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