Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2005-006163-31
    Sponsor's Protocol Code Number:Hx-CD20-406
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-10-11
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2005-006163-31
    A.3Full title of the trial
    A single-arm, international, multi-center trial of HuMax-CD20, a fully human monoclonal anti-CD20 antibody, in patients with B-cell Chronic Lymphocytic Leukemia who have failed fludarabine and alemtuzumab
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberHx-CD20-406
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Number2005-006163-31
    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 SponsorGENMAB
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorCommercial
    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.2.5The 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 nameHuMax-CD-20
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeHumax-CD-20
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 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
    B-cell Chronic Lymphocytic Leukemia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10008958
    E.1.2Term Chronic lymphocytic leukaemia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy and safety of HuMax-CD20 in patients with B-cell Chronic Lymphocytic Leukemia B-CLL who have failed fludarabine and alemtuzumab
    E.2.2Secondary objectives of the trial
    To determine the host immune response to HuMax-CD20 To determine the pharmacokinetic profile of HuMax-CD20
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    The trial population will be comprised of patients with a diagnosis of B-CLL who have failed both fludarabine and alemtuzumab and who have received an alkylating therapy such as cyclophosphamide or chlorambucil and who have active disease. Active B-CLL is defined and confirmed according to the NCIWG guidelines 1 and with an indication for treatment. Failing at least one fludarabine-containing treatment regimen is defined as 1. Refractory to one fludarabine -containing treatment regimen, defined as a. failure to achieve PR or CR to at least one fludarabine-containing treatment regimen; or, b. disease progression while on a fludarabine-containing treatment regimen; or, c. disease progression in responders within 6 months of the last dose of a fludarabine-containing treatment regimen 2. Intolerant to fludarabine, defined as a. Discontinuation of therapy due to side effects/toxicity whether or not response occurred; or b. Ineligible to treatment with fludarabine due to history of previous fludarabine-induced autoimmune hemolytic anemia or autoimmune thrombocytopenia Failing at least one alemtuzumab-containing treatment regimen is defined as 1. Refractory to one alemtuzumab-containing treatment regimen, defined as a. failure to achieve PR or CR to at least one alemtuzumab-containing treatment regimen; or, b. disease progression while on a alemtuzumab-containing treatment regimen; or, c. disease progression in responders within 6 months of the last dose of a alemtuzumab-containing treatment regimen 2. Intolerant to alemtuzumab, defined as a. Discontinuation of therapy due to side effects/toxicity whether or not response occurred; or, b. Ineligible to treatment with alemtuzumab due to concurrent medical conditions, such as i. previous pneumocystis carinii pneumonia PCP ii. history of other severe opportunistic infections iii. repeated grade 3 or 4 infections of other types A patient must have failed at least one fludarabine-containing treatment regimen and one alemtuzumab-containing treatment regimen, as defined above. Patients must have received at least one alkylating therapy. Patients may have received at most five previous treatment regimens for B-CLL. Patients must have an ECOG Performance Status of 0 or 1 and a life expectancy of at least 4 months. The patients should be 8805; 18 years of age and have given informed consent. A patient must have failed at least one fludarabine-containing treatment regimen and one alemtuzumab-containing treatment regimen, as defined above. Patients must have received at least one alkylating therapy. Patients may have received at most five previous treatment regimens for B-CLL. Patients must have an ECOG Performance Status of 0 or 1 and a life expectancy of at least 4 months. The patients should be 8805; 18 years of age and have given informed consent.
    E.4Principal exclusion criteria
    The most important exclusion criteria consist of more than two previous treatment regimens that included purine analogues e.g. fludarabine, cladribine, pentostatin , more than five previous treatment regimens for B-CLL, previous treatment with alemtuzumab within 6 weeks prior to Visit 1, autologous and allogeneic stem cell transplantation at any time, radioimmunotherapy at any time or anticancer therapy within 4 weeks prior to Visit 1 and known or suspected transformation of B-CLL.
    E.5 End points
    E.5.1Primary end point(s)
    Per le definizioni dei criteri secondari, vedere il paragrafo. paragrafo 4.4 del protocollo Criteri di efficacia 1. Durata della risposta 2. Sopravvivenza libera da progressione PFS 3. Periodo di tempo fino alla successive terapia per B-LLC 4. Sopravvivenza globale 5. Riduzione delle dimensioni del tumore 6. CD5 CD19 , CD5 CD20 nel sangue periferico, e espressioni di CD19, CD20, CD55 e CD59 su cellule CD45 CD5 7. Sintomi costituzionali 8. Risoluzione della linfoadenopatia 9. Risoluzione della organomegalia 10. Valore di prognosi dei parametri FISH, ZAP-70, CD38 , VH stato mutazionale, FC polimorfismi dei recettori, mutazione C1qA-276 11. Miglioramento dello stato di validita secondo la scala ECOG 12. Miglioramento del livello di emoglobina 13. Miglioramento della trombocitopenia 14. Miglioramento della neutropenia 15. Numero di trasfusioni di sangue 16. Numero di infezioni di grado 3 e 4 17. Numero di emolisi autoimmuni Criteri di sicurezza 18. Eventi avversi 19. Cellule CD5-CD19 e CD5-CD20 nel sangue periferico 20. Cellule CD45 CD3 e CD45 CD3 CD4 nel sangue periferico 21. Anticorpi umani anti-umani HAHA 22. Biochimica 23. Ematologia 24. Complemento Criteri farmacocinetici PK 25. AUC, Cl, Cmax, Cmin, Tmax, T , Vz
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 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 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 years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    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.1.3Elderly (>=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 2006-10-11. 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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 100
    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 Decision2006-07-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-05-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-06-06
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 26 00:18:57 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA