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    The EU Clinical Trials Register currently displays   35511   clinical trials with a EudraCT protocol, of which   5839   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2005-000173-21
    Sponsor's Protocol Code Number:(no code number allocated)
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-10-24
    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 ConcernedAustria - BASG
    A.2EudraCT number2005-000173-21
    A.3Full title of the trial
    A PHASE II CLINICAL STUDY TO DETERMINE THE EFFICACY AND SAFETY OF DEPOCYTE® (CYTARABINE LIPOSOME INJECTION) FOR THE TREATMENT OF CNS RELAPSE IN ADULT PATIENTS WITH ACUTE LYMPHOBLASTIC LEUKEMIA OR HIGH-GRADE LYMPHOMA
    A.3.2Name or abbreviated title of the trial where available
    DepoCyte® in ALL / NHL CNS relapse
    A.4.1Sponsor's protocol code number(no code number allocated)
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Number---
    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 SponsorDieter Hoelzer, MD,PhD
    B.1.3.4CountryGermany
    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 DepoCyte
    D.2.1.1.2Name of the Marketing Authorisation holderSkypharma PLC; 105 Picadilly; London; W1V 9FN; UK
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameDepoCyte
    D.3.2Product code ---
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntrathecal 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 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 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
    Acute lymphoblastic leukaemia
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Response rate after one application of DepoCyte®
    (The objective is to confirm efficacy and safety of DepoCyte® for treatment of CNS relapse in adult patients with acute lymphoblastic leukemia or very aggressive lymphoma)
    E.2.2Secondary objectives of the trial
    - Reponse rate at later time-points
    - Toxicity according to WHO
    - Death in induction and in CR
    - Time to neurological progression
    - The frequency of improvement in pre-existing meningeal-disease related neurological symptoms
    - Karnofsky Performance Status
    - Survival (all-cause and meningeal disease-specific)
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    - Patients with acute lymphoblastic leukemia or very aggressive Non-Hodgkin-
    Lymphoma (Burkitt/Burkitt-like) and CNS relapse.
    CNS involvement must be demonstrated by:
    * A positive ventricular or lumbar CSF cytology defined as CSF cell counts > 5/µl (19/3 cells), obtained within 10 days prior to inclusion OR
    * Characteristic signs and symptoms of neoplastic meningitis PLUSan MRI or CT scan indicating the presence of meningeal involvement.
    Patients with combined relapse in CNS and other locations may be included in case that systemic therapy with CNS active drugs (HDMTX; HDAC, Thiotepa) can be postponed for at least 2 weeks.
    - Karnofsky >= 60%
    - Age >= 18 years
    - Free of uncontrolled infection
    - Recovery from grade III/IV toxicities attributable to prior treatment with the
    exception of hematotoxicity
    - The patient must not be pregnant or breast feeding. If the patient is a female of
    child-bearing potential she must have a negative (urine or serum) pregnancy test
    and be using effective methods to prevent pregnancy.
    - No severe heart, lung, liver or kidney dysfunction
    - The patient or guardian must be competent to provide informed consent and must
    provide written informed consent prior to the initiation of study procedures.
    E.4Principal exclusion criteria
    - Failure (as defined by no clearance of the CSF) to > 1 dose of prior intrathecal MTX
    or cytarabine or triple (MTX, ARA-C, dexamethasone) therapy
    - History of previous severe neurotoxicity (grade III-IV) attributed to intrathecal
    therapy or systemic high-dose therapy with methotrexate or cytarabine (vincristine
    induced peripheral neuropathy is accepted)
    - Prior CNS relapse < 1 month before
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be
    · response rate after one application of DepoCyte®
    Further endpoints are:
    · Reponse rate at later time-points
    · Toxicity according to WHO
    · Death in induction and in CR
    · Time to neurological progression
    · The frequency of improvement in pre-existing meningeal-disease related
    neurological symptoms
    · Karnofsky Performance Status
    · Survival (all-cause and meningeal disease-specific
    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 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.8.5The 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 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 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 years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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 2005-10-24. 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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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 Decision2005-11-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-11-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-06-30
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