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

Hodgkin's Lymphoma Clinical Trial

Official title: Phase II Study of the Histone-deacetylase Inhibitor ITF2357 in Very High-risk Relapsed/Refractory Hodgkin's Lymphoma Patients

Status Terminated

Clinical Trial 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

Clinical Trial Description

This is a multi-center, open label, phase II study testing ITF2357 in a population of very high-risk relapsed/refractory Hodgkin's lymphoma patients.

The patients were planned to receive 50 mg ITF2357 four times a day at 6-hour intervals in fed conditions for 28 consecutive days unless evidence of progressive disease, presence of unacceptable adverse events or patient's request to discontinue treatment occurs.

Decision regarding the continuation of ITF2357 were made on:

• the basis of tumor reassessment upon completion of cycle defined as above and not later than 7 days and

• the occurred toxicity (if any).

If complete response or partial response or stabilization of disease after first cycle, without concomitant relevant toxicities is observed, the treatment may continue as long as there is no evidence of progressive disease or appearance of unacceptable adverse events.

In any case, the treatment is not planned to exceed 84 days of drug intake overall (i.e. 12 weeks).

The treatment is planned to be administered on an outpatient basis and patients are planned to be followed regularly with physical and laboratory tests, as specified in the protocol; in case of hospitalization, the treatment will be continued or interrupted according to the Investigators' decision.

The study planned to accrue 23 patients evaluable for efficacy and the anticipated duration of the study is about 18 months.

Actually, accrual was stopped earlier than planned by the Sponsor for 2 main reasons: a) a very slow recruitment rate; b) an unplanned interim analysis suggesting a lower than estimated efficacy of the drug when delivered as single agent. ;

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Lymphoma
• Lymphoma

• NCT number: NCT00496431
• Study type: Interventional
• Source: Italfarmaco
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: May 2007
• Completion date: March 2009