Randomized Phase III of haploidentical HCT with or without an add back strategy of HSV-Tk donor lymphocytes in patients with high risk acute leukemia

Study title: 
Randomized Phase III of haploidentical HCT with or without an add back strategy of HSV-Tk donor lymphocytes in patients with high risk acute leukemia
Date receipt dossier: 
23 Apr 2012
EudraCT number: 
2009-012973-37
Pharmaceutical study code: 
IPR/21-TK008
Company / Sponsor: 
Molmed S.p.A.
Phase: 
III
Treated organism: 
Humans
Indication category: 
Cancer therapy
Disease: 
Acute leukemia
Therapeutic approach: 
Restore immunity + treatment of GVHD
Genetic modification: 
-Thymidine Kinase (HSV-Tk) - selection marker
Method of transfer of nucleic acid of interest: 
Moloney Murine Leukemia virus
Administered biological material: 
haploidentical donor T-lymphocytes expressing HSV-Tk
Route of administration: 
Intravenous
Locations in Belgium: 
UZ Leuven - AZ St Jan, Brugge - CHU Liège
Type of procedure: 
Contained use only