Acute Myeloid Leukaemia Clinical Trial
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
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.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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