drugset / Trial / NCT00792831

Phase II Study of Histone-deacetylase Inhibitor ITF2357 in Refractory/Relapsed Lymphocytic Leukemia

NCT00792831

Phase 2 Terminated 3 enrolled Italfarmaco
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

EvaluationDrugModalityDoseRoute
Subject Givinostat Small molecule 100 mg Oral