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    Summary
    EudraCT Number:2008-000470-21
    Sponsor's Protocol Code Number:JNJ-30979754
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-05-29
    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 ConcernedFrance - ANSM
    A.2EudraCT number2008-000470-21
    A.3Full title of the trial
    A Phase II study of Decitabine in patients with
    Chronic Myelomonocytic Leukemia
    A.3.2Name or abbreviated title of the trial where available
    GFM-DEC-LMMC-2007-02
    A.4.1Sponsor's protocol code numberJNJ-30979754
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGroupe Francophone des Myélodysplasies
    B.1.3.4CountryFrance
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 DACOGEN (decitabine)
    D.2.1.1.2Name of the Marketing Authorisation holderMGI PHARMA, INC
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameDECITABINE
    D.3.2Product code JNJ-30979754
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10009018
    E.1.2Term Chronic myelomonocytic leukaemia
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Hematological response rate at three and six cycles according to the IWG 2006 criteria (modified in case of “proliferative” CMML)
    E.2.2Secondary objectives of the trial
    Response duration
    Time to progression to AML
    Survival
    Clinical and biological toxicity
    Demethylation of LINE repetitive elements
    in vitro and in vivo characterization of the response of two blood monocyte populations to decitabine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients aged 18 and older

    With CMML diagnosis according to WHO criteria

    -Stable excess in blood monocytes, > 1 x 109/L and constituting > 10% WBC

    - Lack of bcr-abl rearrangement (or Philadelphia chromosome)

    - Bone marrow blast cells < 20%

    -Dysplasia of at least one lineage or clonality marker or blood monocytosis during more than 3 months w/o other explanation.

    With :
    If WBC <12 000/mm3 : IPSS high or intermediate 2

    If WBC > or = 12 000/mm3 : at least two of the following criteria
    -Blast cells > 5 % in the bone marrow
    -Clonal cytogenetic abnormality other than t(5;12) (q33; p13)
    -Anemia (Hb < 100 g/L)
    -Thrombocytopenia (platelet count < 100 x 109/L)
    -Splenomegaly > 5 cm below costal margin
    -Extramedullary localization (documented cutaneous, pleural or pericardial effusion, etc…)

    Either untreated or previously treated with
    -Hydrea or Etoposide given orally
    -Non intensive chemotherapy (e.g. low dose cytarabine)
    -Intensive chemotherapy given more than 3 months before inclusion

    With performance status 0-2 on the Eastern Cooperative Oncology Group (ECOG) Scale.

    With estimated life expectancy of at least 12 weeks (this is inherent to ECOG 0-2, and actually very hard to predict/verify, therefore we prefer to take this out)

    With adequate organe function including the following
    -Hepatic : total bilirubin < 1.5 times upper limit of normal (ULN) (except moderate unconjugated hyperbilirubinemia due to intra medullary hemolysis) , alanine transaminase (ALT) and aspartate transaminase (AST) < 3 times ULN

    -Renal : serum creatinine < 1.5 times ULN, creatinine clearance > 30 mL/min

    With informed consent

    With negative pregnancy and adequate contraception if relevant.
    E.4Principal exclusion criteria
    - Myeloproliferative / myelodysplastic syndrome other than CMML

    -Acute blastic transformation of CMML with bone marrow blast cells > 20%

    -Patients eligible for allogeneic bone marrow transplantation with a identified donor

    -CMML with t(5 ;12) or PDGFR rearrangement that could receive imatinib

    -Intensive chemotherapy given within 3 months

    -Previous treatment with a hypomethylating agent

    -Age < 18

    -Pregnant or breastfeeding

    -Performance status > 2 on the ECOG Scale.

    -Estimated life expectancy lower than 12 weeks

    -Serious concomitant systemic disorder, including active bacterial, fungal or viral infection, that, in the opinion of the investigator, would compromise the safety of the patient and/or his/her ability to complete the study.

    -Consent withdrawal
    E.5 End points
    E.5.1Primary end point(s)
    Hematological response rate at three and six cycles according to the IWG 2006 criteria (modified in case of “proliferative” CMML)

    If the treatment has demonstrated efficacy, additional courses will be given with no limitation in number, but a recommendation to administer at least 6 courses after the best response has been reached.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned28
    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 Information not present in EudraCT
    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
    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 months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 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 state41
    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 Decision2008-08-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-24
    P. End of Trial
    P.End of Trial StatusOngoing
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