A Phase 2 interventional study of Treosulfan in Myelodysplastic Syndrome, sponsored by medac GmbH. Completed at 1 site in Finland. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2010-02-04.
Sponsored by medac GmbH · Phase 2, Interventional, and Treatment
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.
1,317 studies on the registry are indexed under Preleukemia; 57 are open to participants now.
This study's enrollment of 45 is above the median of 36 across 1,060 interventional studies indexed under Preleukemia.
Browse Preleukemia studies →medac GmbH is the lead sponsor of 21 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with myelodysplastic syndrome, (MDS) according to WHO classification (\< 20 % myeloblasts in peripheral blood or bone marrow at initial diagnosis) indicated for allogeneic transplantation
Drug: Treosulfan
14 g/m2/d, day -6 to -4
Also known as: Ovastat
Efficacy: Evaluation of engraftment
Time frame: 4 years
Safety: Evaluation of CTC grade 3 and 4 adverse events between Day -6 and Day +28: hyperbilirubinemia and mucositis/stomatitis, veno-occlusive disease, seizures
Time frame: 4 years
This study is completed, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.
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