Efficacy Study on the Strategy of HSV-Tk Engineering Donor Lymphocytes to Treat Patients With High Risk Acute Leukemia

PHASE3TerminatedINTERVENTIONAL
Enrollment

92

Participants

Timeline

Start Date

April 12, 2010

Primary Completion Date

November 30, 2019

Study Completion Date

November 30, 2019

Conditions
Acute Leukemia (Category)
Interventions
GENETIC

HSV-Tk

Infusion of approximately 1±0.2 x 10\^7 HSV-Tk genetically modified CD3+ cells/Kg between day +21 and day +49 after haploidentical HCT; in absence of immune reconstitution and GvHD further infusions up to 4 will be administered on monthly basis.

OTHER

T-cell depleted or T-cell replete strategies

Haploidentical HCT with the infusion of CD34+ cells plus a fixed dose of T cells (1 x 10\^4/Kg) or unmanipulated haploidentical stem cell transplantation followed by high-dose cyclophosphamide as part of GvHD prophylaxis

Trial Locations (36)

3000

University Hospitals Leuven, Leuven

13353

Charitè; Campus Benjamin Franklin, Berlin

25030

Hôpital Jean Minjoz, Besançon

30625

Medizinische Hochschule Hannover, Hanover

31008

Hospital de Navarra, Pamplona

41124

Azienda Ospedaliero-Universitaria Policlinico di Modena, Modena

52621

Chaim Sheba Medical Center, Tel Litwinsky

57010

George Papanicolaou Hospital, Thessaloniki

60611

Northwestern University Feinberg School of Medicine, Chicago

63110

Washington University Medical School, St Louis

72076

Universitat Tubingen, Tübingen

89081

Medizinische Klinik und Poliklinik, Ulm

07601

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack

Unknown

Universitair Ziekenhuis, Ghent

Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman, Liège

Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand

Centre Hospitalier Régional Universitaire de Lille, Lille

Institut Paoli-Calmettes, Marseille

Centre Hospitalier Universitaire de Nantes, Nantes

Hôpital l'Archet, Nice

Hôpital Saint-Antoine, Paris

IUCT Oncopole - Institut Universitaire du Cancer de Toulouse, Toulouse

University Medical Center Hamburg-Eppendorf, Hamburg

Azienda Sanitaria Ospedaliera S.Croce e Carle, Cuneo

Azienda Ospedaliero-Universitaria Policlinico-Vittorio Emanuele, Catania

Azienda Ospedaliera Universitaria Careggi, Florence

Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello, Palermo

Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Presidio Molinette, Torino

Ospedale Santa Maria della Misericordia, Udine

Policlinico G. B. Rossi, Azienda ospedaliera universitaria integrata di Verona, Verona

Ospedale San Raffaele, Milan

Santaros Klinikos, Vilnius

Centro Hospitalar Lisboa Norte, E.P.E., Lisbon

Hospital de la Santa Creu i Sant Pau, Barcelona

Instituto Catalán de Oncología, L'Hospitalet de Llobregat

04103

University of Leipzig, Leipzig

Sponsors
All Listed Sponsors
lead

AGC Biologics S.p.A.

INDUSTRY