drugset / Trial / NCT00496431

phII Study of an HDAC Inhibitor in Very High-risk Relapsed/Refractory Hodgkin's Lymphoma Patients

NCT00496431

Phase 1/2 Terminated 19 enrolled Italfarmaco
NaSingle-groupOpen-labelTreatment

Summary

PRIMARY OBJECTIVE \- To evaluate the efficacy (according to the International Working Group response criteria for Hodgkin's Lymphomas \[7, 8, 9\]) of daily oral doses of ITF2357 administered to very high-risk Hodgkin's lymphoma patients. SECONDARY OBJECTIVES * To evaluate safety and tolerability of multiple oral doses of ITF2357 * To assess the proportion of patients that, after ITF2357 treatment, can undergo high-dose salvage chemotherapy with either autografting or allografting

Timeline

Start
2007-05
Primary completion
2009-03
Completion
2009-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Givinostat Small molecule 50 mg Oral

Indications