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    Summary
    EudraCT Number:2007-000821-23
    Sponsor's Protocol Code Number:DSHNHL2006-1B/ACT-2
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-09-10
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2007-000821-23
    A.3Full title of the trial
    A randomised Phase III trial to evaluate the efficacy of chemoimmunotherapy with the monoclonal antibody Campath-1H (Alemtuzumab) given in combination with 2-weekly CHOP (Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) versus 2-weekly CHOP alone in elderly patients with previously untreated systemic T- cell Lymphoma Short Title: A-CHOP-14 (elderly)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A-CHOP-14 (elderly)
    A.3.2Name or abbreviated title of the trial where available
    HOVON 91 T-NHL / ACT-2
    A.4.1Sponsor's protocol code numberDSHNHL2006-1B/ACT-2
    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 SponsorUniversity Medicine Goettingen
    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 supportBayer Pharma AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDep, Hematology, University Medicine Goettingen
    B.5.2Functional name of contact pointACT-2 Trial Office
    B.5.3 Address:
    B.5.3.1Street AddressRobert-Koch-Str. 40
    B.5.3.2Town/ cityGoettingen
    B.5.3.3Post code37075
    B.5.3.4CountryGermany
    B.5.4Telephone number+49551 39178546
    B.5.5Fax number+495513922180
    B.5.6E-mailestitz@med.uni-goettingen.de
    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 holderBayer Schering Pharma AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 namealemtuzumab
    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.3.11 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
    Primary therapy of patients with Alk-negative T-NHL in patients aged 61 - 80 years
    ICD classification codes : ICD-O 9702/3; 9717/3; 9716/3; 9708/3; 9705/3; 9714/3
    E.1.1.1Medical condition in easily understood language
    Alk-negative T-NHL in patients aged 61 - 80 years
    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 10025632
    E.1.2Term Malignant lymphoma
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10002464
    E.1.2Term Angiomimmunoblastic (AILD, LgX (Kiel Classification)
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Improvement of the efficacy of chemotherapy with CHOP-14 by the additional use of the CD52 monoclonal antibody alemtuzumab measured on the basis of Event-free Survival
    E.2.2Secondary objectives of the trial
    Comparison of +/- alemtuzumab addition concerning further endpoints of efficacy, short term and long term side effects, adherence to protocol and withdrawal from therapy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age: 61 - 80 years

    2. Risk group: All risk groups, including stage I with bulk (≥ 7.5 cm) and stages II to IV, exept stage I with no further IPI risk factor (LDH, ECOG, stage, E>1) beside the age over 60

    3. Histology: Diagnosis of aggressive non-Hodgkin's lymphoma, confirmed by an excisional biopsy of a lymph node or by a sufficiently extensive biopsy of an extranodal involvement if there is no lymph node involvement. It will be possible to treat all peripheral T-lineage lymphomas with the exception of ALK-positive anaplastic large cell lymphoma and primary cutaneous T-cell lymphomas (Mycosis fungoides, Sezary syndrome and primary cutaneous CD30-positive lymphoproliferations, and transformed primary cutaneous T-cell lymphomas). These lymphomas comprise:


    T cell -NHL:
    peripheral T-cell lymphoma PTCL-NOS
    Lennert's lymphoma
    T-zone lymphoma
    T-cell lymphoma of the AILD type
    anaplastic large cell lymphoma, ALK negative
    extranodal NK/T-cell lymphoma, nasal type
    intestinal T/NK-cell lymphoma ( enteropathy)
    hepatosplenic gamma-delta lymphoma
    subcutaneous panniculitis-like PTCL



    4. Performance status: Performance status ECOG 0 - 2 (Karnofsky index: 60 - 100%). The general status of each patient is to be assessed at time of randomisation and can thus take place after initiation of prephase treatment. A performance status of ECOG 3 will allow inclusion, if it is lymphoma related. The pretreatment status is to be documented in the staging CRF; the performance after the prephase treatment is also to be documented in the relevant CRF for the prephase treatment (see Appendix). A definition of the performance status is provided in the Appendix.

    5. Declaration of center participation

    6. written consent of the patient

    7. measurable disease
    E.4Principal exclusion criteria
    1. Stage I with IPI 0 and without bulk
    2. Already initiated lymphoma therapy (except for the prephase treatment specified for this study)
    3. Serious accompanying disorder or impaired organ function, in particular:
    - Cardiac: angina pectoris CCS >2, cardiac failure NYHA >2 and/or EF <45% or FS<25% in echocardiography/nuclear medicine examination
    - Pulmonary: abnormal blood gases; 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
    - Renal: creatinine >2 times the upper reference limit, unless related to NHL
    - Hepatic: bilirubin >2 times the upper reference limit, unless related to NHL
    - Uncontrollable diabetes mellitus (prephase treatment with prednisone!)
    4. Platelets <100 000/mm3, leukocytes <2500/mm3
    5. Bone marrow involvement >25%
    6. Primary leukemic manifestation of the lymphoma
    7. Known hypersensitivity to the medications to be used, especially murine or chimeric antibodies
    8. Known HIV-positivity
    9. Active hepatitis infection, active CMV infection, active systemic fungal infection, active infection with mycobacterium tuberculosis or atypical tuberculosis
    10. Suspicion that patient compliance will be poor
    11. Simultaneous participation in any other study protocol
    12. Prior chemo- or radiotherapy for malignancy
    13. Other concomitant malignant disease (history of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma)
    14. Non-conformity to eligibility criteria
    E.5 End points
    E.5.1Primary end point(s)
    event-free survival (EFS) at 3 years
    E.5.1.1Timepoint(s) of evaluation of this end point
    Interim analysis in 2012
    Final Analysis in 2016
    E.5.2Secondary end point(s)
    CR and OR rate, rate of primary progression, relapse rate, treatment-related deaths, overall survival, progression free survival, tumour control, disease-free survival, safety, protocol adherence, immune reconstitution after therapy
    E.5.2.1Timepoint(s) of evaluation of this end point
    Interim analysis in 2012
    Final Analysis in 2016
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    no antibody
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA52
    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 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 years8
    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 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.1.2.1Number of subjects for this age range: 33
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 83
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 116
    F.4.2.2In the whole clinical trial 116
    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 Decision2008-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-25
    P. End of Trial
    P.End of Trial StatusCompleted
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