Clinical Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation (HSCT)

Summary

This is a multicentric, non-randomized, non-controlled open-label phase II trial to evaluate the safety and efficacy of treosulfan in a combination regimen with fludarabine as conditioning therapy prior to allogeneic stem cell transplantation (SCT) in patients with haematological malignancies. The aim is to demonstrate a clinical benefit compared with historical data on intravenous busulfan (BusulfexTM, BusilvexTM), the only drug so far registered in the indication conditioning before allogeneic stem cell transplantation.

Timeline

Start

2005-09

Primary completion

2009-12

Completion

2010-12

Publications

• Lazzari L, Ruggeri A, Lupo Stanghellini MT, Mastaglio S, Messina C, Giglio F, Lorusso A, Perini T, Piemontese S, Marcatti M, Lorentino F, Xue E, Clerici D, Corti C, Bernardi M, Assanelli A, Greco R, Ciceri F, Peccatori J. Treosulfan-Based Conditioning Regimen Prior to Allogeneic Stem Cell Transplantation: Long-Term Results From a Phase 2 Clinical Trial. Front Oncol. 2021 Sep 10;11:731478. doi: 10.3389/fonc.2021.731478. eCollection 2021.

Drugs

Indications