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

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

Timeline

Start

2010-04-12

Primary completion

2019-11-30

Completion

2019-11-30

Outcome

Missed primary endpoint

Stopped: “EMA withdrew the marketing Authorisation at the request of AGC Biologics S.p.A (formerly MolMed S.p.A), which decided to permanently discontinue the marketing of the product for commercial reasons”

registry analysis (superiority test); A-Experimental Arm vs B - Control Arm; p = 0.8974; Log Rank NCT00914628 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	HSV-Tk	Cell therapy	1e+07 cells/kg	—

Indications