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

NCT00496431 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2022-01-27

No results posted yet for this study

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

Conditions

  • Hodgkin's Lymphoma

Interventions

DRUG

histone deacetylase inhibitor (ITF2357)

50 mg b.i.d. (or every 8 hours or every 6 hours), every day

Sponsors & Collaborators

  • Italfarmaco

    lead INDUSTRY

Principal Investigators

  • Alessandro Massimo Gianni, MD · Istituto Nazionale per lo studio e la cura dei Tumori (Milan - Italy)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00496431 on ClinicalTrials.gov