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    Summary
    EudraCT Number:2005-000679-16
    Sponsor's Protocol Code Number:EORTC 06023
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-03-30
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2005-000679-16
    A.3Full title of the trial
    Randomized phase II trial with infliximab (Remicade) in patients with myelodysplastic syndrome and a relatively low risk of developing acute leukemia
    A.4.1Sponsor's protocol code numberEORTC 06023
    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 SponsorEuropean Organisation for Research and Treatment of Cancer
    B.1.3.4CountryBelgium
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Remicade
    D.2.1.1.2Name of the Marketing Authorisation holderCentocor B.V.
    D.2.1.2Country which granted the Marketing AuthorisationCzech Republic
    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 nameRemicade
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNInfliximab
    D.3.9.1CAS number 170277-31-3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typechimeric human-murine IgG1 monoclonal antibody (selective immunosuppressant)
    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 syndrome (MDS)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.1
    E.1.2Level LLT
    E.1.2Classification code 10028533
    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 in MDS patients with ≤ 10% bone marrow (BM) blasts (RA, RARS, RAEB with ≤ 10% BM blasts) the therapeutic activity of two different dosages of infliximab on peripheral blood cell count as well as peripheral and bone marrow (BM) blast cell coun
    E.2.2Secondary objectives of the trial
    To further characterize the subjective and objective toxicity of infliximab in low or intermediate risk MDS patients.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    ♦ Confirmed diagnosis (within one month prior to randomization) of myelodysplasia
    ♦ Bone marrow (BM) blasts ≤ 10 % (corresponding to RA, RARS, RAEB with ≤ 10
    %BM blasts in the FAB classification).
    ♦ Hemoglobin < 10 g/dl or 6.2 mmol/l, or RBC transfusion dependent, and/or
    neutrophil count < 1.5 x 109 /l and/or platelet count < 100 x 109/l or platelet
    transfusion dependent.
    ♦ No poor cytogenetics (complex abnormalities or involvement of chromosome 7) .
    (Patients with unknown cytogenetics could also be included provided
    reasonable efforts have been made for determining the cytogenetic profile
    and the results are considered as a failure – ex: NN with ≤ 10 metaphases).
    ♦ At least 6 weeks prior to randomization without treatment for MDS (including hematopoietic growth factors) other than supportive care only
    ♦ At least 3 months without treatment with any other therapeutic agent targeted at reducing TNF (i.e., pentoxifylline, thalidomide, etanercept etc.) prior to randomization
    ♦ Age ≥ 18 years
    ♦ WHO performance status 0, 1 or 2 (Appendix B)
    ♦ Men and women of childbearing potential must use adequate birth control measures for the duration of the study and should continue such precautions for 6 months after receiving the last infusion.
    ♦ Pregnant or nursing women are not eligible. Women of childbearing potential must have a negative serum pregnancy test performed within 1 week before randomization
    ♦ The patient must be screened for tuberculosis (TB) prior to enrollment. According to the screening patients are considered eligible if the following criteria apply (in chronological order of evaluations to be performed):
    ♦ No current or prior active or latent tuberculosis (TB) irrespective of receiving or
    having received adequate treatment and no recent close contact with an
    individual with active TB
    ♦ A chest X-Ray within 6 weeks prior to randomization shows no evidence of prior
    or current active TB infection such as fibrotic or pleural scaring, pulmonary
    nodules, mediastinal and /or hilar lymphadenopathy, upper lobe volume loss,
    cavitation.
    ♦ Negative intradermal tuberculin skin test within 6 weeks prior to randomisation.
    The performance and interpretation of the test must be done in accordance with
    the guidelines specified in section 3.1 of the protocol
    ♦ Absence of current or prior history of an opportunistic infection (eg. Herpes zoster,
    cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening
    ♦ Absence of other severe (CTCAE grade III-IV) active , chronic or recurrent infections, documented HIV, documented current active hepatitis B or history of a documented hepatitis C
    ♦ No severe cardiac dysfunction (NYHA criteria grade III or IV; see Appendix C) or evidence of congestive heart failure (CHF), or left-ventricular ejection fraction (LVEF) ≤ 35%, or clinical history of CHF
    ♦ No severe pulmonary dysfunction
    ♦ Serum bilirubin ≤ 1.5 X UNL (Upper Normal Limit) and ALAT and ASAT levels ≤ 2.5 X UNL for the institution laboratory
    ♦ Serum creatinine levels ≤ 1.5 X UNL for the institution laboratory
    ♦ No poor medical risk because of other systemic disease
    ♦ No recent history of allergies
    ♦ No previous administration of infliximab or other monoclonal antibodies
    ♦ No history of clinically significant AEs to murine or chimeric proteins or human/murine recombinant products
    ♦ Absence of previous or concurrent cancer with the exception of adequately treated carcinoma in situ of the cervix, non-melanoma skin cancer, and any cancer that has been in remission for more than 5 years
    ♦ Absence of a transplanted solid organ (with the exception of a corneal transplant >3 months prior to screening)
    ♦ Absence of peripheral neuropathy greater than CTCAE grade I, multiple sclerosis or other demyelinating disorder
    ♦ Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
    ♦ Before patient randomization, signed written informed consent must be given according to ICH/GCP, and national/local regulations.
    E.4Principal exclusion criteria
    E.5 End points
    E.5.1Primary end point(s)
    Response rate (CR, PR and HI)
    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 Information not present in EudraCT
    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 Yes
    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) 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.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Information not present in EudraCT
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-03-30. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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)
    Two weeks after the end of study treatment the following examinations need to be performed:
    ♦ Physical examination/vital signs, performance status
    ♦ Biochemistry: serum creatinine, ASAT, ALAT, bilirubin
    ♦ Hematology: hemoglobin, blood cell count including platelets, WBC differential
    ♦ Chest X-ray, ECG
    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 Decision2005-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-04-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-12-14
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