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    Summary
    EudraCT Number:2006-006130-17
    Sponsor's Protocol Code Number:Nordic Lymphoma Group
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-01-04
    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 ConcernedFinland - Fimea
    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 T-cell lymphomas
    A.3.2Name or abbreviated title of the trial where available
    ACT-1 ( Alemtuzumab and CHOP in T- cell lymphoma)
    A.4.1Sponsor's protocol code numberNordic Lymphoma Group
    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 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 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 Yes
    D.2.1.1.1Trade name Mab Campath
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    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
    Patients 18 - 65 years old with newly diagnosed non-cutanous, non leukemic Peripheral T- cell lymphoma, except alk-protein positive anaplastic large cell lymphoma.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10042971
    E.1.2Term T-cell lymphoma
    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 the effect of the addition af Mab Campath s.c. to 2 Weekly CHOP 14 ( Chemotherapy) in terms of event free survival (EVS).
    E.2.2Secondary objectives of the trial
    ¨ To assess the effect of the addition of alemtuzumab s.c. to 6 courses of 2-weekly CHOP14 in term of overall survival (OS), progression-free survival (PFS) and overall response rates (ORR, i.e. CR/CRu/PR). Assessment of ORR means evaluating eligibility to autologous stem cell transplantation.
    ¨ To evaluate the safety of the addition of alemtuzumab s.c. combined with 2-weekly CHOP with respect to the incidence of severe opportunistic infections and infections due to neutropenia as well as the adherence to protocol as defined in
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    9.1.1 Inclusion criteria
    ¨ Previously untreated patients with newly diagnosed peripheral T-cell lymphoma of stage I bulk (≥ 7.5 cm) and stages II to IV.
    ¨ Patients with a confirmed histologic diagnosis of peripheral T-cell NHL according to the WHO classification (Appendix C):
    ü Peripheral T-cell lymphoma, unspecified (PTCL NOS)
    ü Angioimmunoblastic T-cell lymphoma
    ü Enteropathy-type T cell lyphoma
    ü Primary systemic, alk-negative anaplastic large cell lymphoma (T- or null phenotype)
    ü Subcutaneous panniculitis-like T-NHL
    ü Hepatosplenic gd T-cell lymphoma
    ü Extranodal NK/T cell lymphoma, nasal type
    ¨ Age 18-65 years at time or randomization
    ¨ Life expectancy of 3 months or longer
    ¨ WHO performance status (PS) 0, 1 or 2 at the time of randomization (see appendix D). However, PS 3 will be acceptable if lymphoma-related.
    ¨ Measurable disease
    ¨ Written informed consent
    E.4Principal exclusion criteria
    ¨ Patients with NK/T-NHL of the following type:
    ü Precursor T cell lymphoblastic lymphoma/leukemia
    ü All mature T cell leukemias (T-PLL, ATLL, NK cell leukemia, T-LGL)
    ü Alk-positive anaplastic large cell lymphoma
    ü Blastic NK cell lymphoma
    ¨ Known hypersensitivity to murine or chimeric antibodies or proteins
    ¨ Severe cardiac dysfunction (NYHA classification II-IV, Appendix H) or LVEF < 45 %
    ¨ Significant renal dysfunction (serum creatinin > 2 times upper level), unless related to NHL
    ¨ Significant hepatic dysfunction (total bilirubin ³ 30 mmol/l or transaminases ³ 2.5 times normal level), unless related to NHL
    ¨ Suspected or documented Central Nervous System involvement by NHL
    ¨ Patients known to be HIV-positive
    ¨ Patients with active, uncontrolled infections, especially known seropositivity for HCV or HbsAg
    ¨ Patients with uncontrolled asthma or allergy, requiring steroid treatment
    ¨ Prior treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except local radiotherapy in case of extranodal NK/T cell lymphoma, nasal type
    ¨ History of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma
    ¨ Unwillingness or inability to comply with the protocol
    ¨ Simultaneous participation in any other study protocol
    E.5 End points
    E.5.1Primary end point(s)
    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
    · Institution of any additional unplanned anti-tumor treatment
    · Relapse after achievement of CR/CRu
    · 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.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 Yes
    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 No
    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 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.8.4.1Number 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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    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) 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 290
    F.4.2.2In the whole clinical trial 308
    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 Decision2008-03-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-05
    P. End of Trial
    P.End of Trial StatusCompleted
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