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Brief Title: Treosulfan Based Conditioning Acute Myeloid Leukaemia (AML)
Official Title: Clinical Phase II Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation in Patients With Acute Myeloid Leukaemia
Study ID: NCT01063660
Brief Summary: This is a multicenter, multinational, 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 AML. 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: No
University of Rostock, Rostock, , Germany
Name: Mathias Freund, MD
Affiliation: University of Rostock
Role: PRINCIPAL_INVESTIGATOR