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    Summary
    EudraCT Number:2005-003026-26
    Sponsor's Protocol Code Number:ARL - GT 2005
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-03-14
    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 ConcernedGermany - PEI
    A.2EudraCT number2005-003026-26
    A.3Full title of the trial
    High-dose chemotherapy with transplantation of gene-modified haematopoietic stem cells for HIV-positive patients with malignant diseases indicating an HSCT
    A.4.1Sponsor's protocol code numberARL - GT 2005
    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 SponsorUniversity Medical Center Hamburg-Eppendorf
    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 No
    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 namePBSC-M87o
    D.3.2Product code PBSC-M87o
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous 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 Yes
    D.3.11.3.2Gene therapy medical product Yes
    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 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 Yes
    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
    HIV-positive patients with any malignant disease of the haematopoietic system indicating haematopoietic stem cell transplantation (autologous or allogeneic)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10061624
    E.1.2Term AIDS related complication
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To test the safety and potential toxicity of peripheral blood autologous and allogeneic gene-modified CD34+ hematopoietic progenitor cells given as a rescue for high-dose chemotherapy of malignant diseases indicating HSCT


    E.2.2Secondary objectives of the trial
    To reconstitute the immune system of HIV-positive patients with cells protected from HIV infection by an antiviral gene thereby reducing viral load and potentially regenerating immune competence and to achieve continuous complete remission (CCR) in HIV-positive requiring HSCT
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Male and female patients of any ethnic group aged between 18 and 65 years
    •HIV-positive patients with malignant diseases of the blood (NHL, Hodgin disease,
    plasmocytoma, acute and chronic leukaemia) indicating an HSCT:

    - M.Hodgkin: autologous SCT for relapsed patient, allogeneic SCT for relapse
    after autologous SCT or primary refractory disease or insufficient autologous
    stem cell collection
    - High grade NHL: autologous SCT for relapsed patient, allogeneic SCT for
    relapse after autologous SCT or primary refractory disease or insufficient
    autologous stem cell collection
    - Low grade NHL: autologous SCT for relapse after first or second line
    treatment, allogeneic SCT for relapse after autologous SCT
    - Multiple Myeloma: autologous SCT for chemosensitiv or chemorefractory
    diseases, allogeneic SCT for relapse after autologous SCT
    - AML: allogeneic SCT for 1. CR with high risk cytogenetic, refractory disease or
    remissionstatus > 1. CR
    - ALL: allogeneic SCT for high risk or very high risk disease , non complete or
    > 1.CR
    - CML: allogeneic SCT for patient resistant to tyrosine kinase inhibitor treatment

    •Patients must receive HAART
    E.4Principal exclusion criteria
    •Any of the following conditions: congestive heart failure (NYHA > II), documented EBV, HBV or HCV infection (only for allogeneic PBSCT), creatinine clearance < 60 ml/min, left ventricular ejection fraction < 40%, bilirubin > 2 mg/dl
    •Severe opportunistic infection
    •More than 10% of bone marrow involved with lymphoma
    •Between 2 and 5 x 106 autologous CD34+ cells /kg body weight obtained after leukapheresis and CD34 enrichment
    •Women of child-bearing potential not under adequate contraceptive protection
    •Women who are pregnant or breast feeding
    •Known history of drug-, medication- or alcohol abuse within the last 12 months preceding the study
    •Participation in another study with an investigational drug within less than one month prior to this study
    •Simultaneous participation in a study with an investigational drug
    •Presence of any disease likely to require procedures altering the schedule of this study
    •Patients who are unable or unwilling to meet the requirements of the protocol
    •Patients with a history of seizures, central nervous system disorders or psychiatric disability thought to be clinically significant in the opinion of the investigator
    •Patients with limited mental capacity to the extent that he/she cannot provide informed consent or information regarding adverse events of the study medication
    •Patients with any clinically meaningful renal, hepatic, respiratory or cardiovascular disease
    •Patients who will not accept transfusions of blood products
    E.5 End points
    E.5.1Primary end point(s)
    1)Efficacy of elimination of malignant cells and achievement of complete or partial remission
    2)Engraftment of stem cells and repopulation of the hematopoietic system
    3)Level of virus replication as measured by HIV RNA in plasma
    4)Lymphocyte differentiation (CD3/CD4/CD8) analysis as a parameter for immune competence and possible regeneration of the immune system after the trial treatment
    5) Toxicity
    6) Quality of life
    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 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) Yes
    E.7.1.1First administration to humans Yes
    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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 No
    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
    Trial duration is 24 months for each patient with detailed analysis of the patient data
    (screening, baseline, day-7, day 0, day 7, after week2, 3, 4, 6 and month 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, 24). The long term follow-up will be biannual for 5 years
    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 months2
    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.1.3Elderly (>=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 state10
    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 Decision2006-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-09-15
    P. End of Trial
    P.End of Trial StatusCompleted
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