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    Summary
    EudraCT Number:2015-001522-41
    Sponsor's Protocol Code Number:PACT2014-001
    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:2015-07-03
    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 number2015-001522-41
    A.3Full title of the trial
    Prophylactic application of donor-derived central memory T lymphocytes (TCM) after allogeneic HSCT to prevent infectious complications
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Donation of donor T lymphocytes (TCM) after stem cell transplantation, which are specificly directed against multiple pathogenic organism or body tissue
    Verabreichung von Spender Gedächtnis-Zellen nach erfolgter Stammzelltransplantation, die im Spender gegen Krankheitserreger ausgerichtet wurden und gegen Infektionen und möglicherweise auch gegen die bösartige Grunderkrankung gerichtet sind.
    A.3.2Name or abbreviated title of the trial where available
    Prophylactic application of donor-derived TCM after allogeneic HSCT
    A.4.1Sponsor's protocol code numberPACT2014-001
    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 supportDeutsches Zentrum für Infektionsforschung
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Wuerzburg - Departement 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 number004993120144500
    B.5.6E-mailgrigoleit_g@ukw.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 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 nameTCM allogene humane central memory T cells, cryopreserved
    D.3.4Pharmaceutical form Solution for injection
    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 acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) after T cell depleted allo-SCT
    E.1.1.1Medical condition in easily understood language
    patients suffering from acute myeloid leukemia or myelodysplastic syndrome who are planned to undergo a T cell depleted allogeneic 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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10028555
    E.1.2Term 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 21.1
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the toxicity and feasibility of prophylactic administration of donor derived central memory T Cells after T cell depleted allo-SCT
    E.2.2Secondary objectives of the trial
    - the determination of appearance or expansion of antigen specific T cells from donor-derived TCM during 36 weeks (9 months) after the first infusion of study medication.
    - the evaluation of the incidence of viremia and clinical manifestations of virus related organ manifestations (CMV, EBV, Adenovirus, HSV, VZV)
    - Clinical signs of viral infections
    - Incidence of relapse
    - Incidence of bacterial and fungal infections
    - Evaluate the effect on mixed bone marrow and/or peripheral blood chimerism
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient
    • Male or female patients with HCT-CI score (Sorror) >= 3 AND/or Age 50 years or older
    • Primary or secondary AML M0, M1, M2, M4, M5, M6 and M7 in CR (<5% blasts in BM) irrespective of the cytogenetic or molecular risk profile or MDS up to RAEB-2 (maximal 20% blasts in bone marrow)
    • Planned alloHSCT with CD34+-purified stem cell grafts after conditioning with fludarabin-melphalan-thio-thepa-ATG
    • HLA-matched stem cell donor (9-10/10, maximal 1 allel- or antigen mismatch allowed) without aberrant CD45RA expression
    • Donor must have met requirements of EU Tissue and Cells Directive (2004/23/EC) as (see below)
    Additional patient inclusion criteria: Treatment phase patients at day 30 +/-5 after alloHSCT:
    • Stable engraftment of the allogeneic graft (granulocytes > 0.5*109/L)
    Donor
    • Healthy donor - having passed medical examination for stem cell donation
    • Donor must fulfill the requirements for allogeneic donor blood testing according to Richtlinie zur Herstellung und Anwendung von hämatopoetischen Stammzellzubereitungen
    • Donor informed consent for additional non-mobilized apheresis
    • Written informed consent of the patient
    E.4Principal exclusion criteria
    Patient
    • Disease specific treatment foreseen in the first 6 month after HSCT
    • Patients with AML M3
    • Pregnant or lactating women
    • Severe psychological disturbances
    • Positive serology for Human immunodeficiency virus (HIV), Syphilis, WNV
    • Participation in another interventional clinical trial during or within 4 weeks before study entry
    Additional patient exclusion criteria: Treatment phase patients at day 30 +/-5 after alloHSCT:
    • Disease specific treatment foreseen in the first 6 months after SCT
    • Acute GVHD > grade I for which immune suppressive treatment is given
    • Progressive disease for which therapy is needed
    • Use of > 0,5 mg/kg bw prednisone a day
    • Life expectation < 12 weeks
    • End stage irreversible multi-system organ failure

    Donor
    • Donor pregnant or lactating
    • Donors with aberrant CD45RA isoform expression
    • General exclusion criteria for stem cell donation
    E.5 End points
    E.5.1Primary end point(s)
    Toxicity: Cumulative incidence of acute GVHD overall grade 3 or higher within three months after infusion of the last dose of TCM

    Feasibility: The proportion of donors who consent to an additional apheresis procedure, and the proportion of patients that are not excluded before the transfer of the first dose of TCM on day 30 +/- 5
    E.5.1.1Timepoint(s) of evaluation of this end point
    Toxicity will be evaluted on an ongoing basis. In case of acute GVHD overall grade ≥ III in 2 out of the first 3 evaluable patients, or 3 out of the first 6 patients, or 4 out of the first 10 patients, the study will be closed temporarily for inclusions and the outcomes in all patients will be presented to the DSMB in order to decide whether potential beneficial effects of the treatment could overcome non-beneficial effects of GVHD.
    Efficacy will be evaluted after first fifteen procedures to isolate TCM has taken place. If out of the first fifteen procedures to isolate TCM from non-mobilized apheresis products less than 6 result in an appropriate TCM cell product which can be given to the patient, the procedure is considered to be not feasible and the study will be stopped.
    E.5.2Secondary end point(s)
    - To determine the appearance or expansion of antigen specific T cells from donor-derived TCM during 36 weeks (9 months) after the infusion of study medication.
    - To evaluate the incidence of viremia and clinical manifestations of virus related organ manifestations (CMV, EBV, Adenovirus, HSV, VZV)
    - Clinical signs of viral infections
    - Incidence of relapse
    - Incidence of bacterial and fungal infections
    - Evaluate the effect on mixed bone marrow and/or peripheral blood chimerism

    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary objectives will be analyzed at the end of the trial
    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 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 concerned6
    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 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
    Last subject last visit
    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 months7
    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) No
    F.1.2.1Number of subjects for this age range: 10
    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 state25
    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 Decision2016-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-08-23
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