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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2006-004912-28
    Sponsor's Protocol Code Number:EORTC06061
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-01-03
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2006-004912-28
    A.3Full title of the trial
    Clofarabine in combination with a standard remission induction regimen (AraC and idarubicin) in patients 18-60 years old with previously untreated intermediate and bad risk acute myelogenous leukemia (AML) or high risk myelodysplasia (MDS): a phase I-II study of the EORTC-LG and GIMEMA (AML-14A trial).
    A.3.2Name or abbreviated title of the trial where available
    AML-14A
    A.4.1Sponsor's protocol code numberEORTC06061
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00838240
    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 SponsorEuropean Organisation for Research and Treatment on 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 supportGenzyme Europe B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEuropean Organisation for Research and
    B.5.2Functional name of contact pointMedical Department
    B.5.3 Address:
    B.5.3.1Street Address83/11 av Mounier
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1200
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3227741611
    B.5.5Fax number+3227713545
    B.5.6E-maileortc@eortc.be
    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 Evoltra
    D.2.1.1.2Name of the Marketing Authorisation holderGenzyme Europe B.V.
    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/3/01/082
    D.3 Description of the IMP
    D.3.1Product nameEvoltra
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNclofarabine
    D.3.9.1CAS number 123318-82-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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
    Previously untreated intermediate and bad risk acute myelogenous leukemia (AML) or high risk myelodysplasia (MDS)
    E.1.1.1Medical condition in easily understood language
    Previously untreated intermediate and bad risk acute myelogenous leukemia (AML) or high risk myelodysplasia (MDS)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10028532
    E.1.2Term Myelodysplasia
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main of objective of the phase I part is to determine the optimum dose of Clofarabine (1-hour i.v. or push injection over 10 minutes) in combination with cytosine arabinoside and idarubicine to be recommended for the phase II trial.

    The main objective of the randomized phase II part of the trial is to explore the antitumor activity of the above mentioned treatment combination using the recommended dose of Clofarabine (1-hour i.v. or push injection over 10 minutes) as defined in the phase I.
    E.2.2Secondary objectives of the trial
    The secondary objective of the Phase I part is to determine activity expressed as CR/CRi rate following the induction (one or two cycles) and consolidation therapy, hematopoietic recovery (platelets and neutrophils) after induction and consolidation courses.
    The secondary objectives of the Phase II part are: Safety/tolerability, activity expressed as CR/CRi rate following consolidation course, hematopoietic recovery (platelets and neutrophils) after induction and consolidation courses feasibility of blood CD34 harvesting after consolidation treatment. DFS and survival from CR/CRi, and overall survival will be evaluated as well.
    The aim of the Phase II Part is also to investigate whether interaction between Clofarabine and cytosine arabinoside with respect to intracellular Ara-CTP and Clofarabine-TP levels takes place and whether a difference can be detected between the schedules with one-hour infusions or the push injections of Clofarabine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age 18 – 60 years (including 60)
    • AML according to the new WHO criteria i.e. percentage bone marrow (BM) blasts ≥ 20%, or MDS with ≥ 10% blast cells in the BM
    • All AML FAB subtypes except M3
    • All cytogenetic groups except:
    - those with t(15;17)
    - those with t(8;21) or inv(16), and a WBC count at diagnosis of < 100 x109/l
    • Primary and secondary AML (including AML after MDS)
    • Previously untreated, except for ≤ 14 days of hydroxyurea
    • WHO PS grade 0 – 2
    • Adequate renal and hepatic function tests as indicated by the following laboratory values:
    - serum creatinine ≤ 1.0 mg/dl(≤ 88.7micromol/L); if serum creatinine > 1.0 mg/dl (> 88.7micromol/L) then the glomerular filtration rate (GFR) must be > 60 ml/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation where the predicted GFR (ml/min/1.73 m2 ) = 186x(serum creatinine in mg/dl)-1.154 x (age in years)-0.203 x (0.742 if patient is female) x (1.212 if patient is black).
    NOTE: if serum creatinine is measured in micromol/L recalculate it in mg/dl according to the equation: 1 mg/dl=88.7micromol/L and used above mentioned formula
    - Aspartate Transaminase(AST)/Alanine transaminase(ALT) ≤ 2.5 x ULN and alkaline phosphatase ≤ 2.5 x ULN .
    • Potential fertile patients agree to use an effective barrier method of birth control during study treatment and for at least 3 months after end of study treatment.
    • Before patient registration/randomization, written informed consent must be given according to ICH/EU GCP, and national/local regulations
    • Patient can only be registered once in this Phase I/ Phase II trial
    E.4Principal exclusion criteria
    • Blast crisis of chronic myeloid leukemia or AML supervening a myeloproliferative disorder
    • Central nervous system leukemia
    • Concomitant malignant disease
    • Active uncontrolled infection
    • Concomitant severe uncontrolled cardiovascular disease i.e. symptomatic congestive heart failure or symptomatic ischemic heart disease (NYHA grade III-IV).
    • Any psychological, familial, sociological, and 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
    • Known HIV positivity
    • Pregnancy (in case of doubt a pregnancy test is required) and breast feeding women
    E.5 End points
    E.5.1Primary end point(s)
    • Phase I: determine the safety and tolerance of Clofarabine in combination with standard AML treatment during induction in order to determine the recommended dose (RD) for administration in phase II study.
    • Phase II: determine the activity expressed as CR/CRi rate following the induction course (one or two cycles).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The final analysis will take place at approximately end of recruitment + 1 year.
    E.5.2Secondary end point(s)
    • Phase I: determine activity expressed as CR/CRi rate following the induction (one or two cycles) and consolidation therapy, hematopoietic recovery (platelets and neutrophils) after induction and consolidation courses.
    • Phase II: Safety/tolerability, activity expressed as CR/CRi rate following consolidation course, hematopoietic recovery (platelets and neutrophils) after induction and consolidation courses feasibility of blood CD34 harvesting after consolidation treatment. DFS and survival from CR/CRi, and overall survival will be evaluated as well.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints will be analyzed at the same time as the primary endpoint analysis.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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
    Determination of optimum dose of Clofarabine in combination of AraC
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    Clofarabine administrated differently (compare 2 schemes of administration: 1h infusion vs iv push)
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Croatia
    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
    End of study occurs when all of the following criteria have been satisfied:
    1. Thirty days after all patients have stopped protocol treatment (induction/consolidation)
    2. The trial is mature for the analysis of the primary endpoint as defined in the protocol
    3. The database has been fully cleaned and frozen for this analysis
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years6
    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: 60
    F.1.3Elderly (>=65 years) No
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 52
    F.4.2.2In the whole clinical trial 60
    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)
    At the end of the the participation, according to their disease status , patients willl either be followed or treated according to standard of care applied at the treating institution.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-01-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-07-24
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