drugset / Trial / NCT00572065
Pilot Trial of Arsenic + Cytarabine in Patients With Myelofibrosis
NaSingle-groupOpen-labelTreatment
Summary
This is an open-label, one arm, single institution study. Arsenic trioxide \[TrisenoxTM Injection\], 0.25mg/kg/dose administered intravenously over 2 hours. 20 patients Complete remission, partial remission, clinical improvement, progressive disease, stable disease, relapse (per IWG consensus criteria, 2006) Clinical chemistry, hematology and ECGs will be assessed at least weekly during study treatments. Adverse events will be assessed in accordance with the NCI Common Toxicity Criteria, Version 2 at each study visit.
Timeline
- Start
- 2008-02-29
- Primary completion
- 2009-12
- Completion
- 2010-02-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cytarabine | Small molecule | 10 mg/m2 | Subcutaneous |
| Subject | arsenic trioxide | Small molecule | 0.25 mg/kg | Intravenous |