Treatment of Chemo-refractory Viral Infections After Allogeneic Stem Cell Transplantation With Multispecific T Cells Against CMV, EBV and AdV: A Phase III, Prospective, Multicentre Clinical Trial

Who is this study for? Patients with Infections
What treatments are being studied? Multivirus (CMV, EBV, AdV)-Specific T Cells
Status: Recruiting
Location: See all (33) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Haematopoietic stem cell transplantation (HSCT) can expose patients to a transient but marked immunosuppression, during which viral infections are an important cause of morbidity and mortality. Adoptive transfer of virus-specific T cells is an attractive approach to restore protective T-cell immunity in patients with refractory viral infections after allogeneic HSCT. The aim of this Phase III trial is to confirm efficacy of this treatment in children and adults.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2 months
Healthy Volunteers: f
View:

• Adult or paediatric patients (\> 2 months of age) after allogeneic stem cell transplantation (SCT) (no time restrictions apply) suffering from new or reactivated CMV or EBV or AdV infection refractory to standard antiviral treatment for two weeks (defined as no decrease or insignificant decrease of less than 1log in viral load over two weeks) as confirmed by quantitative blood PCR analysis.

• Original HSCT-donor available with an immune response at least to the virus causing the therapy-refractory (=underlying) infection.

• Written informed consent given (patient or legal representative) prior to any study-related procedures.

Locations
Other Locations
Belgium
Institut Jules Bordet (JBI)
RECRUITING
Brussels
UZ Brussel
RECRUITING
Brussels
Ghent Universal Hospital (UZG)
RECRUITING
Ghent
UZ Leuven
RECRUITING
Leuven
Université de Liège (ULG)
RECRUITING
Liège
France
Hôpital Jeanne de Flandre, CHU Lille
RECRUITING
Lille
Institut d'Hématologie et Oncologie Pédiatrique (IHOPe)
RECRUITING
Lyon
Centre Hospitalier Régional Universitaire de Nancy (CHRU)
RECRUITING
Nancy
Hôpital de la Pitie-Salpêtrière
RECRUITING
Paris
Hôpital Necker - Enfants Malades
RECRUITING
Paris
Hôpital Robert Debré
RECRUITING
Paris
Germany
Charité Berlin (Campus Virchow-Klinikum) - Klinik für Pädiatrie mit Schwerpunkt Onkologie und Hämatologie
RECRUITING
Berlin
Universitätsklinikum Dresden
RECRUITING
Dresden
Universitätsklinikum Düsseldorf - Klinik für Kinder-Onkologie, -Hämatologie und klinische Immunologie
RECRUITING
Düsseldorf
Universitätsklinikum Essen - Pädiatrische Hämatologie-Onkologie
RECRUITING
Essen
Universitätsklinikum Freiburg - Klinik für Pädiatrische Hämatologie und Onkologie
RECRUITING
Freiburg Im Breisgau
Medizinische Hochschule Hannover - Zentrum für Kinderheilkunde und Jugendmedizin
RECRUITING
Hanover
Universitäsklinikum Leipzig - Medizinische Klinik und Poliklinik I
RECRUITING
Leipzig
Klinikum rechts der Isar der Technischen Universität - Klinik und Poliklinik für Innere Medizin III
RECRUITING
München
LMU Klinikum - Medizinische Klinik und Poliklinik III
RECRUITING
München
Klinikum rechts der Isar der Technischen Universität - Kinderklinik Schwabing
RECRUITING
Munich
LMU Klinikum - Dr. v. Haunersches Kinderspital
RECRUITING
Munich
Universitätsklinikum Regensburg - Pädiatrische Hämatologie, Onkologie und Stammzelltransplantation
RECRUITING
Regensburg
Universitätsklinikum Tübingen, Center for Pediatric Clinical Studies (CPCS)
RECRUITING
Tübingen
Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik II & Zentrum Innere Medizin (ZIM)
RECRUITING
Würzburg
Universitätsklinikum Würzburg - Pädiatrische Hämatologie, Onkologie und Stammzelltransplantation
RECRUITING
Würzburg
Italy
Ospedale Pediatrico Bambino Gesù (OPBG)
RECRUITING
Rome
Ospedale Infantile Regina Margherita - Oncoematologie Pediatrica
RECRUITING
Turin
Netherlands
Leiden University Medical Centre (LUMC) - Department of Hematology
RECRUITING
Leiden
Spain
Vall d'Hebron Institute of Oncology (VHIO)
RECRUITING
Barcelona
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Virgen del Rocío
RECRUITING
Seville
Hospital Universitario Politécnico La Fe
RECRUITING
Valencia
Contact Information
Primary
Tobias Feuchtinger, Prof
kjk.trace-study@uniklinik-freiburg.de
0049 (0)761 270
Backup
Theresa Käuferle, Dr
kjk.trace-study@uniklinik-freiburg.de
0049 (0)761 270
Time Frame
Start Date: 2019-08-27
Estimated Completion Date: 2028-09
Participants
Target number of participants: 149
Treatments
Experimental: Multivirus (CMV, EBV, AdV)-specific T cells
Allogeneic CD4+ and CD8+ T lymphocytes ex vivo incubated with synthetic peptides of the viral antigens of Cytomegalovirus, Adenovirus and Epstein-Barr Virus~Max dose:~* HLA-matched (8/8) donors: 1.0 x 10e5 T cells/kg recipient BW~* HLA-mismatched donors: 2.5 x 10e4 T cells/kg recipient BW~Min. dose:~\- 10 T cells/kg recipient BW
Placebo_comparator: Sodium chloride
Suspension of multivirus-specific T cells in 20 mL of 0.9% NaCl + 0.5% HSA
Authors
Sabrina Kraus, Mareike Verbeek, Britta Maecker-Kolhoff, Johanna Tischer, Roland Meisel, Peter Lang, Tobias Feuchtinger, Johannes Schulte, Hermann Einsele, Peter van Balen, Yves Beguin
Related Therapeutic Areas
Bone Marrow Transplant
Cytomegalic Inclusion Disease
Sponsors
Collaborators: Leiden University Medical Center, LUMC, Leiden, The Netherlands, Ghent University Hospital, UZG, Ghent, Belgium, Central Hospital, Nancy, France, Vall d'Hebron Institute of Oncology, Miltenyi Biotec B.V. & Co. KG, Bergisch Gladbach, Germany, Ospedale Pediatrico Bambino Gesù, OPBG, Rome, Italy, Newcastle University, UNEW, Newcastle, UK, European Commission, Simbec-Orion Group Ltd, Merthyr Tydfil, UK
Leads: Tobias Feuchtinger

This content was sourced from clinicaltrials.gov

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