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    Summary
    EudraCT Number:2009-017098-40
    Sponsor's Protocol Code Number:DEC-MDS
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-06-29
    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 ConcernedUK - MHRA
    A.2EudraCT number2009-017098-40
    A.3Full title of the trial
    Use of Decitabine in Myelodysplastic Syndrome (MDS) Following Azacitidine (AZA) Failure (DEC-MDS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to test if decitabine can be used to treat patients with Myelodysplastic Syndrome (MDS) that have already been treated with Azacitidine (AZA)
    A.3.2Name or abbreviated title of the trial where available
    DEC-MDS
    A.4.1Sponsor's protocol code numberDEC-MDS
    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 SponsorKing's College London
    B.1.3.4CountryUnited Kingdom
    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 supportJanssen Cilag
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College Hospital
    B.5.2Functional name of contact pointDepartment of Haematology
    B.5.3 Address:
    B.5.3.1Street Address3rd Floor Bessemer Wing
    B.5.3.2Town/ cityLondon, Denmark Hill
    B.5.3.3Post codeSE5 9RS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+440203299 1183
    B.5.6E-mailLorraine.Catt@kch.nhs.uk
    B.Sponsor: 2
    B.1.1Name of SponsorKing's College Hospital NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 supportJanssen Cilag
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College Hospital
    B.5.2Functional name of contact pointDepartment of Haematology
    B.5.3 Address:
    B.5.3.1Street Address3rd Floor Bessemer Wing
    B.5.3.2Town/ cityDenmark Hill, London
    B.5.3.3Post codeSE5 9RS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+440203299 1183
    B.5.6E-maillorraine.catt@nhs.net
    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.2.1.1.1Trade name Dacogen
    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/3/03/135, EU/3/06/370
    D.3 Description of the IMP
    D.3.1Product nameDECITABINE
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDACOGEN
    D.3.9.1CAS number 2353-33-5
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.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
    Myelodysplastic Syndromes
    Acute Myeloid Leukaemia
    Chronic Myelomonocytic Leukaemia
    E.1.1.1Medical condition in easily understood language
    Blood disorders
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10054350
    E.1.2Term Chronic myelomonocytic leukemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10000886
    E.1.2Term Acute myeloid leukemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10000880
    E.1.2Term Acute myeloid leukaemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10028533
    E.1.2Term Myelodysplastic syndrome
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10009018
    E.1.2Term Chronic myelomonocytic leukaemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the overall response rate (CR+PR as per IWG 2006) at 6 months in MDS patients, CMML-2 patients, and AML patients with up to 30% bone marrow blasts (previously classified as RAEB-t by the FAB MDS classification), treated with low-dose decitabine who have previously failed therapy with 5-azacitidine.
    E.2.2Secondary objectives of the trial
    To assess overall survival.
    To assess time to AML progression or death.
    To assess haematological improvement.
    To assess transfusion requirements.
    To assess cytogenetics response.
    To assess grade 3 and 4 treatment related toxicity
    To assess additional cytogenic markers: DNA methylation status, markers of apoptosis, change in gene expression and Single Nucleotide Polymorphism Profiles.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written signed informed consent.
    2. 18 years of age or older
    3. At study entry, diagnosed MDS with 5% or more marrow blasts and IPSS risk intermediate 2 or high risk; or chronic myelomonocytic leukemia (CMML-2); or AML with 20-30% bone marrow blasts (previously defined as RAEB-t by the FAB MDS classification).
    4. Patients who have failed therapy with azacitidine* see definition below.
    5. Performance status 0-2 (ECOG scale).
    6. Adequate hepatic (bilirubin < 1.5 X ULN or AST< 2.5 X ULN) and renal functions (creatinine <1.5 X ULN).


    *Failure of treatment with 5-azacitidine is defined as:

    1. Refractory
    Progression, immediately and without reaching prior response (CR, PR, mCR, HI), under therapy with 5-azacitidine given for at least 6 cycles

    2. Relapsed on therapy
    Progression, after prior response (CR, PR, mCR, HI, SD), under therapy with 5-azacitidine

    3. Relapsed off therapy
    Patients who had previously attained a response (CR, PR, mCR, HI, SD) while on 5-azacitidine, but have subsequently relapsed within 3 months from last 5-azacitidine course

    4. Toxicity failure
    5-azacitidine-related non-haematological toxicity precluding its further administration
    E.4Principal exclusion criteria
    1. Patients with >30% bone marrow blasts at study entry.
    2. Nursing and pregnant females.
    3. Women of childbearing potential (WCBP) † and males not willing to practice an effective method of contraception whilst receiving decitibine and for 2 months after the last infusion.
    † A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or bilateral oopherectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses at any time in the preceding 24 consecutive months).
    4. Patients with concurrent malignancy.
    5. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure and unstable angina pectoris.
    6. Ongoing oral corticosteroids are not permitted. However, use of corticosteroids (topical and inhaled) is permitted and prophylactic steroids are allowed for transfusion reactions.
    7. Patients who have received any investigational agent within the 30 days preceding the first dose of study drug.
    8. Patients who have received prior intensive combination chemotherapy or high-dose cytarabine (>/= 1g/m*2 per dose) for the treatment of MDS or AML. (Prior biologic therapies, targeted therapies and single agent chemotherapy are allowed).
    9. Patients who have an active viral or bacterial infection. Note: No patient is allowed to enter the study unless infections have been fully treated and the patient has remained afebrile for 7 days without antibiotics.
    10. Patients who have concurrent autoimmune hemolytic anemia or immune thrombocytopenia.
    11. Patients who have previously been treated with decitabine.
    12. Patients who have known positive serology for HIV.
    13. Patients with a condition that may be unable to comply with the treatment and monitoring requirements of the study.
    E.5 End points
    E.5.1Primary end point(s)
    Overall Response Rate
    E.5.1.1Timepoint(s) of evaluation of this end point
    Duration of response is defined as the interval from date complete or partial remission is documented to date of recurrence/progression, death due to any cause, or lost to follow-up.
    E.5.2Secondary end point(s)
    1) Overall survival
    2) Time to AML
    3) Hematologic Improvement
    Hematologic improvements (HI) must last at least 2 months in the absence of ongoing cytotoxic therapy). Hematologic improvement should be described by the number of individual, positively affected cell lines (e.g., HI-E; HI-E + HI-N; HI-E + HI-P + HI-N).
    4) Erythroid response (HI-E) Hgb increase by 1.5 g/dL.
    5) Platelet response (HI-P)
    Absolute increase of 30 x 109/L for patients starting with > 20 x 109/L platelets. Increase from < 20 x 109/L to > 20 x 109/L and by at least 100%.
    6) Neutrophil response (HI-N)
    At least 100% increase and an absolute increase > 0.5 x 109/L.
    7) Transfusion requirements
    Transfusion requirements will be recorded for each patient for the 8-week period before first dose of study drug and during the trial. To be considered transfusion independent, patients must not have received transfusions or medications to stimulate production ofred or white blood cells or platelets for a period of 8 weeks.
    8) Cytogenetic Response Rate
    Cytogenetic response requires 20 analyzable metaphases using conventional cytogenetic techniques.
    9) Treatment Related Toxicity
    Toxicity will be scored using CTC Version 3.0 for toxicity and adverse event reporting.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Overall survival is defined as the date of first dose of study drug to the date of death from any cause.
    2) Time to AML is defined as the date of the first dose of study drug to the first date that the patient is confirmed to have AML (≥20% blasts in bone marrow)
    3) 30 days post last dose
    4) 30 days post last dose
    5) 30 days post last dose
    6) 30 days post last dose
    7) 30 days post last dose
    8) 30 days post last dose
    9) 30 days post last 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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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 concerned7
    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
    last visit of the last subject undergoing the trial
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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 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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    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)
    Routine 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 Decision2010-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-08-14
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