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

EudraCT number

2009-012973-37

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

Pharmaceutical study code

IPR/21-TK008

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