drugset / Trial / NCT00792831
Phase II Study of Histone-deacetylase Inhibitor ITF2357 in Refractory/Relapsed Lymphocytic Leukemia
NaSingle-groupOpen-labelTreatment
Summary
Primary objective: \- To determine overall response-rate, complete response (CR) or partial response (PR) Secondary objectives: * To assess the safety and tolerability of ITF2357; * to assess total rate of responders (complete + partial responders); * to determine the 6 months progression free survival; * to determine the effects of the drug on haematological parameters.
Timeline
- Start
- 2008-02
- Primary completion
- 2009-04
- Completion
- 2009-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Givinostat | Small molecule | 100 mg | Oral |