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

NCT00792831 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2022-01-27

No results posted yet for this study

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.

Conditions

Interventions

DRUG

ITF2357

Histone-Deacetylase Inhibitor

Sponsors & Collaborators

  • Italfarmaco

    lead INDUSTRY

Principal Investigators

  • Massimo Martelli, MD · Department of Internal Medicine and Public Health, University of Perugia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • Italy

Study Locations

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Entities

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 NCT00792831 on ClinicalTrials.gov