NCT00251511

A Phase II Trial of Trisenox Plus Thalomid as Treatment in Patients With Myelodysplastic Syndrome

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Veeda Oncology · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II, open-label, non-randomized study in patients with low, intermediate-1, intermediate-2, or high-risk MDS (defined by IPSS). Each cycle of treatment will be 6 weeks in length. Patients will be evaluated every 6 weeks for response. Patients will be treated for a minimum of 12 weeks even in the absence of response. Following 12 weeks of treatment, patients will continue to receive study treatment until disease progression or unacceptable toxicity.

Conditions

• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	Arsenic Trioxide

Timeline

• Start date: 2004-08-01
• Primary completion: 2006-01-01
• Completion: 2007-05-01
• First posted: 2005-11-10
• Last updated: 2012-05-11

Locations

1 site across 1 country: United States