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    EudraCT Number:2012-002418-38
    Sponsor's Protocol Code Number:LUMC2012-01
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-06-15
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-002418-38
    A.3Full title of the trial
    Prophylactic infusion of CD4 positive donor lymphocytes early after T-cell depleted allogeneic stem cell transplantation in patients with an unrelated donor
    Profylactische infusie van CD4 positieve donor lymfocyten vroeg na een T-cel gedepleteerde allogene stamceltransplantatie bij patienten met een onverwante donor
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prophylactic infusion of CD4 positive donor lymphocytes early after T-cell depleted stem cell transplantation in patients with an unrelated donor
    Profylactisch infusie van CD4 positieve donor lymfocyten vroeg na een T-cel gedepleteerde stamceltransplantatie bij patienten met een onverwante donor
    A.3.2Name or abbreviated title of the trial where available
    CD4+ donor lymphocytes
    CD4+ donor lymfocyten
    A.4.1Sponsor's protocol code numberLUMC2012-01
    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 SponsorLeiden University Medical Center
    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 supportLeiden University Medical Center
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeiden University Medical Center
    B.5.2Functional name of contact pointClinical Research Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressP.O. Box 9600
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2300 RC
    B.5.4Telephone number31715262267
    B.5.5Fax number31715266755
    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 nameCD4 positive cells
    D.3.2Product code CD4+ cells
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCD4+ lymphocytes
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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) Yes
    D. cell therapy medicinal product Yes
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    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 with AML, MDS, ALL, CML in accelerated phase or blastic transformation, CLL, MM or aggressive lymphoma, who underwent a (non) myeloablative allo-SCT with an unrelated donor.
    Patienten met AML, MDS, ALL, CML in geaccelereerde fase of blastische transformatie, CLL, MM of agressief lymfoom, die een (non) myeloablatieve allo-SCT met een onverwante donor hebben ondergaan.
    E.1.1.1Medical condition in easily understood language
    Hematological malignant diseases
    hematologische kwaadaardige aandoeningen
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10007838
    E.1.2Term CD4 lymphocytes
    E.1.2System Organ Class 10022891 - Investigations
    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 whether CD4+ lymphocytes infusion given three months after T-cell depleted allogeneic stem cell transplantation (allo-SCT) improves immunological recovery (by increasing the number of circulating naïve CD4+ lymphocytes)
    - Evalueren of CD4 lymfocyteninfusie, gegeven op drie maanden na T-cel gedepleteerde allogene stamceltransplantatie, een verbeterde immuunreconstitutie geeft
    E.2.2Secondary objectives of the trial
    • To evaluate whether CD4+ lymphocytes infusion given three months after T-cell depleted allogeneic stem cell transplantation (allo-SCT) increases donor chimerism in B and T lymphocyte compartment (lineage specific chimerism).
    • To evaluate the effects of CD4+ lymphocytes infusion on the incidence of transplantation related complications during the first year after the transplantation. Transplantation related complications are defined as:
    o CMV disease or CMV reactivation needing systemic treatment
    o EBV reactivation needing systemic treatment
    o VZV infection
    o Other infections for which hospitalization is needed
    o GVHD needing systemic treatment
    o Auto-immune disorders needing systemic treatment.Please enter information in English and add any other language that is applicable
    - evalueren of CD4 lymfocyten infusie, gegeven op 3 maanden na allogene stamceltransplantatie, een verhoging van donor chimerisme in B en T lymfocyten geeft
    - Evalueren wat de effecten van CD4 lymfocyten infusie op de incidentie van transplantatie gerelateerde complicaties gedurende de het eerste jaar na de transplantatie zijn.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age > 18 years
    • Patients with AML, myelodysplasia , ALL, CML in accelerated phase or blastic transformation, CLL, MM or (non) Hodgkin lymphoma, who are definitely planned to undergo an allo-SCT with an unrelated donor who is matched for HLA-A, B, C, DR and DQ.
    • Life expectation of > 3 months
    • WHO performance status of 0, 1 or 2
    • Written informed consent according to the rules and regulations of the Leiden University Medical Center.
    - > 18 jaar
    - Patienten met AML, MDS, ALL, CML in geaccelereerde fase of blastische transformatie, CLL, MM of (non) Hodgkin lymfoom, die een allo-SCT zullen ondergaan met een 10/10 gematchte onverwante donor die gematched is voor HLA-A, B, C, DR en DQ.
    - levensverwachting van > 3 maanden
    - WHO performance status van 0, 1 of 2
    - Schriftelijk informed consent
    E.4Principal exclusion criteria
    • Use of systemic immunosuppressive treatment (due to GVHD)
    • Acute GVHD of the skin > grade 2 or progressive acute GVHD
    • Progressive disease needing cytoreductive treatment
    • Any concomitant disease preventing the safe administration of donor lymphocytes
    • Severe psychological disturbances
    • Severely limited life expectation due to diseases other than the malignancy
    • Very high risk disease preceding allo-SCT for which already unselected DLI is planned to be given 3 months after allo-SCT.
    - Gebruik van systemische immunosuppressieve behandeling
    - Acute GVHD van de huid; >graad 2 of progressieve acute GVHD
    - progressieve ziekte waarvoor cytoreductieve behandeling nodig is
    - een bijkomende ziekte die een veilige toediening van donor lymfocyten in de weg staat
    - ernstige psychologische afwijking
    - Zeer hoog risicp ziekte na de allo-SCT waarvoor reeds een ongeselecteerde DLI gepland staat op 3 maanden na allo-SCT
    E.5 End points
    E.5.1Primary end point(s)
    • The number of circulating naïve CD4+ lymphocytes 4.5 months after allo-SCT.
    - het aantal circulerende naieve CD4 lymfocyten, 4,5 maanden na allo-sct
    E.5.1.1Timepoint(s) of evaluation of this end point
    4.5 months after allo-SCT
    4.5 maand na allo-SCT
    E.5.2Secondary end point(s)
    - Lymphocyte chimerism status
    - Transplantation related complications between 3 and 12 months after the transplantation (CMV disease or CMV reactivation needing systemic treatment, EBV reactivation needing systemic treatment, VZV infection, other infections for which hospitalization, GVHD needing systemic treatment, auto-immune disorders needing systemic treatment).
    - lymfocyten chimerisme status
    - transplantatiegerelateerde complicaties tussen 3 en 12 maanden na transplantatie
    E.5.2.1Timepoint(s) of evaluation of this end point
    - 14, 20 and 26 weeks after allo-SCT
    - 9, 12, 15, 18, 21, 24, 30, 36 months after allo-SCT
    - 14, 20 en 26 weken na allo-SCT
    - 9, 12, 15, 18, 21, 24, 30, 36 maanden na allo-SCT
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    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. 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 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. description
    ongeselecteerde donor lymfocyten infusie
    Unselected Donor lymphocyte infusion
    E.8.2.4Number of treatment arms in the trial2
    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 No
    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
    last visit of last subject in the trial
    laatste follow-up bezoek van laatste patient in de studie
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state60
    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)
    regular care according to standard protocol of care after allogeneic transplantation
    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 Decision2012-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-21
    P. End of Trial
    P.End of Trial StatusOngoing
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