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    Summary
    EudraCT Number:2008-005798-36
    Sponsor's Protocol Code Number:HOVON100ALL/EORTC06083
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-03-22
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2008-005798-36
    A.3Full title of the trial
    Clofarabine added to prephase and consolidation therapy in acute lymphoblastic leukemia in adults.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clofarabine added to prephase and consolidation therapy in acute lymphoblastic leukemia in adults.
    A.3.2Name or abbreviated title of the trial where available
    HOVON 100 ALL / EORTC 06083
    A.4.1Sponsor's protocol code numberHOVON100ALL/EORTC06083
    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 SponsorHOVON Foundation
    B.1.3.4CountryNetherlands
    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/sanofi
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHovon
    B.5.2Functional name of contact pointHDC
    B.5.3 Address:
    B.5.3.1Street AddressPO Box 2040
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3000 CA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31(0)107041560
    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 1 mg/ml concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderGenzyme Europe BV
    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 (ALL), EU/3/03/141 (AML)
    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.3.11 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 Yes
    D.3.11.13.1Other medicinal product typechemotherapeutic agent
    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
    Primary previously untreated B or T-lineage ALL (excluding ALL with mature B-cell phenotype, but including Philadelphia positive or BCR-ABL positive ALL) or previously untreated T-LBL
    E.1.1.1Medical condition in easily understood language
    acute lymphoblastic leukemia
    T-cell lymphoblastic lymphoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10000845
    E.1.2Term Acute lymphoblastic leukemia
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase II part
    - To determine the feasibility of adding i.v. clofarabine to standard prephase therapy (followed by induction chemotherapy)

    Phase III part
    - To improve EFS in adult ALL patients by the addition of i.v. clofarabine to the standard prephase and consolidation therapy
    E.2.2Secondary objectives of the trial
    - To improve the molecular response rate of adult ALL following RI by the addition of i.v. clofarabine to standard prephasepreophase and consolidation therapy
    - To improve DFS, and OS in adult ALL patients by the addition of i.v. clofarabine to the standard prephase and consolidation therapy
    - To document safety and toxicity of adding clofarabine to standard prephase and consolidation therapy in adult ALL
    -To assess and compare clinical outcome of patients with and without an HLA-identical sibling in a donor vs no-donor analysis
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients aged 18 to 70 years inclusive
    - Primary previously untreated B or T-lineage ALL (excluding ALL with mature B-cell
    phenotype, but including Philadelphia positive or BCR-ABL positive ALL) or previously untreated T-LBL (pretreatment with prednisolone for 7 days is allowed)
    - WHO performance status 0 – 2
    - Adequate renal and hepatic function tests as indicated by the following laboratory
    values:
    - Serum creatinine ≤1.0 mg/dl (≤ 88.7 micromol/L); if serum creatinine >1.0 mg/dl
    (>88.7 micromol/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) = 186 x (Serum Creatinine in
    mg/dl)-1.154 x (age in years)-0.023 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 = 88.7 micromol/L) and used above mentioned
    formula.
    - Serum bilirubin ≤ 1.5 × upper limit of normal (ULN)
    - Aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 2.5 × ULN
    - Alkaline phosphatase ≤ 2.5 × ULN
    - Negative pregnancy test at inclusion, if applicable
    - Written informed consent
    E.4Principal exclusion criteria
    - Mature surface Ig positive B-cell leukemia/lymphoma
    - Acute undifferentiated leukemia
    - Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive
    heart failure or symptomatic ischemic heart disease)
    - Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D)
    - Severe neurological or psychiatric disease
    - History of active malignancy during the past 5 years with the exception of basal
    carcinoma of the skin or stage 0 cervical carcinoma
    - Active, uncontrolled infection
    - Patient known to be HIV-positive
    - Patient is a lactating woman
    - Any psychological, familial, sociological and geographical condition potentially
    hampering compliance with the study protocol and follow-up schedule
    - Unwilling or not capable to use effective means of birth control
    E.5 End points
    E.5.1Primary end point(s)
    Phase II of the study: Feasibility (i.e. defined as less than 10% increase in DLT (e.g. from 20% to 30%) and 5% increase in TRM in arm B compared to arm A
    Phase III of the study: Event free survival (i.e. time from registration until no CR on protocol treatment, relapse or death in 1st CR, whichever comes first)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At entry: The investigations before start of treatment should be no older than 14 days prior to randomization unless otherwise noted in the following part
    During induction, consolidation, intensification, allo-SCT, interphase and maintenance therapy during follow up
    E.5.2Secondary end point(s)
    MRD level following induction chemotherapy
    - MRD level prior start of maintenance
    - Blood blast clearance (corticosteroid sensitivity)(day 8 of prephase)
    - Chemosensitivity (day 15 counted from start prephase therapy)
    - Hematological response
    - Disease free survival (hematologically; i.e. time from CR until relapse or death, whichever comes first)
    - Disease free survival (molecularly); i.e. time from molecular CR until molecular relapse or death (whichever comes first)
    - Overall survival, measured from the time of registration. Patients still alive or lost to follow up are censored at the date they were last known to be alive.
    - Adverse events
    - Relapse as from start of maintenance
    - Incidence of objectively diagnosed symptomatic thromboembolic events
    - Influence of ALL (treatment) on plasma coagulation markers
    E.5.2.1Timepoint(s) of evaluation of this end point
    At entry: The investigations before start of treatment should be no older than 14 days prior to randomization unless otherwise noted in the following part
    During induction, consolidation, intensification, allo-SCT, interphase and maintenance therapy during follow up
    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 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) Yes
    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
    addition of clofarabine
    E.8.2.4Number of treatment arms in the trial2
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    Belgium
    Croatia
    France
    Netherlands
    Portugal
    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
    provided in protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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: 326
    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 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 2010-03-22. Yes
    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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 325
    F.4.2.2In the whole clinical trial 340
    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)
    normal treatment
    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 Decision2010-04-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-06-30
    P. End of Trial
    P.End of Trial StatusOngoing
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