Spots Global Cancer Trial Database for Efficacy Study on the Strategy of HSV-Tk Engineering Donor Lymphocytes to Treat Patients With High Risk Acute Leukemia
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Trial Identification
Brief Title: Efficacy Study on the Strategy of HSV-Tk Engineering Donor Lymphocytes to Treat Patients With High Risk Acute Leukemia
Official Title: TK008: Randomized Phase III Trial of Haploidentical HCT With or Without an Add Back Strategy of HSV-Tk Donor Lymphocytes in Patients With High Risk Acute Leukemia
Study ID: NCT00914628
Conditions
Study Description
Brief Summary: The main objective of this randomized trial is to compare disease-free survival (DFS) in high risk leukemia patients who underwent haploidentical HCT followed by an add back strategy of HSV-Tk donor lymphocytes or standard haploidentical HCT
Detailed Description: Delayed immune-reconstitution remains one of the main limitation of haploidentical stem cell transplantation. The risk of severe infections remains high for several months and CD3+ reconstitution could take more than 10 months. The low number of lymphocytes infused with the graft, the degree of HLA (Human Leukocyte Antigen) disparity, and a reduced thymic function in adults and differences in host/donor antigen presenting cells are contributing causes. The infusions of HSV-TK engineered lymphocytes may represent a significant therapeutic improvement in haploidentical HCT (hematopoietic cell transplantation), because it remarkably may enhance both GvL (Graft versus Leukemia) activity, thus reducing the occurrence of disease relapse, and post-transplant immune reconstitution in the absence of chronic immune suppression, thus decreasing the rate of both post-transplant opportunistic infections and transplant-related mortality. Furthermore, the efficient control of GvHD achieved via the suicide mechanism allows also the multiple infusion of HSV-TK-treated donor lymphocytes, when needed, that might further improve post-transplant host immune reconstitution, and survival in patients receiving haplo-HCT. Finally, this therapeutic approach can become a valuable option for all candidates, including patients with advanced disease and older age. The proposed clinical trial represents an innovative therapeutic treatment for patients affected by high risk acute leukemia, who have undergone haploidentical stem cell transplantation.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States
Washington University Medical School, Saint Louis, Missouri, United States
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
Universitair Ziekenhuis, Gent, , Belgium
University Hospitals Leuven, Leuven, , Belgium
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman, Liège, , Belgium
Hôpital Jean Minjoz, Besançon, , France
Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, , France
Centre Hospitalier Régional Universitaire de Lille, Lille, , France
Institut Paoli-Calmettes, Marseille, , France
Centre Hospitalier Universitaire de Nantes, Nantes, , France
Hôpital l'Archet, Nice, , France
Hôpital Saint-Antoine, Paris, , France
IUCT Oncopole - Institut Universitaire du Cancer de Toulouse, Toulouse, , France
Charitè; Campus Benjamin Franklin, Berlin, , Germany
University Medical Center Hamburg-Eppendorf, Hamburg, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
University of Leipzig, Leipzig, , Germany
Universitat Tubingen, Tubingen, , Germany
Medizinische Klinik und Poliklinik, Ulm, , Germany
George Papanicolaou Hospital, Thessaloniki, , Greece
Chaim Sheba Medical Center, Tel Hashomer, , Israel
Azienda Sanitaria Ospedaliera S.Croce e Carle, Cuneo, CN, Italy
Azienda Ospedaliero-Universitaria Policlinico-Vittorio Emanuele, Catania, CT, Italy
Azienda Ospedaliera Universitaria Careggi, Firenze, FI, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello, Palermo, PA, Italy
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Presidio Molinette, Torino, TO, Italy
Ospedale Santa Maria della Misericordia, Udine, UD, Italy
Policlinico G. B. Rossi, Azienda ospedaliera universitaria integrata di Verona, Verona, VR, Italy
Ospedale San Raffaele, Milan, , Italy
Azienda Ospedaliero-Universitaria Policlinico di Modena, Modena, , Italy
Santaros Klinikos, Vilnius, , Lithuania
Centro Hospitalar Lisboa Norte, E.P.E., Lisboa, , Portugal
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Instituto Catalán de Oncología, L'Hospitalet De Llobregat, , Spain
Hospital de Navarra, Pamplona, , Spain
Contact Details
Name: Antonio Lambiase, MD
Affiliation: AGC Biologics S.p.A.
Role: STUDY_DIRECTOR
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