NCT01062490

Treosulfan Based Conditioning Myelodysplastic Syndrome (MDS)

Clinical Phase II Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation in Patients With Myelodysplastic Syndrome (MDS)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: medac GmbH · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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 MDS. The aim is to demonstrate a clinical benefit compared to historical data with intravenous busulfan.

Conditions

• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	Treosulfan	14 g/m2/d, day -6 to -4

Timeline

• Start date: 2004-11-01
• Primary completion: 2008-07-01
• Completion: 2009-10-01
• First posted: 2010-02-04
• Last updated: 2010-02-04

Locations

1 site across 1 country: Finland