group
    B.1.3.4CountrySweden
    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 supportNordic MDS study group
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSahlgrenska University Hospital
    B.5.2Functional name of contact pointClinical trials office
    B.5.3 Address:
    B.5.3.1Street AddressBruna stråket 5
    B.5.3.2Town/ cityGothenburg
    B.5.3.3Post code413 45
    B.5.3.4CountrySweden
    B.5.4Telephone number+4631342 7344
    B.5.5Fax number+4631820269
    B.5.6E-maillars.mollgard@vgregion.se
    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 Ceplene
    D.2.1.1.2Name of the Marketing Authorisation holderMeda AB
    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/3/05/272
    D.3 Description of the IMP
    D.3.1Product nameCeplene
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHistamin dihydrochloride
    D.3.9.3Other descriptive nameHISTAMINE DIHYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB12022MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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.IMP: 2
    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 Proleukin
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharmaceuticals UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameProleukin
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNaldesleukin
    D.3.9.1CAS number 110942-02-4
    D.3.9.3Other descriptive nameALDESLEUKIN
    D.3.9.4EV Substance CodeSUB05303MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/kg microgram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Chronic myelomonocytic leukemia
    E.1.1.1Medical condition in easily understood language
    Chronic myelomonocytic leukemia
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and feasibility of treatment with HDC/IL-2 in
    CMML
    E.2.2Secondary objectives of the trial
    To evaluate the clinical efficacy of HDC/IL-2 treatment in CMML.
    To investigate the immunological effects of HDC/IL-2 in CMML
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • ≥18 years of age at the time of signing the informed consent form.
    • CMML-1 with indication for treatment according to NMDSG
    guidelines*.
    • Life expectancy of more than three months and ability to undergo
    routine outpatient evaluations for efficacy, safety, and compliance.
    • Informed consent obtained and signed.
    E.4Principal exclusion criteria
    • Acute myeloid leukemia.
    • CMML-2 according to WHO criteria.
    • Systemic mastocytosis.
    • Previous or intended allogeneic stem cell transplantation.
    • Concomitant or intended cytostatic or cytoreductive therapy other
    than hydroxyurea (HU) *.
    • ECOG performance status ≥3.
    • Platelet count (TPK) <30x109/L
    • NYHA class III or IV cardiac disease, hypotension or severe
    hypertension, vasomotor instability, serious or uncontrolled cardiac
    dysrhythmias (including ventricular arrhythmias) at any time, acute
    myocardial infarction within the past 12 months, angina pectoris or
    symptomatic arteriosclerotic blood vessel disease.
    • Other active malignancies except in situ carcinoma of the cervix,
    localized squamous or basal cell carcinoma of the skin.
    • Serious concurrent or recent non-malignant medical conditions which,
    in the opinion of the Investigator, makes the patient unsuitable for
    participation in this study.
    • History of seizures, central nervous system disorders, stroke within
    the last 12 months, or psychiatric disability thought to be clinically
    significant in the opinion of the Investigator and adversely affecting
    compliance to protocol.
    • Serum creatinine > 1.5 times the upper normal limit.
    • Serum aminotransferase (AST), alanine transaminase (ALT) and
    bilirubin >2.0 times the upper normal limit
    • Active autoimmune disease (including but not limited to systemic
    lupus, inflammatory bowel disease, and psoriasis).
    • Patients with active peptic or esophageal ulcer disease or with past
    peptic ulcer or esophageal disease with a history or bleeding.
    • Patients requiring active treatment for hypotension.
    • Patients continuing systemic treatment with clonidine, steroids,
    and/or H2
    receptor blocking agents.
    • Patients with a history of histamine hypersensitivity, severe allergies
    to food or contrast media requiring treatment within the last five years.
    • Pregnancy. Women of childbearing potential (WCBP) and males
    having intercourse with WCBP must agree to comply with using an
    effective contraceptive method for the duration of the treatment (WCBP
    is a sexually mature woman who is not surgically sterile or has not been
    naturally postmenopausal for at least 12 consecutive months).
    • Nursing
    * Note that treatment with HU is allowed if treatment has been ongoing
    for at least 3 months prior to enrollment. The use of HU is also allowed
    to control myeloproliferation after starting study treatment, preferably
    during resting periods Please refer to section 9.
    E.5 End points
    E.5.1Primary end point(s)
    • Adverse events as defined by CTCAE v4.03.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Continuously from starting treatment until 30 days after end of
    treatment
    E.5.2Secondary end point(s)
    • Clinical response and hematological improvement, and durations
    thereof, according to IWG criteria for MDS/MPN
    • Changes in size, genotype and phenotype of the malignant
    populations.
    • Correlation between genetic aberrations and clinical response.
    • The quantitative and qualitative effects of HDC/IL-2 on immune cell
    phenotypes and function.
    • Disease progression according to IWG criteria for MDS/MPN(1).
    • Transformation to AML.
    • Allo-SCT.
    • Survival.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety endpoints will be assessed continuously from starting treatment
    until 30 days after end of treatment. Efficacy and immunological
    endpoints will be evaluated after 4 and 10 treatment cycles.
    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 Yes
    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) 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
    First time in sujects with CMML
    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 concerned4
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 7
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state15
    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)
    None (regular care)
    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 Decision2016-07-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-20
    P. End of Trial
    P.End of Trial StatusOngoing
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