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    Summary
    EudraCT Number:2014-003171-39
    Sponsor's Protocol Code Number:T-Control
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-10-17
    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 ConcernedGermany - PEI
    A.2EudraCT number2014-003171-39
    A.3Full title of the trial
    Transfer of Streptamer-selected multi-antigen specific T cells to prevent infections and relapse and to reduce the risk of Graft-versus-Host Disease after allogeneic stem cell transplantation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Donation of enriched donor T-cells after stem cell transplantation, which are specificly directed against multiple target structures and which confer protection against viral infections and anti-leukemic activity against leukemia cells.
    Verabreichung von vorbehandelten Spenderabwehrzellen nach Stammzelltransplantation, die spezifisch gegen zahlreiche Zielstrukturen gerichtet sind und einen Schutz vor viralen Infektionen und einen Effekt gegen vorhandene Leukämiezellen aufrechterhalten können.
    A.3.2Name or abbreviated title of the trial where available
    Multi-antigen specific T Cells after allo-SCT
    A.4.1Sponsor's protocol code numberT-Control
    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 Hospital Wuerzburg
    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 supportEU
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Wuerzburg - Department of Medicine II
    B.5.2Functional name of contact pointHematology/Oncology
    B.5.3 Address:
    B.5.3.1Street AddressOberduerrbacherstr. 6
    B.5.3.2Town/ cityWuerzburg
    B.5.3.3Post code97080
    B.5.3.4CountryGermany
    B.5.4Telephone number004909312 01 4 00 01
    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 nameStreptamer-selected multi-antigen specific T cells
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    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) 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) 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 Yes
    D.3.11.13.1Other medicinal product typedirected donation of blood
    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 hematological malignancies after T cell depleted allo-SCT
    E.1.1.1Medical condition in easily understood language
    patient who are planned to undergo a T cell depleted allgeneic stem cell transplantation
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10000845
    E.1.2Term Acute lymphoblastic leukemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10000846
    E.1.2Term Acute lymphocytic leukaemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10029547
    E.1.2Term Non-Hodgkin's lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10028576
    E.1.2Term Myeloproliferative disorder
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10000886
    E.1.2Term Acute myeloid leukemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10025311
    E.1.2Term Lymphoma (non-Hodgkin's)
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10035226
    E.1.2Term Plasma cell myeloma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10000880
    E.1.2Term Acute myeloid leukaemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10028534
    E.1.2Term Myelodysplastic syndrome NOS
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10028533
    E.1.2Term Myelodysplastic syndrome
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10013238
    E.1.2Term Disorder myeloproliferative
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 feasibility and safety of the administration of donor derived multiantigen-specific T cells early after T cell depleted allo-SCT
    E.2.2Secondary objectives of the trial
    To determine the appearance or expansion of antigen specific donor derived T cells during eight weeks after the infusion of donor derived multiantigen-specific T cells.

    To evaluate whether the appearance or expansion of antigen specific donor derived T cells coincides with the clearance or prevention of circulating viruses (EBV, CMV, Adenovirus) or with an improvement in bone marrow chimerism or with a control in disease burden (malignant cells in blood or bone marrow or tumor size in case of malignant lymphoma)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female patients with planned T-cell depleted allo-SCT aged >= 18 with AML in first CR
    Male or female patients with planned T-cell depleted allo-SCT aged >60 years or pa-tients 18-60 years with comorbidity score (Sorror) >3 with one of these diagnoses:
    - Acute Lymphoblastic Leukemia in CR after prephase and first induction and consolidation therapy and WBC < 30 x 109/l in B-ALL or < 100 x 109/l in T-ALL at initial diagnosis. ALL with t(9;22), t(4;11), complex karyotype or 11q23 abnormalities will be excluded.
    - Acute Myeloid Leukemia in CR or blast free aplasia
    - Multiple myeloma at least in stable PR (no treatment foreseen in first 6 months after allo-SCT)
    - Non high grade B-NHL (B-CLL, Mantle cell lymphoma, Follicular Lymphoma, MALT, LPL) at least in stable PR (no treatment foreseen in first 6 months after allo-SCT)
    - Myeloprolypherative disorder at least in stable PR (no treatment foreseen in first 6 months after allo-SCT), excluding CML blastic phase
    - Myelodysplastic syndrome at least in stable PR (no treatment foreseen in first 6 months after allo-SCT)
    HLA type A*0201.
    Written informed consent of the patient
    Availability of a stem cell donor who meets the following inclusion criteria:
    - HLA type A*0201
    - CMV and/ or EBV seropositivity
    - Negative HIV testing (negartivity for viral infections such as hepatitis B or others are are not required, as long as a transplant indication is given)
    - Written informed consent of donor

    Inclusion criteria after allo-SCT: Stable engraftment of the allogeneic graft (platelets >20 *109/L, granulocytes > 0.5 *109/L)
    E.4Principal exclusion criteria
    Exclusion Criteria before allo-SCT:
    Disease specific treatment foreseen in the first 6 months after SCT
    Pregnant or lactating women.
    Severe psychological disturbances.
    Life expectation < 12 weeks.
    End stage irreversible multi-system organ failure
    Forseen participation in another clinical trial during or within 4 weeks before study en-try

    Exclusion Criteria after allo-SCT:
    Disease specific treatment foreseen in the first 6 months after SCT
    Pregnant or lactating women.
    Severe psychological disturbances.
    Histologically proven acute GVHD > grade I for which immune suppressive treatment is given
    Progressive disease for which therapy is needed
    Use of > 20 mg prednisone a day
    Life expectation < 12 weeks.
    End stage irreversible multi-system organ failure
    Participation in another clinical trial during or within 4 weeks before study entry

    Exclusion criteria at time of infusion of multiantigen-specific T cells:
    Acute GVHD (preferentially histologically proven) GVHD > grade I for which immune
    suppressive treatment is given
    Progressive disease for which therapy is needed
    Use of > 20 mg prednisone a day
    Life expectation < 12 weeks.
    End stage irreversible multi-system organ failure
    Uncontrolled bacterial or fungal infection.
    Evidence of rejection.
    E.5 End points
    E.5.1Primary end point(s)
    Toxicity: Cumulative incidence of acute GVHD overall grade 3 or higher in the three months after infusion of multi antigen-specific T cells.

    Feasibility: The proportion of donors who are asked between 4 and 6 weeks after the allo-SCT to donate lymphocytes and in whom the harvesting of those cells succeeds.
    The proportion of procedures to isolate the multiantigen-specific donor T cells which succeeds.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Toxicity of the infusion will be evaluated by the cumulative incidence of acute GVHD > overall grade II or death during three months after the infusion of the T cell product after LSLV

    As for feasibility, if out of the first fifteen donors who gave informed consent before allo-SCT and were asked for lymphocytes between 6 and 8 weeks, the collection of donor lymphocytes succeeds in < 6 patients, the strategy in which donor lymphocytes are collected between 6 and 8 weeks after allo-SCT is considered to be not feasible. If out of the first fifteen procedures to isolate multiantigen-specific T cells from donor lymphocytes, less than 6 result in an appropriate T cell product which can be given to the patient, the procedure is considered to be not feasible as well.
    E.5.2Secondary end point(s)
    Efficacy: The appearance or doubling of antigenic specific donor-derived T cells in the circulation within eight weeks after the infusion of multiantigen-specific T cells.

    Chimerism in bone marrow and peripheral lymphocytes

    Loads of circulating viruses (CMV, EBV, Adenovirus)

    Disease activity: malignant cells in bone marrow or blood, size of lymphoma

    Death
    E.5.2.1Timepoint(s) of evaluation of this end point
    WIll be analyzed at the end of the trial after LSLV
    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 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) 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 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) 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 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 subject last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state30
    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)
    All patients who underwent an allo-SCT are followed up life-long.
    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 Decision2016-03-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-04
    P. End of Trial
    P.End of Trial StatusOngoing
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