Trials / Completed
CompletedNCT01063660
Treosulfan Based Conditioning Acute Myeloid Leukaemia (AML)
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 75 (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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Treosulfan | 14 g/m²/d day -6 to -4 |
Timeline
- Start date
- 2004-03-01
- Completion
- 2007-07-01
- First posted
- 2010-02-05
- Last updated
- 2010-02-05
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT01063660. Inclusion in this directory is not an endorsement.