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    The EU Clinical Trials Register currently displays   36095   clinical trials with a EudraCT protocol, of which   5934   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2006-006130-17
    Sponsor's Protocol Code Number:ACT-1
    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:2009-02-25
    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 number2006-006130-17
    A.3Full title of the trial
    ACT-1 (younger patients)
    A randomized phase III study to evaluate the efficacy of chemoimmunotherapy with the monoclonal antibody Campath-1H (Alemtuzumab) given in combination with 2-weekly CHOP versus 2-weekly CHOP alone and consolidated by autologous stem cell transplant, in young patients with previously untreated systemic peripheral Tcell lymphomas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ACT-1 (younger patients)
    Efficacy of chemoimmunotherapy with Alemtuzumab given in combination with CHOP followed by autologous stem cell transplant, in young patients with previously untreated systemic peripheral Tcell lymphomas.
    A.3.2Name or abbreviated title of the trial where available
    ACT-1
    A.4.1Sponsor's protocol code numberACT-1
    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 SponsorNordic Lymphoma Group
    B.1.3.4CountryDenmark
    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 supportNordic Lymphoma Group
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNordic Lymphoma Group
    B.5.2Functional name of contact pointFrancesco D´Amore
    B.5.3 Address:
    B.5.3.1Street AddressAArhus University Hospital
    B.5.3.2Town/ cityAarhus
    B.5.3.3Post code80000
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4589497567
    B.5.5Fax number+4589497599
    B.5.6E-mailfrandamo@rm.dk
    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 MabCampath
    D.2.1.1.2Name of the Marketing Authorisation holderGenzyme Europe BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameMabCampath
    D.3.2Product code EU/1/01/193/002
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNALEMTUZUMAB
    D.3.9.1CAS number 216503-57-0
    D.3.9.3Other descriptive nameALEMTUZUMAB
    D.3.9.4EV Substance CodeSUB12459MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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) 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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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
    Newly diagnosed non-cutaneous peripheral T-cell lymphoma (PTCL),
    except alk-protein positive and negative anaplastic large cell lymphoma
    E.1.1.1Medical condition in easily understood language
    non-cutaneous peripheral T-cell lymphoma (PTCL)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level HLT
    E.1.2Classification code 10034622
    E.1.2Term Peripheral T-cell lymphomas NEC
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determination of the efficacy and safety of the monoclonal antibody
    MabCampath® (alemtuzumab) combined with two-weekly CHOP
    supported by G-CSF
    E.2.2Secondary objectives of the trial
    Efficacy: Overall Response Rate, Complete Remission and Partial
    Remission (ORR, CR, PR) after induction chemotherapy, ORR related to
    tumoral CD52 status, eligibility for ASCT after induction in the young
    population ( 60 years). Overall survival (OS). Progression-free Survival
    (PFS). Safety. Adherence to protocol.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Previously untreated patients with newly diagnosed peripheral T-cell lymphoma of stage I bulk ( 7.5 cm) and stages II to IV.

    2. Patients with a confirmed histologic diagnosis of peripheral T-cell NHL according to the WHO classification (Appendix C):
    Peripheral T-cell lymphoma, unspecified (PTCL NOS)
    Angioimmunoblastic T-cell lymphoma
    Enteropathy-type associated T-cell lymphoma
    Subcutaneous panniculitis-like T-NHL (gd T-cell lymphoma)
    Hepatosplenic gd T-cell lymphoma
    Extranodal NK/T cell lymphoma, nasal type

    3. Age 18-60 years at the time of randomization for young patients’
    cohort

    4. Life expectancy of 3 months or longer

    5. ECOG performance status 0, 1 or 2 at randomization (see appendix D). PS 3 acceptable if lymphoma-related.

    6.Measurable disease

    7. Written informed consent
    E.4Principal exclusion criteria
    1. Patients with NK/T-NHL of the following type:
    Precursor T cell lymphoblastic lymphoma/leukemia
    All mature T cell leukemias (T-PLL, ATLL, NK cell leukemia, T-LGL)
    Alk-positive and negative anaplastic large cell lymphoma
    Blastic NK cell lymphoma
    Cutaneous T-cell lymphoma, transformed or not
    HTLV1-positive adult T-cell leukemia

    2. Concurrent severe and/or uncontrolled medical disease (e.g. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months prior to the study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection), which could compromise participation in the study.

    3. Known hypersensitivity to murine or chimeric antibodies or proteins

    4. Severe cardiac dysfunction (NYHA classification II-IV) or LVEF < 45%

    5. Significant renal dysfunction (serum creatinin > 2x UNL), unless related to NHL

    6. Significant hepatic dysfunction (total bilirubin ³ 30 ╬╝mol/l or transaminases ³ 2.5 times normal level), unless related to NHL

    7. Impaired pulmonary functions; in this case, the patient is to be excluded if the resultant pulmonary function test shows FEV1<50% or a diffusion capacity <50% of the reference values

    8. Suspected or documented central nervous system involvement by
    NHL

    9. Patients known to be HIV-positive

    10. Patients with active, uncontrolled infections, especially known seropositivity for HCV or HbsAg

    11. Patients with uncontrolled asthma or allergy, requiring systemic
    steroid treatment

    12. Prior treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except local radiotherapy in case of extranodal NK/T cell lymphoma, nasal type

    13. History of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma

    14. Unwillingness or inability to comply with the protocol
    E.5 End points
    E.5.1Primary end point(s)
    Event-Free-Survival
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint is the Event-free Survival (EFS). The EFS is defined by the time between
    day of randomization until one of the following events occurs, whichever comes first:
    • Disease progression during therapy
    • Relapse after achievement of CR/CRu
    • Institution of any additional unplanned anti-tumor treatment
    • Death due to any cause
    Patients who have not experienced an event at the time of analysis will be censored at the most
    recent date of disease assessment.
    E.5.2Secondary end point(s)
    Efficacy: Overall Response Rate, Complete Remission and Partial
    Remission (ORR, CR, PR) after induction chemotherapy, ORR related to
    tumoral CD52 status, eligibility for ASCT after induction in the young
    population ( 60 years). Overall survival (OS). Progression-free Survival
    (PFS). Safety. Adherence to protocol.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Response will be formally evaluated in both arms after cycles 3 and 6 according to the criteria of
    response, or evaluated after last cycle if treatment stopped earlier.
    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) No
    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 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 Yes
    E.8.2.3.1Comparator description
    CHOP backbone in both arms
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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 No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    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: 16
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 290
    F.4.2.2In the whole clinical trial 308
    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)
    routine oncological surveillance, as outlined in chapters 3.1.4 and 3.1.5 of the protocol
    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 Decision2010-11-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-31
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